This webinar will explore how standardized endpoint definition in clinical trials is necessary to facilitate accurate evaluation and comparison of drugs across clinical trials as well as to identify early safety signals. To accomplish this, goals must be established in order to:
- Consistently, accurately and reproducibly capture clinical concepts and standardize the terminology used to describe diseases, events and procedures
- Establish a universal clinical vocabulary to serve as a foundation for clinical research with the ultimate goal of improving the assessment of process, performance, and outcomes across multiple dimensions of healthcare
Attendees will also learn industry best practices when choosing the right independent clinical endpoint adjudication committee. Selecting the right partner to perform objective endpoint reviews, supported by intuitive technology, directly correlates to clinical trial success.
Christian T. Ruff, MD, MPH, TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School
Christian T. Ruff, MD, MPH is currently the Director of General Cardiology in the Cardiovascular Division at Brigham and Women’s Hospital in Boston, MA and an Assistant Professor of Medicine at Harvard Medical School.
Dr. Ruff graduated from Harvard University, earned his medical degree at Johns Hopkins University School of Medicine, and his masters of public health from the Harvard School of Public Health. Dr. Ruff completed his internal medicine residency and cardiovascular medicine fellowship at the Brigham and Women’s Hospital.
Dr. Ruff is an investigator in the Thrombolysis in Myocardial Infarction (TIMI) Study Group and serves as the Director of the Genetics Core Laboratory and the Co-Chairman of the Clinical Events Committee. He has led a broad array of projects, ranging from investigator-initiated studies of biomarkers and genetic variants to large clinical trials. Dr. Ruff has investigated the efficacy and safety of antithrombotic therapies across the spectrum of cardiovascular disease, with a focus on stroke prevention in atrial fibrillation. He also has an interest in developing innovative computational and bioinformatic strategies to identify important relationships across genes, proteins, and compounds.
Dr. Ruff has served on international clinical guideline committees and has been invited to give hundreds of lectures nationally and internationally. He has authored many scholarly articles, editorials, reviews, and book chapters that include the New England Journal of Medicine, Lancet, Journal of the American Medical Association, American Journal of Medicine, Circulation, Journal of the American College of Cardiology, and Nature Reviews Cardiology.
Lisa Chwieroth, Director of Clinical Adjudication Services, Bioclinica
With more than 15 years of drug development industry experience, Lisa Chwieroth serves as the Director of Clinical Adjudication Services at Bioclinica. In this role, Ms. Chwieroth holds responsibility for the operational planning process to deliver CEC projects on schedule and on budget while also ensuring quality. Prior to joining Bioclinica, Ms. Chwieroth was with ICON Medical Imaging where she co-founded and led the Electronic Adjudication Services department. Her time at ICON also included roles of increasing responsibility in Clinical Operations and Project Management. Lisa initiated her career as a certified technologist in MRI and CT.
Who Should Attend?
- Chief Medical Officers
- Chief Safety Officers
- Safety Team Members
- Data Management Team Members
- Clinical Project Managers
- Endpoint/Event Adjudication Coordinators
- Director of Operations
- R&D Managers
- R&D Directors
What You Will Learn
Key goals when choosing the right independent clinical endpoint adjudication committee, including:
- Consistently, accurately and reproducibly capturing clinical concepts and standardizing the terminology used to describe diseases, events and procedures
- Establishing a universal clinical vocabulary to serve as a foundation for clinical research with the ultimate goal of improving the assessment of process, performance, and outcomes across multiple dimensions of healthcare
Bioclinica is a global life sciences solution provider that utilizes science and technology to bring clarity to clinical trials – helping companies to develop new life-improving therapies more efficiently and safely. Successful clinical trials require the ability to see key details and uncover hidden insights, and Bioclinica’s hundreds of experienced scientific, medical, and domain experts bring unmatched insight across the development lifecycle, from the initial protocol to post-approval. The company’s cloud-based offerings include medical imaging; cardiac safety; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site payments and forecasting; pharmacovigilance; trial management; and risk-based monitoring solutions. A true multifaceted partner to trial sponsors and Contract Research Organizations (CROs), Bioclinica offers an integrated App xChange partner ecosystem, a global network of research sites, patient recruitment services, and post-approval research expertise to provide committed, detail-focused service through all stages of drug development. The company’s thousands of employees serve more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 biopharmaceutical companies and leading CROs – through a network of offices in the U.S., Europe, and Asia.