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, diagnostics 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 diagnostics; planning, management and execution of precision- medicine projects; planning and conducting trials of therapeutic and surgical 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 27 years of experience working with sponsors and regulators enables Health Decisions to identify optimal solutions for clinical-stage biopharma, diagnostics, precision-medicine and device companies.
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 and reproductive health, endocrine and metabolism, CNS and infectious disease. View information on drug and biologics 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 diagnostics trials.
Health Decisions assists both drug and IVD companies with precision-medicine services, including trial management and execution, program planning and strategic advice concerning both therapeutic agents and diagnostics. In addition, Health Decisions applies the techniques of precision medicine to all studies. View information on precision medicine.
Medical device trials
Health Decisions has experience conducting efficient and successful trials of a variety of therapeutic and surgical devices and combination products, including carotid artery stents, endovascular stent grafts, combination drug/devices and contraceptive devices such as vaginal rings and barrier contraceptives. View information on medical device trials.
Health Decisions’ senior experts provide strategic advice and planning, enabling sponsors to reduce risk and timelines for their development programs. Health Decisions is also proficient at serving as a full-service virtual development arm if sponsors prefer that approach. View information on strategic development services.
Health Decisions senior experts and biostatisticians provide comprehensive consulting services on program planning, trial design, biostatistical analysis, and operational considerations in development of drugs, diagnostics, precision medicines, medical devices and combination drug-devices. View information on consulting services.