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Our proven subject matter experts have the expertise and passion to create, innovate, and contribute to the success of our clients. Our Experts span multiple functions throughout each industry, and we are currently looking to expand our capabilities in our Centers of Excellence: Quality, Regulatory, and Clinical. If your experiencematches
EXPERT EXPERIENCE ARCHIVES Consulting, like most professions, requires training and practice. YourEncore has helped thousands of experts make this transition successfully and has compiled 10 tips for delighting your client every time. Adapt to increased skepticism and no authority. Everything you disliked about consultants when you were inside a company is now aheadwind
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Non-Alcoholic Steatohepatitis (NASH) is a specific metabolic disorder that manifests within the liver, possibly progressing to liver fibrosis and end-stage cirrhosis, as well as associating with an increased risk of cardiovascular (CV) morbidity & mortality and Type 2 Diabetes. Throughout the industrialized world today, the most commoncause of
SIGN IN - YOURENCORE connect with us. Follow us and explore more great content. join us. Join the YourEncore Expert Community. Expert Hub. Copyright © 2019 YourEncore. All rights reserved. YOURENCORE COVID-19 RESPONSE COVID-19 Support. Since our founding over 16 years ago, YourEncore has been at the forefront of delivering bespoke, virtual teams of experienced industry experts to deliver outcomes-oriented solutions to our clients in the face of their most pressing challenges. Now more than ever, we stand ready to leverage our collective strength, and our YOURENCORE'S READYQMS YourEncore’s ReadyQMS is designed to help lean, fast-moving organizations reduce risk and ensure regulatory compliance. Developed by a leading-edge team of Quality experts, ReadyQMS translates the industry-standard approach for Quality Management Systems into an agile, fit-for-purpose solution created to not overburden growingcompanies.
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Our proven subject matter experts have the expertise and passion to create, innovate, and contribute to the success of our clients. Our Experts span multiple functions throughout each industry, and we are currently looking to expand our capabilities in our Centers of Excellence: Quality, Regulatory, and Clinical. If your experiencematches
EXPERT EXPERIENCE ARCHIVES Consulting, like most professions, requires training and practice. YourEncore has helped thousands of experts make this transition successfully and has compiled 10 tips for delighting your client every time. Adapt to increased skepticism and no authority. Everything you disliked about consultants when you were inside a company is now aheadwind
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Non-Alcoholic Steatohepatitis (NASH) is a specific metabolic disorder that manifests within the liver, possibly progressing to liver fibrosis and end-stage cirrhosis, as well as associating with an increased risk of cardiovascular (CV) morbidity & mortality and Type 2 Diabetes. Throughout the industrialized world today, the most commoncause of
SIGN IN - YOURENCORE connect with us. Follow us and explore more great content. join us. Join the YourEncore Expert Community. Expert Hub. Copyright © 2019 YourEncore. All rights reserved. YOURENCORE COVID-19 RESPONSE COVID-19 Support. Since our founding over 16 years ago, YourEncore has been at the forefront of delivering bespoke, virtual teams of experienced industry experts to deliver outcomes-oriented solutions to our clients in the face of their most pressing challenges. Now more than ever, we stand ready to leverage our collective strength, and our YOURENCORE'S READYQMS YourEncore’s ReadyQMS is designed to help lean, fast-moving organizations reduce risk and ensure regulatory compliance. Developed by a leading-edge team of Quality experts, ReadyQMS translates the industry-standard approach for Quality Management Systems into an agile, fit-for-purpose solution created to not overburden growingcompanies.
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Ilana Meskin, Managing Expert, YourEncore Clinical Center of Excellence, reviews M&A Culture within biopharma, the strides it has taken, and the peaks organizations have yet to reach. YOURENCORE COVID-19 RESPONSE COVID-19 Support. Since our founding over 16 years ago, YourEncore has been at the forefront of delivering bespoke, virtual teams of experienced industry experts to deliver outcomes-oriented solutions to our clients in the face of their most pressing challenges. Now more than ever, we stand ready to leverage our collective strength, and our YOURENCORE CLINICAL DATA QUALITY REVIEWS YourEncore’s Clinical Data Quality Reviews offer an end-to-end approach to identifying the root cause of data quality issues and prioritizing and remediating those issues through a comprehensive Corrective Action and Preventative Action (CAPA) plan. The solution is led by the expert leadership of Jane Wood, Principal for our QualityCenter of
YOURENCORE'S READYQMS YourEncore’s ReadyQMS is designed to help lean, fast-moving organizations reduce risk and ensure regulatory compliance. Developed by a leading-edge team of Quality experts, ReadyQMS translates the industry-standard approach for Quality Management Systems into an agile, fit-for-purpose solution created to not overburden growingcompanies.
