Health Decisions and Comac Medical Strengthen Strategic Alliance for Women’s Health Trials 2018-08-22T18:31:27-05:00

Project Description

US CRO Health Decisions and European CRO/SMO Comac Medical Expand Transatlantic Collaboration in Women’s Health

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, Europe and spanning the two regions.

“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

HD Comac Women's Health Strategic AllianceDrs. Phillips and Vrabeski summarized the benefits of the Health Decisions-Comac Limited strategic alliance as follows:

  • Extensive therapeutic and operational expertise in women’s health clinical trials at both Health Decisions and Comac
  • Access to Key Opinion Leaders and hundreds of investigational sites and Principal Investigators in women’s health in both the US and Europe
  • Comprehensive clinical development services throughout the world’s two largest markets for biopharmaceutical products, including:
    • Project management
    • Capabilities for phase 1 – 4 clinical trials
    • Site management and monitoring
    • Biostatistical services
    • Study design and protocol development
    • Regulatory services
  • Services for phase 1-4 clinical trials in both OB/GYN indications and high-female-prevalence indications like osteoporosis, migraine and immune-mediated disorders
  • Expert advice on clinical development strategy for the US and Europe.

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, gynecologic oncology and general gynecology indications. In addition, Health Decisions conducts studies of diagnostics in women’s health as well as other therapeutic 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 its 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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