Health Decisions is hosting a complimentary webinar, “Critical Success Factors in Reproductive Health Studies: Practical Tips for Minimizing Timelines, Risk and Costs.” The webinar will be held January 24, 2018. Reproductive health developers are invited to register for the complimentary webinar.
The webinar will address the challenges of conducting reproductive health studies efficiently while also generating high-quality data to support successful regulatory submissions. Topics will include:
- Recruitment, including factors such as utilizing advocacy groups and defining inclusion/exclusion criteria with care
- The importance of 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.
The 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, an indication that affects women’s quality-of-life throughout the reproductive years. Lessons drawn from studies in these indications will be broadly applicable in reproductive health studies.
The speakers combine extensive therapeutic, biostatistical, regulatory and operational experience and expertise in reproductive health studies.
- Andrea S. Lukes, MD, MHSc, FACOG, Chief Medical Officer of Health Decisions, will draw on experience as a principal investigator in more than 80 women’s health studies and as an advisor to many sponsors to discuss therapeutic considerations in reproductive health studies.
- Clint Dart, MS, Head of Data Services at Health Decisions, has more than 15 years of experience as a biostatistician in reproductive health studies and will discuss regulatory, design and operational considerations.
- Kevin Bickford, Head of Clinical Operations at Health Decisions and an operational executive with more than 20 years of experience in clinical research, will describe techniques for accelerated start-up refined in a variety of reproductive health studies, citing examples from a registration study of a therapeutic for bacterial vaginosis.
Health Decisions anticipates a lively Q&A session following presentations. Speakers will be prepared to answer questions about studies in the full spectrum of reproductive health indications.