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This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful. END-TO-END APPROACH TO CLINICAL DEVELOPMENT As life science companies have evolved to achieve greater scale and operational efficiency and cope with rapid changes in technology and regulatory requirements, they have also become increasingly complex, highly matrixed organizations with more specialized roles andprocesses.
YOURENCORE VIDEO CASE STUDY: VERO BIOTECH 0:00 / 2:37. Live. •. An innovative, growing biotech company, Vero Biotech, needed support getting through the challenging approval process for a complex drug/device combination. From strategy to execution, YourEncore provided the support Vero Biotech needed to navigate the 510 (k) and NDA filing processes and get their therapy tomarket.
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Our proven subject matter experts have the expertise and passion to create, innovate, and contribute to the success of our clients. Our Experts span multiple functions throughout each industry, and we are currently looking to expand our capabilities in our Centers of Excellence: Quality, Regulatory, and Clinical. If your experiencematches
EXPERT EXPERIENCE ARCHIVES Consulting, like most professions, requires training and practice. YourEncore has helped thousands of experts make this transition successfully and has compiled 10 tips for delighting your client every time. Adapt to increased skepticism and no authority. Everything you disliked about consultants when you were inside a company is now aheadwind
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Non-Alcoholic Steatohepatitis (NASH) is a specific metabolic disorder that manifests within the liver, possibly progressing to liver fibrosis and end-stage cirrhosis, as well as associating with an increased risk of cardiovascular (CV) morbidity & mortality and Type 2 Diabetes. Throughout the industrialized world today, the most commoncause of
YOURENCORE COVID-19 RESPONSE COVID-19 Support. Since our founding over 16 years ago, YourEncore has been at the forefront of delivering bespoke, virtual teams of experienced industry experts to deliver outcomes-oriented solutions to our clients in the face of their most pressing challenges. Now more than ever, we stand ready to leverage our collective strength, and our SIGN IN - YOURENCORE connect with us. Follow us and explore more great content. join us. Join the YourEncore Expert Community. Expert Hub. Copyright © 2019 YourEncore. All rights reserved. YOURENCORE'S READYQMS YourEncore’s ReadyQMS is designed to help lean, fast-moving organizations reduce risk and ensure regulatory compliance. Developed by a leading-edge team of Quality experts, ReadyQMS translates the industry-standard approach for Quality Management Systems into an agile, fit-for-purpose solution created to not overburden growingcompanies.
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YOURENCORE CLINICAL DATA QUALITY REVIEWS YourEncore’s Clinical Data Quality Reviews offer an end-to-end approach to identifying the root cause of data quality issues and prioritizing and remediating those issues through a comprehensive Corrective Action and Preventative Action (CAPA) plan. The solution is led by the expert leadership of Jane Wood, Principal for our QualityCenter of
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Our proven subject matter experts have the expertise and passion to create, innovate, and contribute to the success of our clients. Our Experts span multiple functions throughout each industry, and we are currently looking to expand our capabilities in our Centers of Excellence: Quality, Regulatory, and Clinical. If your experiencematches
EXPERT EXPERIENCE ARCHIVES Consulting, like most professions, requires training and practice. YourEncore has helped thousands of experts make this transition successfully and has compiled 10 tips for delighting your client every time. Adapt to increased skepticism and no authority. Everything you disliked about consultants when you were inside a company is now aheadwind
REGULATORY ARCHIVES
Non-Alcoholic Steatohepatitis (NASH) is a specific metabolic disorder that manifests within the liver, possibly progressing to liver fibrosis and end-stage cirrhosis, as well as associating with an increased risk of cardiovascular (CV) morbidity & mortality and Type 2 Diabetes. Throughout the industrialized world today, the most commoncause of
YOURENCORE COVID-19 RESPONSE COVID-19 Support. Since our founding over 16 years ago, YourEncore has been at the forefront of delivering bespoke, virtual teams of experienced industry experts to deliver outcomes-oriented solutions to our clients in the face of their most pressing challenges. Now more than ever, we stand ready to leverage our collective strength, and our SIGN IN - YOURENCORE connect with us. Follow us and explore more great content. join us. Join the YourEncore Expert Community. Expert Hub. Copyright © 2019 YourEncore. All rights reserved. YOURENCORE'S READYQMS YourEncore’s ReadyQMS is designed to help lean, fast-moving organizations reduce risk and ensure regulatory compliance. Developed by a leading-edge team of Quality experts, ReadyQMS translates the industry-standard approach for Quality Management Systems into an agile, fit-for-purpose solution created to not overburden growingcompanies.
