Progress in male contraception, including male hormonal contraception, has captured the attention of mainstream media, as demonstrated by an article in the June 18 issue of Time Magazine, "This Man Wants to Be on Birth Control: Inside the race to develop a better male contraceptive." (Subscription required.) Author Alexandra Sifferlin has provided an excellent overview of the field [...]
Health Decisions was pleased to participate in the 2018 HealthyWomen dinner, held at the Italian Embassy in Washington June 13, where the theme was "'Alla Nostra Salute! To Our Health' - Celebrating innovation that advances women's health research and advocacy for future generations." HealthyWomen is an independent nonprofit organization addressing one of many underserved needs in [...]
Health Decisions CEO, Patrick Phillips, BSc (Hons), D.Phil., attended BIO 2018 in Boston to meet with companies active in development of new therapeutic and diagnostic products to improve healthcare outcomes for women. After the conference, Dr. Phillips offered observations on a variety of trends in evidence at the conference and on Boston as a conference [...]
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 [...]
As a leading women’s health clinical research organization (CRO), Health Decisions joins the World Health Organization and others in celebrating World Contraception Day. We view this as an occasion to recognize the progress in contraception made since the introduction of the first oral contraceptive and the first intrauterine device (IUD) in the United States almost [...]
Social media are useful recruitment tools but results vary, especially as to the quality of subjects. Examples from two recent Health Decisions trials illustrate. We utilized a variety of social media in both trials, including craigslist, Facebook, a social media recruitment vendor's sites and investigators' social media sites. In one study, social media accounted for [...]
While drugs and medical devices are both essential in modern medical care, there are times when standard clinical development processes seem to treat medical devices as an afterthought. For example, medical writers for a CRO conducting studies of both drugs and devices must learn to interpret a drug-centric guidance document to author an appropriate Clinical [...]
As a CRO focused on clinical development of products to improve women's healthcare, Health Decisions sees International Women's Day as an occasion to redouble our commitment to enabling drug, diagnostics and medical device companies to bring new women's health products to market as rapidly and efficiently as possible. For Health Decisions, the scope of women's [...]
Despite NIH and FDA women's health policy initiatives previously described in this blog, the list of novel drugs approved by FDA in 2016 includes only one product for a woman-specific health indication. FDA granted accelerated approval in December 2016 for rucaparib (Rubraca™), a Clovis Oncology PARP inhibitor for ovarian cancer. Rubraca is indicated for patients [...]
The 2016 Scientific Congress of the American Society for Reproductive Medicine (ASRM) is in full swing in Salt Lake City. Among the events of greatest interest to the Health Decisions contingent at the congress is "Advancing Science and Practice to Improve Access in Reproductive Care," a workshop jointly sponsored by ASRM and the Eunice Kennedy [...]
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