Press Release – updated: Jan 15, 2018 16:00 EST
TORONTO, January 15, 2018 – In an Xtalks webinar upcoming on Wednesday, Jan. 24, 2018, featured speakers from Health Decisions, a leading women’s health specialty CRO, will address the challenges of conducting reproductive health studies efficiently and generating high-quality data to support successful regulatory submissions.
Discussion topics include:
- Recruitment, with attention to the importance of factors such as utilizing advocacy groups and defining inclusion/exclusion criteria with care
- The importance of fully understanding and addressing the therapeutic, operational and design implications of FDA requirements for each reproductive health indication
- Proven methods for achieving accelerated start-up in reproductive health studies
This webinar will draw on examples from studies in endometriosis, an OB/GYN indication that profoundly affects reproductive health; bacterial vaginosis, a common infectious condition that can contribute to infertility; and contraception, a critical indication for management of women’s reproductive lives that affects quality-of-life throughout the reproductive years.
The speakers from Health Decisions will present therapeutic and operational observations from studies in these specific indications, however, the operational solutions discussed will be applicable across the spectrum of reproductive health indications.
- Chief Medical Officer, Andrea S. Lukes, MD, MHSc, FACOG, will discuss therapeutic and design considerations for all three indications as well as recruitment considerations in endometriosis studies
- Head of Data Services, Clint Dart, MS, will discuss regulatory, design and operational considerations in studies of contraceptives
- Head of Clinical Operations, Kevin Bickford, will describe proven techniques for achieving accelerated start-up in reproductive health studies, with examples from a registration study of a therapeutic for bacterial vaginosis
For more information about this complimentary webinar, visit: Critical Success Factors in Reproductive Health Studies: Practical Tips for Minimizing Timelines, Risk and Costs
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