Partnerships drive biopharma development today more than ever, especially in clinical development. The scope of partnerships ranges from contracts to conduct individual studies to functional-service-provider arrangements or outsourcing agreements encompassing whole development programs and sometimes even the whole of a company's clinical development activity. While clinical development partnerships are commonplace, they are seldom simple. Forming [...]
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The BIO International Convention convenes June 4 in Boston, MA. The City-on-a-Hill is an excellent setting for BIO for reasons including its role as a hotbed of both academic and commercial development. As a women’s health specialty CRO, Health Decisions sees another reason to appreciate Boston as a venue for BIO: the city’s history of [...]
Health Decisions recognizes the importance of increasing the participation of women in clinical trials in order to identify differences in female response, provide female-specific prescribing information and reduce the number of adverse events experienced by women taking approved medications. Based on Health Decisions' extensive experience as a women's health specialty CRO, Project Manager Jessica Kappes, [...]
Health Decisions' Chief Medical Officer Andrea Lukes, MD, MHSc, FACOG As Health Decisions celebrates National Women’s Health Week (NWHW), we decided to sit down with our Chief Medical Officer, Andrea S. Lukes, MD, MHSc, FACOG, a practicing OB/GYN and active Principal Investigator as well as a CMO, to ask her thoughts on NWHW, key health [...]
A post in this blog during National Women's Health Week 2016 discussed six areas of significant unmet medical needs in women's health. This post for National Women's Health Week 2018 provides an update on the status of product development in addressing three of those areas of unmet need. Increased availability of noninvasive diagnostics for health conditions [...]
The Health Decisions team attending ACOG 2018 - the Annual Clinical and Scientific Meeting in Austin April 27-30 - had a busy, enjoyable and productive week with our colleagues in the OB/GYN community. In keeping with its mission as a women's health specialty CRO, Health Decisions sponsored and participated in the 5K Run/Walk for Women. [...]
Meeting planned enrollment timelines is a challenge in many clinical trials. Studies of novel products for treatment and diagnosis of women's health conditions are no exception. Based on years of experience in women's health clinical trials, the Health Decisions Clinical Affairs group has developed a methodology that has successfully accelerated start-up in studies in a [...]
March is Endometriosis Awareness Month, a reminder of the importance of ensuring that clinical development of novel endometriosis treatments progresses as rapidly as possible. This is an area of significant unmet medical need affecting approximately 10% of women of reproductive age worldwide – approximately 176 million women. While sometimes asymptomatic, endometriosis is often associated with infertility [...]
Women and their OB/GYNs can select from an enormous variety of contraceptive products today. This includes multiple categories of contraceptives - oral contraceptives, implants, intrauterine devices (IUDs) or systems (IUSs), injectables, patches, rings, diaphragms and spermicides. Within categories there is usually a choice of multiple products. With contraceptives already available in such variety, it would [...]
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 [...]