Webinar Presents Practical Tips for Minimizing Timelines, Risk and Costs in Reproductive Health Studies
Women’s Health Specialty CRO Health Decisions to Assist Developers in Expediting Products for Women’s Unmet Medical Needs
Durham, North Carolina. Health Decisions, Inc., the full-service clinical research organization of choice for forward-looking biopharma and medical device companies and a leader in women’s health and diagnostics studies, today announced a webinar for reproductive health developers to be hosted by Xtalks on Wednesday, January 24, 2018. The webinar is entitled “Critical Success Factors in Reproductive Health Studies: Practical Tips for Minimizing Timelines, Risk and Costs.” Developers are invited to register for the complimentary webinar.
“As a women’s health specialty CRO, Health Decisions is starting the New Year with a webinar to assist developers in efficiently delivering products to improve healthcare outcomes in reproductive health indications,” stated Health Decisions CEO Patrick Phillips, BSc (Hons), D.Phil. “Our goal is to assist sponsors in making optimal use of their development resources to address significant unmet medical needs in women’s reproductive lives.”
The webinar 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.
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, a critical indication for management of women’s reproductive lives that affects quality-of-life throughout the reproductive years. Health Decisions’ experts 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.
About Health Decisions
Health Decisions is a full-service CRO offering therapeutic, operational and regulatory excellence for clinical development of drugs, diagnostics, medical devices and combination drug/devices in all areas of women’s health. Based on therapeutic and operational experience and investigator relationships developed in studies conducted over the past 28 years, Health Decisions successfully addresses the challenges of developing diagnostics in all therapeutic areas and drugs and devices in areas including reproductive and sexual health, menopause, pain management, osteoporosis/osteoarthritis, reproductive psychiatry, gynecologic oncology and general gynecology indications. Health Decisions is headquartered in Durham, NC.
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Senior Marketing Specialist
+1 919.967.1111 ext. 520
lhammill @ healthdec.com
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