Topic: About Us

Differences Between Drug and Medical Device Trials: CSRs

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… Read more »

Thinking of Women’s Healthcare Needs on International Women’s Day

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… Read more »

2017 – Time for a Bold R&D Initiative in Women’s Health

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… Read more »

ASRM-NICHD Workshop Focuses on Expanding Access to ART

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… Read more »

Health Decisions to Exhibit and Present at DIA 2016

On the eve of the 2016 Drug Industry Association 52nd Annual Meeting in Philadephia June 26-30, the Health Decisions event team is looking forward to lively discussions of clinical development issues in booth #1143, a busy calendar of meetings with current and prospective clients and leading a forum on one of the hottest issues in… Read more »

Women’s Health Week: Highlighting Unmet Medical Needs

Significant unmet medical needs profoundly affect the lives of hundreds of millions of women worldwide. Women have more than their fair share of healthcare needs for a variety of reasons, including: Women’s healthcare needs vary substantially over the life cycle, from childhood and adolescence through the childbearing years and menopause; this increases the challenge for… Read more »

Precision Medicine White Paper Goes Live in Busy Week for the Precision Medicine Initiative

With the White House hosting a Precision Medicine Initiative Summit and National Institutes of Health Director Francis Collins announcing plans to enroll 79,000 volunteers this year in the PMI Cohort Program, there can be little doubt that precision medicine is gaining momentum on the national and global scene. Health Decisions has been increasingly active in… Read more »