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YOURENCORE CONFIDENTIALITY AGREEMENT. This Confidentiality Agreement is made by and between myself, (as an "Expert"), and YourEncore, Inc., an Indiana corporation whose address is 20 North Meridian Street, Suite 800, Indianapolis, IN 46204 ("YourEncore"). In consideration for YourEncore's potential employment/ engagement of the Expert, and forLOGIN | EXPERTS
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YOURENCORE CLINICAL DATA QUALITY REVIEWS YourEncore’s Clinical Data Quality Reviews offer an end-to-end approach to identifying the root cause of data quality issues and prioritizing and remediating those issues through a comprehensive Corrective Action and Preventative Action (CAPA) plan. The solution is led by the expert leadership of Jane Wood, Principal for our QualityCenter of
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Ilana Meskin, Managing Expert, YourEncore Clinical Center of Excellence, reviews M&A Culture within biopharma, the strides it has taken, and the peaks organizations have yet to reach.QUALITY ARCHIVES
Webinar – Remote Monitoring in the COVID-19 Era. Developed and led by Liz Wool, Managing Expert with YourEncore’s Quality Center of Excellence, our team discusses the regulatory insights and practical guidance needed to modify and execute monitoring plans for remote monitoring in the COVID-19 era. YOURENCORE PANDEMIC RESPONSE ASSESSMENT The COVID-19 pandemic forced the immediate implementation of large-scale crisis response initiatives in global clinical trials. As life science companies prepare to move into the next stage of recovery, now is the time to assess the changes that were implemented and refine continuity plans to ensure regulatory compliance, patient safety, and organizational preparedness now and into the future. YOURENCORE'S READYQMS YourEncore’s ReadyQMS is designed to help lean, fast-moving organizations reduce risk and ensure regulatory compliance. Developed by a leading-edge team of Quality experts, ReadyQMS translates the industry-standard approach for Quality Management Systems into an agile, fit-for-purpose solution created to not overburden growingcompanies.
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Download this white paper for practical guidance on a standardized approach to developing a data strategy. Written by Hugh Donovan, Managing Expert with YourEncore’s Clinical Center of Excellence, this methodology is designed to be customized to a company’s current needs with the flexibility to evolve as those needs change. Topicscovered
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Quality management used to be about completing checkbox audits, meeting compliance requirements, and reacting to problems. Today, pharmaceutical companies of all sizes are seeking to transform the way they manage quality to be more strategic and more proactive.FREE WHITE PAPER
Vendor management and oversight is not only a regulatory imperative; it is a business imperative. Proper oversight is critical to ensuring patient safety, as well as mitigating the risks and financial implications of costly change orders, trial delays, non-productive clinical sites, rework (e.g. amendments), and data quality issues.FREE WHITE PAPER
In this second part of our new, two-part series, author Margaret McShane provides valuable insights on the program-level considerations required to support the execution of the Clinical Development Plan (CDP) and, in particular, how recent updates in regulations, such as draft ICH E8 (R1), are changing the IMP development process.FREE WHITE PAPER
In this white paper, Clinical Expert Margaret McShane, examines the concepts of the Draft ICH E8 (R1) Guidelines and discusses their impact on the clinical development program.HOME
Our Subject Matter Experts. YourEncore Experts include a diverse mix of highly experienced, technical professionals from the Life Sciences industry. Our proven subject matter experts have the expertise and passion to create, innovate, and contribute to the success of ourclients.
YOURENCORE COVID-19 RESPONSE Since our founding over 16 years ago, YourEncore has been at the forefront of delivering bespoke, virtual teams of experienced industry experts to deliver outcomes-oriented solutions to our clients in the face of their most pressing challenges.REGULATORY ARCHIVES
Non-Alcoholic Steatohepatitis (NASH) is a specific metabolic disorder that manifests within the liver, possibly progressing to liver fibrosis and end-stage cirrhosis, as well as associating with an increased risk of cardiovascular (CV) morbidity & mortality and Type 2Diabetes.
