WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss SUBMISSIONS & PUBLISHING SERVICES Submissions & Publishing. Our Regulatory Strategy and Submissions Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Every member of this team has at least 10 years of experience in PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

4 TYPES OF DOSE FINDING STUDIES USED IN PHASE II CLINICAL 4 Types of Dose Finding Studies Used in Phase II Clinical Trials. One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

BRANDY LIND, SENIOR DIRECTOR, PROJECT MANAGEMENT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D TWO AND FOUR HOUR TESTS DIFFER IN CAPTURE OF C-PEPTIDE Two and Four Hour Tests Differ in Capture of C-peptide Responses to a Mixed Meal Karen Boyle, Kevan Herold, Mario Ehlers, Mark Rigby, Jim McNamara, Tara Ghazi, Lia Weiner, Ashley Pinckney, WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss SUBMISSIONS & PUBLISHING SERVICES Submissions & Publishing. Our Regulatory Strategy and Submissions Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Every member of this team has at least 10 years of experience in PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

4 TYPES OF DOSE FINDING STUDIES USED IN PHASE II CLINICAL 4 Types of Dose Finding Studies Used in Phase II Clinical Trials. One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

BRANDY LIND, SENIOR DIRECTOR, PROJECT MANAGEMENT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D TWO AND FOUR HOUR TESTS DIFFER IN CAPTURE OF C-PEPTIDE Two and Four Hour Tests Differ in Capture of C-peptide Responses to a Mixed Meal Karen Boyle, Kevan Herold, Mario Ehlers, Mark Rigby, Jim McNamara, Tara Ghazi, Lia Weiner, Ashley Pinckney, CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. CONTACT US | UNITY + RHO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and THE FOUNDATIONAL ASPECTS OF DECENTRALIZED CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

CLINICAL STUDIES REQUIRED FOR A 505(B)(2) DEVELOPMENT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUCCESSFUL NDA SUBMISSION FOR A BREAKTHROUGH PRODUCT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and FOLLOW UP: NON-STATISTICIANS AND STATISTICS IN CLINICAL Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

ISCTM | RHO

Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SITE INVESTIGATOR VS. SPONSOR SAE CAUSALITY: ARE THEY Both the site investigator and the sponsor assess causality for every SAE. Causality is whether there is a reasonable possibility that the drug caused the event. The FDA believes the sponsor can better assess causality as they have access to SAE reports from multiple sites and studies along with a familiarity with the drug’s mechanism of

action.

CTAD (CLINICAL TRIALS ON ALZHEIMER'S DISEASE) Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study MEDICAL WRITING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss CONVERTING LEGACY DATA TO CDISC STANDARDS: KEY QUESTIONS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

4 TYPES OF DOSE FINDING STUDIES USED IN PHASE II CLINICAL 4 Types of Dose Finding Studies Used in Phase II Clinical Trials. One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study MEDICAL WRITING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss CONVERTING LEGACY DATA TO CDISC STANDARDS: KEY QUESTIONS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

4 TYPES OF DOSE FINDING STUDIES USED IN PHASE II CLINICAL 4 Types of Dose Finding Studies Used in Phase II Clinical Trials. One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option CONTACT US | UNITY + RHO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and MEDICAL MONITORING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and MEDICAL WRITING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and THE FOUNDATIONAL ASPECTS OF DECENTRALIZED CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

CLINICAL STUDIES REQUIRED FOR A 505(B)(2) DEVELOPMENT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUCCESSFUL NDA SUBMISSION FOR A BREAKTHROUGH PRODUCT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CTAD (CLINICAL TRIALS ON ALZHEIMER'S DISEASE) Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CULTURE FIT INTERVIEWS: WHAT ARE THEY AND WHY DO WE DO What it is. The purpose of the culture fit interview is to make sure that each employee we bring on board shares and embodies the same values that we do. These interviews are conducted by a select set of senior leaders who have been with the company for quite a while. The interviews do not assess skills or technical qualifications, and CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study MEDICAL WRITING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D 4 TYPES OF DOSE FINDING STUDIES USED IN PHASE II CLINICAL 4 Types of Dose Finding Studies Used in Phase II Clinical Trials. One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study MEDICAL WRITING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D 4 TYPES OF DOSE FINDING STUDIES USED IN PHASE II CLINICAL 4 Types of Dose Finding Studies Used in Phase II Clinical Trials. One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option CONTACT US | UNITY + RHO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CLINICAL STUDIES REQUIRED FOR A 505(B)(2) DEVELOPMENT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUCCESSFUL NDA SUBMISSION FOR A BREAKTHROUGH PRODUCT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and MEDICAL MONITORING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and MEDICAL WRITING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and THE FOUNDATIONAL ASPECTS OF DECENTRALIZED CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

