Durham, North Carolina and Sofia, Bulgaria. Health Decisions, Inc., the leading US full-service women’s health specialty CRO and Comac Medical, a full-service CRO/SMO operating in 24 European countries, today announced an expansion of their strategic alliance to conduct women’s health clinical trials in the United States, Western and Central and Eastern Europe.
“Health Decisions is pleased to strengthen its strategic women’s health alliance with our colleagues at Comac Medical,” stated Health Decisions’ Chief Executive Officer Patrick Phillips, BSc (Hons), D.Phil. “The Health Decisions/Comac Medical alliance provides sponsors of women’s health trials with extensive therapeutic and operational expertise and access to hundreds of investigational women’s health sites in the United States and Europe. These regions provide care for hundreds of millions of women and generate approximately two-thirds of the revenues of the global biopharmaceutical industry. This strategic alliance will enable Health Decisions to fulfill its mission of improving healthcare outcomes for women worldwide and assisting sponsors who share that goal.”
“Comac Medical is delighted at the expansion of our strategic alliance with Health Decisions for the conduct of clinical trials in women’s health,” stated Milen Vrabevski, MD, Comac’s founder and Chief Executive Officer. “Our strategic alliance provides US and European biopharma companies with comprehensive clinical development services for women’s health products in Europe and the US. These regions offer advanced regulatory environments and both the funding and the investigational sites for most of the world’s clinical trials.”
Benefits of the Health Decisions-Comac Strategic Alliance for Women’s Health Trials
Drs. Phillips and Vrabevski summarized the benefits of the Health Decisions-Comac Medical strategic alliance as follows:
- Provides unrivalled therapeutic and operational capabilities to better enable our clients to deliver medicines of value in a wide range of areas related to Women’s Health
- Provides global access to Key Opinion Leaders and a site network of outstanding investigational sites in both the US and Europe.
- Will provide women who want to participate in clinical trials with broader access to experimental medicines across key areas of need
- Provides benefits to clients who need to perform global Phase 2 and 3 trials but who are also looking to partner with a specialty full service CRO focused in the Women’s Health arena
- Provides services for phase 1-4 clinical trials in both OB/GYN indications and high-female-prevalence indications like osteoporosis, migraine and immune-mediated disorders
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 drugs and devices in areas including reproductive and sexual health, menopause, pain management, osteoporosis/osteoarthritis, reproductive psychiatry, and gynecologic oncology. In addition, Health Decisions conducts studies of diagnostics in women’s health and related areas, including oncology and infectious disease. Health Decisions is headquartered in Durham, NC.
About Comac Medical
Comac Medical is a full-service, boutique CRO/ SMO operating in 24 European countries offering clinical development in early phases in own University-based Clinical Pharmacology Unit, as well as excellence in late phase trials of medications and medical devices. Through a network of Key Opinion Leaders and dedicated healthcare institutions, Comac Medical has been managing and monitoring clinical studies in all therapeutic areas (oncology, cardiology, respiratory, rheumatology, renal and hepatic, vaccines, etc.) throughout Europe for the last 20 years. Comac Medical has strong Biometrics and Bioanalytical capabilities adding value to its full-service expertise. The unique relationship with Academia in research and development of innovative products has resulted in winning a Horizon 2020 grant and a recognition of Comac Medical by the European Commission as an innovative company. Comac Medical is based in Sofia, Bulgaria.
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