ACCESS ASSISTANTACCESS ASSISTANT EXTENSIONACCESS ASSISTANT EXTENSIONLEVEL ACCESS ASSISTANTPATIENT ACCESS ASSISTANTGOOGLE ACCESS ASSISTANT CRXPROGRAM SUPPORT ASSISTANT GS 7 Submit time and expenses using this web-based application. To login, use the YourEncore username that is in the format: YOURENCORE CLINICAL DATA QUALITY REVIEWS Connect With Us. Follow us and get more great content. join us. Contribute to the success of our clients. Copyright © 2020 YourEncore. All rights reserved. SIGN IN - YOURENCORE connect with us. Follow us and explore more great content. join us. Join the YourEncore Expert Community. Expert Hub. Copyright © 2019 YourEncore. All rights reserved. YOURENCORE'S READYQMS Now more than ever, growing biopharmaceutical companies are feeling the crunch. In the face of a continuously evolving landscape, maintaining regulatory compliance, executing proper vendor oversight, and ensuring clinical development programs stay on track has becomeeven more critical.
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Our Subject Matter Experts. YourEncore Experts include a diverse mix of highly experienced, technical professionals from the Life Sciences industry. Our proven subject matter experts have the expertise and passion to create, innovate, and contribute to the success of ourclients.
YOURENCORE COVID-19 RESPONSE Since our founding over 16 years ago, YourEncore has been at the forefront of delivering bespoke, virtual teams of experienced industry experts to deliver outcomes-oriented solutions to our clients in the face of their most pressing challenges.REGULATORY ARCHIVES
Non-Alcoholic Steatohepatitis (NASH) is a specific metabolic disorder that manifests within the liver, possibly progressing to liver fibrosis and end-stage cirrhosis, as well as associating with an increased risk of cardiovascular (CV) morbidity & mortality and Type 2Diabetes.
ACCESS ASSISTANTACCESS ASSISTANT EXTENSIONACCESS ASSISTANT EXTENSIONLEVEL ACCESS ASSISTANTPATIENT ACCESS ASSISTANTGOOGLE ACCESS ASSISTANT CRXPROGRAM SUPPORT ASSISTANT GS 7 Submit time and expenses using this web-based application. To login, use the YourEncore username that is in the format: YOURENCORE CLINICAL DATA QUALITY REVIEWS Connect With Us. Follow us and get more great content. join us. Contribute to the success of our clients. Copyright © 2020 YourEncore. All rights reserved. SIGN IN - YOURENCORE connect with us. Follow us and explore more great content. join us. Join the YourEncore Expert Community. Expert Hub. Copyright © 2019 YourEncore. All rights reserved. YOURENCORE'S READYQMS Now more than ever, growing biopharmaceutical companies are feeling the crunch. In the face of a continuously evolving landscape, maintaining regulatory compliance, executing proper vendor oversight, and ensuring clinical development programs stay on track has becomeeven more critical.
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Developed and led by Liz Wool, Managing Expert with YourEncore’s Quality Center of Excellence, our team discusses the regulatory insights and practical guidance needed to modify and execute monitoring plans for remote monitoring in the COVID-19 era. EXPERT EXPERIENCE ARCHIVES LinkedIn continues to be one of the fastest growing B2B social media platforms, with over 500 million users. It allows you to build your personal brand, connect with professional contacts, and gain access to new and relevant content.CLINICAL ARCHIVES
Ilana Meskin, Managing Expert, YourEncore Clinical Center of Excellence, reviews M&A Culture within biopharma, the strides it has taken, and the peaks organizations have yet to reach. YOURENCORE'S READYQMS Now more than ever, growing biopharmaceutical companies are feeling the crunch. In the face of a continuously evolving landscape, maintaining regulatory compliance, executing proper vendor oversight, and ensuring clinical development programs stay on track has becomeeven more critical.