5 LESSONS LEARNED CONDUCTING ADHD CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

CULTURE FIT INTERVIEWS: WHAT ARE THEY AND WHY DO WE DO What it is. The purpose of the culture fit interview is to make sure that each employee we bring on board shares and embodies the same values that we do. These interviews are conducted by a select set of senior leaders who have been with the company for quite a while. The interviews do not assess skills or technical qualifications, and SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss

CONTACT US | RHO

Contact Us. Our office is located at 2635 E NC Hwy 54, Durham, NC 27713. Click here for directions. To work with Rho or learn more about us, complete the form below or call 919-408-8000. Note: Clinical sites and investigators should use the form located on our Sites/Investigator page to submit your contact information to our Investigator Database. PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

4 TYPES OF DOSE FINDING STUDIES USED IN PHASE II CLINICAL 4 Types of Dose Finding Studies Used in Phase II Clinical Trials. One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option TWO AND FOUR HOUR TESTS DIFFER IN CAPTURE OF C-PEPTIDE Two and Four Hour Tests Differ in Capture of C-peptide Responses to a Mixed Meal Karen Boyle, Kevan Herold, Mario Ehlers, Mark Rigby, Jim McNamara, Tara Ghazi, Lia Weiner, Ashley Pinckney, CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss

CONTACT US | RHO

Contact Us. Our office is located at 2635 E NC Hwy 54, Durham, NC 27713. Click here for directions. To work with Rho or learn more about us, complete the form below or call 919-408-8000. Note: Clinical sites and investigators should use the form located on our Sites/Investigator page to submit your contact information to our Investigator Database. PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as SIMPLIFY PATIENT CENTRICITY 4.0 Practical Strategies to Simplify Patient Centricity: Part 4—Practical and Easier than You Might Think. June 20, 2017. Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community

Healthcare for

4 TYPES OF DOSE FINDING STUDIES USED IN PHASE II CLINICAL 4 Types of Dose Finding Studies Used in Phase II Clinical Trials. One of the key goals of phase II is to determine the optimal dose that you will use going into your phase III trials and that ultimately will be used on your product label submitted for approval as part of the new drug application (NDA). The optimal dose is the dose that is high DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option TWO AND FOUR HOUR TESTS DIFFER IN CAPTURE OF C-PEPTIDE Two and Four Hour Tests Differ in Capture of C-peptide Responses to a Mixed Meal Karen Boyle, Kevan Herold, Mario Ehlers, Mark Rigby, Jim McNamara, Tara Ghazi, Lia Weiner, Ashley Pinckney, THE FOUNDATIONAL ASPECTS OF DECENTRALIZED CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

SUBMISSIONS & PUBLISHING SERVICES Submissions & Publishing. Our Regulatory Strategy and Submissions Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Every member of this team has at least 10 years of experience in MEDICAL WRITING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Functional Clinical Support Services & Our Expertise. Rho’s Statistical and Programming team has consistently provided high quality deliverables, with an eye for detail that is both comprehensive and insightful. The team’s dedication has been evident in each step of the process and the results have proven to be exemplary by any standard. PRODUCT SAFETY IN CLINICAL TRIALS Throughout the life cycle of the program, Product Safety ensures timelines are met in global safety reporting in clinical trials, supports and educates site staff, and provides a safety profile through management and analysis of the safety data as part of their pharmacovigilance services. Our experienced, highly trained safety

team is composed

SITE INVESTIGATOR VS. SPONSOR SAE CAUSALITY: ARE THEY Both the site investigator and the sponsor assess causality for every SAE. Causality is whether there is a reasonable possibility that the drug caused the event. The FDA believes the sponsor can better assess causality as they have access to SAE reports from multiple sites and studies along with a familiarity with the drug’s mechanism of

action.

