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Theorem’s Webinar Offers Strategies to Improve Clinical Endpoint Adjudication
(King of Prussia, PA; Sept. 2, 2015) — Theorem, a leading global contract research organization (CRO) that optimizes trial conduct, will explore the clinical endpoint committee (CEC) process in the webinar, “Clinical Endpoint Adjudication: Strategies to Improve CEC Process Flow and Accurate Endpoint Review,” on Sept. 22 at 10 a.m. (ET).
Lisa Moore, PhD, RN, Theorem senior director, scientific affairs, will discuss how to run a successful CEC, mitigate risks to adjudication and put the best processes in place to decrease time and provide cost efficiency. Richard H. Patt, MD, principal and cofounder of RadMD and BRITI, will also provide insight on the incorporation of medical imaging into clinical development and endpoint review.
“The FDA is increasingly requiring high-risk clinical trials to involve clinical endpoint committees,” said Moore. “When time and money are on the line, it’s important to have a committee in place that ensures best practice, and one the FDA will have confidence in.”
Moore will speak on the importance of early planning, how to examine who the stakeholders in the adjudication process are, and methods to identify common pitfalls to successful adjudication and streamline the process to ensure quality review for successful analysis and submissions. She will also provide lessons she has learned from her years of CEC experience at Theorem.
The webinar will benefit any leaders at CRO, biopharmaceutical or pharmaceutical companies who are involved in CEC coordination, project or data management, biometrics, biostatistics, safety or pharmacovigilance, clinical or medical monitoring, clinical operations or therapeutic leadership.
Moore has more than 25 years of industry experience, including almost a decade of experience in the coordination and management of CECs and data safety monitoring boards (DSMBs). Patt is a member of the FDA/industry Pharma Imaging Group and was course codirector of the 2010 symposium “Imaging in Cancer Trials.”
To learn more and register for the event, visit TheoremWebinar.com.
About Theorem
Theorem Clinical Research Inc. is a global provider of comprehensive clinical services with staff throughout the Americas, Europe and Asia-Pacific and a client base comprised of the world’s leading biopharmaceutical and medical device companies. With industry-leading experts, unparalleled therapeutic expertise and innovative, groundbreaking technology, Theorem is focused on analytic-based development, combination trials and personal data applications to simplify complex trials.
About RadMD
RadMD is the global leader in providing medical imaging expertise for clinical trials. Founded by Drs. Richard Patt and Kohkan Shamsi, both radiologists, who each bring over 20 years of pharmaceutical clinical development, regulatory, and imaging experience. RadMD’s expertise is focused on developing clinico-regulatory compliant strategies to implement imaging efficacy and safety endpoints in trials from Phase 1 (e.g., improving go/no-go decision making) through Phase 4 (e.g., imaging-enabled registries). With an international network of over 600 trained and certified independent image and clinical reviewers, including radiologists, oncologists, cardiologists, pathologists, gastroenterologists, dermatologists, and other specialized physicians, RadMD experts provide additional world-class expertise.