Health Decisions provides all the services of a traditional CRO and more – that is why we are a CRO+. We meet the development needs of biopharma and medical device companies worldwide. Fueled by insight and agility, services include managing individual phase I-IV trials of drugs and biologics; managing 510(k), PMA and CE Mark trials of medical devices; consulting on projects involving trial planning, design and biostatistics; and serving as a full-service virtual development arm – planning, managing and executing entire programs. More than 25 years of experience working with sponsors and regulators enables Health Decisions to identify optimal solutions for clinical-stage biopharma and device companies. LiveTrial technology powers a trial-management approach that leads the industry.

Drug and biologics trials

Health Decisions conducts highly efficient studies in all phases and many indications for both small-molecule drugs and biologics. Core therapeutic areas include women’s health and reproductive health, CNS, nephrology, infectious disease, oncology, and vaccines. View information on drug and biologics trials.

Medical device trials

Health Decisions has experience conducting efficient and successful trials of a variety of diagnostics, therapeutic and surgical devices and combination products. Large subject-based IVD studies are a specialty aided by sample tracking integrated in our LiveTrial CTMS. View information on medical device trials.

Project consulting

In addition to strategic consulting on the program level, our senior experts consult on study design, biometrics and operational planning for a variety of projects, utilizing adaptive techniques when appropriate and consistent with sponsor preference. View information on project consulting services.

Strategic development

Health Decisions serves as an expert and efficient virtual development arm enabling forward-looking companies to achieve striking successes without the time and cost involved in building comprehensive internal capabilities. View information on strategic development services.