FOLLOW UP: NON-STATISTICIANS AND STATISTICS IN CLINICAL Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

LAURA HELMS REECE, DR. P.H., CHIEF EXECUTIVE OFFICER Laura Helms Reece, Dr. P.H. CEO. Recognized as a “Top Businesswoman” by the Triangle Business Journal and a graduate of Harvard Business School’s prestigious Owner/President Management Program, Dr. Laura Helms Reece has been Rho’s CEO since 2011. After cutting her teeth in clinical research as a Data Processor at Rho in

1991, Dr. Helms

PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D BRANDY LIND, SENIOR DIRECTOR, PROJECT MANAGEMENT Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study WORKING AT RHO: REWARDING CAREERS WITH A FULL-SERVICE CRO Experience a rewarding career with a full-service CRO. At Rho, we have developed a reputation for providing an unsurpassed degree of expertise, integrity, and passion for clinical research. We have achieved this reputation by focusing on long-term goals, and we expect our employees to possess similar forward-looking vision. MEDICAL MONITORING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUBMISSIONS & PUBLISHING SERVICES Submissions & Publishing. Our Regulatory Strategy and Submissions Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Every member of this team has at least 10 years of experience in FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Functional Clinical Support Services & Our Expertise. Rho’s Statistical and Programming team has consistently provided high quality deliverables, with an eye for detail that is both comprehensive and insightful. The team’s dedication has been evident in each step of the process and the results have proven to be exemplary by any standard. PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as CULTURE FIT INTERVIEWS: WHAT ARE THEY AND WHY DO WE DO What it is. The purpose of the culture fit interview is to make sure that each employee we bring on board shares and embodies the same values that we do. These interviews are conducted by a select set of senior leaders who have been with the company for quite a while. The interviews do not assess skills or technical qualifications, and DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study WORKING AT RHO: REWARDING CAREERS WITH A FULL-SERVICE CRO Experience a rewarding career with a full-service CRO. At Rho, we have developed a reputation for providing an unsurpassed degree of expertise, integrity, and passion for clinical research. We have achieved this reputation by focusing on long-term goals, and we expect our employees to possess similar forward-looking vision. MEDICAL MONITORING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUBMISSIONS & PUBLISHING SERVICES Submissions & Publishing. Our Regulatory Strategy and Submissions Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Every member of this team has at least 10 years of experience in FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Functional Clinical Support Services & Our Expertise. Rho’s Statistical and Programming team has consistently provided high quality deliverables, with an eye for detail that is both comprehensive and insightful. The team’s dedication has been evident in each step of the process and the results have proven to be exemplary by any standard. PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as CULTURE FIT INTERVIEWS: WHAT ARE THEY AND WHY DO WE DO What it is. The purpose of the culture fit interview is to make sure that each employee we bring on board shares and embodies the same values that we do. These interviews are conducted by a select set of senior leaders who have been with the company for quite a while. The interviews do not assess skills or technical qualifications, and DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option

CONTACT US | RHO

Contact Us. Our office is located at 2635 E NC Hwy 54, Durham, NC 27713. Click here for directions. To work with Rho or learn more about us, complete the form below or call 919-408-8000. Note: Clinical sites and investigators should use the form located on our Sites/Investigator page to submit your contact information to our Investigator Database. FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Functional Clinical Support Services & Our Expertise. Rho’s Statistical and Programming team has consistently provided high quality deliverables, with an eye for detail that is both comprehensive and insightful. The team’s dedication has been evident in each step of the process and the results have proven to be exemplary by any standard. RHO'S BOARD OF DIRECTORS: COMPANY LEADERSHIP Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SPECIALTY CNS, NEUROLOGY AND PSYCHIATRY CRO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and THE FOUNDATIONAL ASPECTS OF DECENTRALIZED CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

5 LESSONS LEARNED CONDUCTING ADHD CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss FOLLOW UP: NON-STATISTICIANS AND STATISTICS IN CLINICAL Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

