With increased attention on response to ICH E6 (R2) guidance and on achieving higher levels of transparency and speed, many pharmaceutical companies have begun to implement new CRO oversight practices and mechanisms. This webinar presents the results of a recent study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) that benchmarks CRO oversight practices and their impact and effectiveness.

Join Ken Getz of Tufts CSDD as he discusses the results of the study and their implications. Specific areas covered include:

Types of CRO oversight models used for the variety of outsourcing approaches utilized
Oversight challenges including transparency risk and compliance areas
Industry experience with different oversight models and their reported impact and effectiveness
Performance metrics being gathered to measure oversight effectiveness
Insights into new approaches being implemented and planned to improve oversight effectiveness

Speakers will also share where the industry is headed and ways to overcome oversight challenges including transparency, risk and compliance.

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Speakers

Julie Peacock, Client Services, Comprehend

Closely aligned with customers and the sales organization, Julie focuses on enabling prospects and customers on Comprehend’s Clinical Intelligence solutions. She manages go to market strategy, sales enablement, and product marketing.

Prior to Comprehend, Julie spent 18 years at Oracle Corporation in the enterprise application space where she managed strategy, field enablement and launch activities for a series of BtoB solutions. Julie holds a bachelor’s degree in Marketing from Auburn University.

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Ken Getz, Director of Sponsored Research Programs & Associate Professor, Tufts CSDD

Kenneth A. Getz is the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine where he directs research programs on drug development management strategy and practice including protocol design and execution; outsourcing; investigative site management; and patient recruitment and retention. He is the chair of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. Ken is also the founder of CenterWatch, a leading publisher in the clinical trials industry.

A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press. He is the author of two nationally recognized books for patients and their advocates and the recipient of several awards for innovation and scholarship. Ken has held board appointments in the private and public sectors including serving on the Institute of Medicine’s Clinical Research Roundtable, the Drug Information Association, the Consortium to Examine Clinical Research Ethics, the Clinical Trials Transformation Initiative, the Metrics Champion Consortium, and the WIRB-Copernicus Group. He is on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science, and writes a bi-monthly column in Applied Clinical Trials that was nominated for a Neal Award. Ken has also been nominated twice for Tufts University’s Distinguished Service award and was inducted as a DIA Fellow in 2015.

Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch in 1994, Ken worked for over seven years in management consulting where he assisted biopharmaceutical companies to develop and implement business strategies to improve clinical development performance.

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Who Should Attend?

CROs, Clinical Operations and Data Management Professionals

Clinical Trial/Clinical Study Management
Clinical Data/Informatics/IT
Clinical Outsourcing
Clinical Project Managers/Directors
Director of Project Delivery

Clinical Research, Technology and Business Professionals

Biometrics/Biostatistics
Business Technology/Applications/Solutions
Business Analyst
CTO
Project Management

Xtalks Partners

Comprehend

Comprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety and quality of a portfolio of clinical trials. Across studies, sites, systems and CROs, Comprehend’s Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight and collaboration, and medical monitoring initiatives. Comprehend gives life sciences companies a new source of competitiveness and the confidence to deliver high quality trial submissions at a new speed. Comprehend: The speed to quality results. Learn more at www.comprehend.com.

Tufts Center for the Study of Drug Development

The Tufts Center for the Study of Drug Development is an independent, academic, non-profit research group at Tufts University in Boston, Massachusetts. Its mission is to develop strategic information to help drug developers, regulators, and policymakers improve the quality and efficiency of pharmaceutical and biopharmaceutical development, review, and utilization.