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Quality management used to be about completing checkbox audits, meeting compliance requirements, and reacting to problems. Today, pharmaceutical companies of all sizes are seeking to transform the way they manage quality to be more strategic and more proactive. YOURENCORE VIDEO CASE STUDY: VERO BIOTECH An innovative, growing biotech company, Vero Biotech, needed support getting through the challenging approval process for a complex drug/device combination.FREE WHITE PAPER
An effective advertising and promotion strategy is critical to the success of a product; but with a growing number of channels being utilized to reach providers and patients, maintaining regulatory compliance has become increasingly challenging.FREE WHITE PAPER
Vendor management and oversight is not only a regulatory imperative; it is a business imperative. Proper oversight is critical to ensuring patient safety, as well as mitigating the risks and financial implications of costly change orders, trial delays, non-productive clinical sites, rework (e.g. amendments), and data quality issues.CHANGE PASSWORD
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EXPERIENCE. AGILITY. RESULTS. From Strategy to Action. Solving Critical Business Challenges for the Life Science & Consumer Goods Industries.Our Solutions
EXPERIENCE. AGILITY. RESULTS. From Strategy to Action. Solving Critical Business Challenges for the Life Science & Consumer Goods Industries.Our Solutions
EXPERIENCE. AGILITY. RESULTS. From Strategy to Action. Solving Critical Business Challenges for the Life Science & Consumer Goods Industries.Our Solutions
EXPERIENCE. AGILITY. RESULTS. From Strategy to Action. Solving Critical Business Challenges for the Life Science & Consumer Goods Industries.Our Solutions
EXPERIENCE. AGILITY. RESULTS. From Strategy to Action. Solving Critical Business Challenges for the Life Science & Consumer Goods Industries.Our Solutions
EXPERIENCE. AGILITY. RESULTS. From Strategy to Action. Solving Critical Business Challenges for the Life Science & Consumer Goods Industries.Our Solutions
EXPERIENCE. AGILITY. RESULTS. From Strategy to Action. Solving Critical Business Challenges for the Life Science & Consumer Goods Industries.Our Solutions
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YourEncore was born from a passion to transform the way work gets done. We help forward thinking companies seize new opportunities and grow in the rapidly changing life sciences and consumer markets.WHY YOURENCORE?
We are pioneers in the consulting industry. We are industry leaders and experts with decades of business experience and deep technical mastery. From strategy to execution, we solve problems with speed. We understand your challenges. We get it… and we get it done. REAL INDUSTRY EXPERIENCE Battle-tested leaders. People who have built billion-dollar brands and brought breakthrough drugs to market.UNRIVALED EXPERTISE
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QUALITY IS NOT AN OPTION. IT IS A BUSINESS IMPERATIVE. * Proactively identify risks and navigate health authority inspections with confidence * Maintain and optimize your quality management systems * Conduct a broad range of GxP audits to identify and resolve issuesquickly
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WE COULD NOT HAVE REVIEWED THE SIGNIFICANT VOLUME OF DATA THAT NEEDED ASSESSMENT AS QUICKLY AS THE YOURENCORE TEAM. THEY DID AN EXEMPLARY JOB IN REVIEWING THE DATA AND IDENTIFYING THE RISK AREAS THAT WE NEED TO FOCUS ON MOST GOING FORWARD. Client's Director, Quality Process Lead ADVANCE APPROVALS. ANTICIPATE AND MITIGATE RISK. * Develop the strategy, build the roadmap and anticipate challenges so that you meet critical milestones with confidence * Operational support to effectively advance your regulatorystrategy
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THANKS TO YOURENCORE, WE WERE ABLE TO GET THE FLEXIBLE RESOURCES WE NEEDED AND CREATE HIGHER-QUALITY DELIVERABLES THAN WHAT WE WOULD HAVE EVER BEEN ABLE TO CREATE OURSELVES. THEY ALSO HELPED IDENTIFY ADDITIONAL AREAS OF IMPROVEMENT FOR OUR ORGANIZATION. Client's VP of Regulatory Affairs INNOVATION, OPTIMIZATION & REPEATABLE SUCCESS. * Drug and device development consulting – trusted independent expertise for critical assessments and guidance * Clinical trial oversight & remediation * Pharmacovigilance strategies that ensure compliance and patientsafety
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YOURENCORE’S TEAM WENT ABOVE AND BEYOND THE CALL OF DUTY. THE REPORT, INSIGHTS, AND RECOMMENDATIONS WERE EXTREMELY HELPFUL IN HELPING OUR TEAM DETERMINE THE BEST PATH FORWARD FOR THIS CRITICALASSET.
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OF THE TOP 30 GLOBAL PHARMA COMPANIESINSIGHTS
WEBINAR - REMOTE AUDITS IN THE COVID-19 ERAYourEncore Webinars
NASH: AN INTRODUCTION ON THE MOST SEVERE NON-ALCOHOLIC FATTY LIVERDISEASE
Brian Harvey
HOW THE GLOBAL PANDEMIC ACTS AS A CATALYST FOR TRANSFORMATIONIlana Meskin
DEVELOPING A DATA STRATEGY FOR CLINICAL TRIALSHugh Donovan
RAPS WEBCAST – THE SHIFTING GLOBAL REGULATORY LANDSCAPEYourEncore Webinars
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