4 REASONS LOW EMPLOYEE TURNOVER IS CRITICAL IN CRO Employee turnover rates across the CRO industry are incredibly high. In 2014, the overall CRO turnover rate was 19.5% and was even higher (25.4%) among CRAs. As a Sponsor selecting a CRO, why should this matter to you? The higher a CRO’s employee turnover rate, the more likely that team members assigned to your study will change over the course of the project. PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study WORKING AT RHO: REWARDING CAREERS WITH A FULL-SERVICE CRO Experience a rewarding career with a full-service CRO. At Rho, we have developed a reputation for providing an unsurpassed degree of expertise, integrity, and passion for clinical research. We have achieved this reputation by focusing on long-term goals, and we expect our employees to possess similar forward-looking vision. MEDICAL MONITORING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUBMISSIONS & PUBLISHING SERVICES Submissions & Publishing. Our Regulatory Strategy and Submissions Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Every member of this team has at least 10 years of experience in FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Functional Clinical Support Services & Our Expertise. Rho’s Statistical and Programming team has consistently provided high quality deliverables, with an eye for detail that is both comprehensive and insightful. The team’s dedication has been evident in each step of the process and the results have proven to be exemplary by any standard. PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as CULTURE FIT INTERVIEWS: WHAT ARE THEY AND WHY DO WE DO What it is. The purpose of the culture fit interview is to make sure that each employee we bring on board shares and embodies the same values that we do. These interviews are conducted by a select set of senior leaders who have been with the company for quite a while. The interviews do not assess skills or technical qualifications, and DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Sites and Investigators. Thank you for your interest in working with Rho. We are currently accepting additions to our investigator database in the following therapeutic areas: pain, rare disease, CNS, infectious disease and vaccines, allergy, asthma, transplantation, and autoimmune disease. We will update this page regularly as our study WORKING AT RHO: REWARDING CAREERS WITH A FULL-SERVICE CRO Experience a rewarding career with a full-service CRO. At Rho, we have developed a reputation for providing an unsurpassed degree of expertise, integrity, and passion for clinical research. We have achieved this reputation by focusing on long-term goals, and we expect our employees to possess similar forward-looking vision. MEDICAL MONITORING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUBMISSIONS & PUBLISHING SERVICES Submissions & Publishing. Our Regulatory Strategy and Submissions Team is a highly experienced group of regulatory affairs professionals that provides critical document and marketing application submission services for many of our regulatory strategy and clinical projects. Every member of this team has at least 10 years of experience in FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Functional Clinical Support Services & Our Expertise. Rho’s Statistical and Programming team has consistently provided high quality deliverables, with an eye for detail that is both comprehensive and insightful. The team’s dedication has been evident in each step of the process and the results have proven to be exemplary by any standard. PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Programs to Support Drug Development in Infectious Disease: GAIN, QIDP, and LPAD. April 15, 2020. According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result . Antibiotic resistance is on the rise as CULTURE FIT INTERVIEWS: WHAT ARE THEY AND WHY DO WE DO What it is. The purpose of the culture fit interview is to make sure that each employee we bring on board shares and embodies the same values that we do. These interviews are conducted by a select set of senior leaders who have been with the company for quite a while. The interviews do not assess skills or technical qualifications, and DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Denise Babineau, Ph.D. Senior Research Scientist. Denise Babineau holds a M.S. in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical

centers in

ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option

CONTACT US | RHO

Contact Us. Our office is located at 2635 E NC Hwy 54, Durham, NC 27713. Click here for directions. To work with Rho or learn more about us, complete the form below or call 919-408-8000. Note: Clinical sites and investigators should use the form located on our Sites/Investigator page to submit your contact information to our Investigator Database. FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Functional Clinical Support Services & Our Expertise. Rho’s Statistical and Programming team has consistently provided high quality deliverables, with an eye for detail that is both comprehensive and insightful. The team’s dedication has been evident in each step of the process and the results have proven to be exemplary by any standard. RHO'S BOARD OF DIRECTORS: COMPANY LEADERSHIP Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SPECIALTY CNS, NEUROLOGY AND PSYCHIATRY CRO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and THE FOUNDATIONAL ASPECTS OF DECENTRALIZED CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

5 LESSONS LEARNED CONDUCTING ADHD CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss FOLLOW UP: NON-STATISTICIANS AND STATISTICS IN CLINICAL Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

4 REASONS LOW EMPLOYEE TURNOVER IS CRITICAL IN CRO Employee turnover rates across the CRO industry are incredibly high. In 2014, the overall CRO turnover rate was 19.5% and was even higher (25.4%) among CRAs. As a Sponsor selecting a CRO, why should this matter to you? The higher a CRO’s employee turnover rate, the more likely that team members assigned to your study will change over the course of the project. PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and WORKING AT RHO: REWARDING CAREERS WITH A FULL-SERVICE CRO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUBMISSIONS & PUBLISHING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and MEDICAL MONITORING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CULTURE FIT INTERVIEWS: WHAT ARE THEY AND WHY DO WE DO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Kathleen Candando, PhD, Research Scientist, authors regulatory submission documents and contributes to regulatory strategy and product development services.Dr. Candando has more than 10 years of experience in writing, reviewing, and editing scientific documents and frequently leads authorship of regulatory submissions including US IND and NDA modules, clinical study reports, ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option CHANGING WHAT IT MEANS TO WORK WITH A CRO Changing what it means to work with a CRO. At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. WORKING WITH RHO: SITES AND INVESTIGATORS APPLICATION Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and WORKING AT RHO: REWARDING CAREERS WITH A FULL-SERVICE CRO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SUBMISSIONS & PUBLISHING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and MEDICAL MONITORING SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and CULTURE FIT INTERVIEWS: WHAT ARE THEY AND WHY DO WE DO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and DENISE BABINEAU, PH.D., SENIOR RESEARCH SCIENTIST Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and PROGRAMS TO SUPPORT DRUG DEVELOPMENT IN INFECTIOUS Kathleen Candando, PhD, Research Scientist, authors regulatory submission documents and contributes to regulatory strategy and product development services.Dr. Candando has more than 10 years of experience in writing, reviewing, and editing scientific documents and frequently leads authorship of regulatory submissions including US IND and NDA modules, clinical study reports, ODDS RATIOS IN A TABULAR PRESENTATION ODDS RATIOS IN A TABULAR PRESENTATION Stephen M. Noga, UNC-CH, Chapel Hill, NC Ding Yi Zhao, UNC-CH, Chapel Hill, NC Abstract Odds ratios and their corresponding confidence intervals are easilyobtainable statistics using the ‘RLJ option FUNCTIONAL SERVICE PROVIDER (FSP) SERVICES Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and

CONTACT US | RHO

Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and RHO'S BOARD OF DIRECTORS: COMPANY LEADERSHIP Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and SPECIALTY CNS, NEUROLOGY AND PSYCHIATRY CRO Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and THE FOUNDATIONAL ASPECTS OF DECENTRALIZED CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

CONSIDERATIONS FOR IMPLEMENTING DECENTRALIZED CLINICAL The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide added benefits, including an improved patient experience by increasing engagement and reducing patient burden. We will discuss 5 LESSONS LEARNED CONDUCTING ADHD CLINICAL TRIALS Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

FOLLOW UP: NON-STATISTICIANS AND STATISTICS IN CLINICAL Clinical Development; Clinical Trials. Clinical Trials. Through decades of focused therapeutic expertise, strong site and investigator relationships and an insider’s understanding of the regulatory landscape, Rho’s team of experts ensure consistent trials—traditional, virtual, and hybrid—that run smarter and more

efficiently.

4 REASONS LOW EMPLOYEE TURNOVER IS CRITICAL IN CRO Employee turnover rates across the CRO industry are incredibly high. In 2014, the overall CRO turnover rate was 19.5% and was even higher (25.4%) among CRAs. As a Sponsor selecting a CRO, why should this matter to you? The higher a CRO’s employee turnover rate, the more likely that team members assigned to your study will change over the course of the project. PDUFA V: WHAT YOU NEED TO KNOW THE DRUG USER FEE ACT PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act. David Shoemaker, PhD. Senior Vice President, R&D Skip to main content _ Toggle navigation _

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WELCOME TO A DIFFERENT KIND OF CRO. Bringing your product to market takes something different. At Rho, we’re experienced, creative problem-solvers who provide outstanding clinical drug development services fueled by our unique team approach. Our dedication to collaboration makes your clinical trials and programs run smarter and more efficiently.

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Our People Make the Difference The people in these pictures work at Rho. They are project managers, CRAs, biostatisticians, data managers, administrative assistants, proposal analysts, accountants, and programmers. They are the best and brightest in the industry, and together, they solve some of the toughest problems in clinical research. These smart, creative, experienced, dedicated, fun people make us what we are—a top-notch CRO and a great place to grow a career. Learn more about the folks in the pictures by following this link

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Regulatory submissions High quality submissions accelerate time to market and bring the benefit of new treatments to patients.

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Clinical Data Management Our data experts have unrivaled skill at considering all the variables within a protocol and translating that information into a reliable clinical database, a rigorous edit-check plan, and an effective data-cleaning strategy.

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RECENT NEWS

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Rho: 'The hurdles are high when you have a drug that the world

doesn’t need'

Published 10/01/19

Check out Outsourcing Pharma's interview with Rho's Jack Modell and

Matt Healy...

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The Gene Therapy Product Development Process

Published 09/09/19

Check out David Shoemaker's, Senior Vice President, Research & Development, article in July 2019's _Applied Clinical Trials_.

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Rho Opens New Headquarters in Research Triangle Park

Published 07/21/19

Check out _919 Magazine's_ article on page 55  about Rho's New HQ

here !

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RECENT EVENTS

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ASCP Annual Meeting

May 26, 2020 (All day) to May 29, 2020 (All day) We hope to see you at the ASCP Annual Meeting in sunny Miami!

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DIA 2020

June 14, 2020 (All day) to June 18, 2020 (All day) Join us at DIA 2020 where exploring the impacts and opportunities brought about by the convergence of science,...

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Rare Disease Innovation and Partnering Summit June 24, 2020 (All day) to June 25, 2020 (All day) Stop by our booth to meet our experts and grab a coloring book!

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