Health Decisions is a full-service CRO specializing in clinical studies of therapeutics for women’s health indications and studies of diagnostics for all therapeutic areas. Health Decisions has focused on women’s health since its inception more than 29 years ago, conducting more than 140 trials in women-only indications such as contraception and postmenopausal vasomotor symptoms. More than a decade ago, Health Decisions expanded into diagnostics studies with a large PMA study of a screening test for high-risk HPV types – the precursors of cervical cancer. Building on the success of the HPV study, Health Decisions has conducted successful diagnostics studies in a variety of other indications in women’s health and beyond, including diagnostics for risk of preterm birth, STIs, a variety of respiratory indications and oncology indications such as colorectal cancer and urothelial carcinoma. Health Decisions has provided services enabling many developers of both women’s health products and diagnostics to meet their development and business goals and looks forward to successful collaborations with many more. They take pride in offering the flexibility to tailor services to each sponsor in a manner that builds on the strengths of both development partners.
Health Decisions provides efficient, high-quality clinical development services for sponsors of women’s health products as well as diagnostics and medical devices for all therapeutic areas. They have assisted sponsors in conducting many individual phase 1 – 4 clinical studies as well as in supporting programs from pre-IND and pre-IDE discussions through successful NDAs, PMAs and 510(k)s. They are committed to understanding each sponsor’s needs and preferences and tailoring their services accordingly. Their pledge is to embrace your development and business goals and serve as an extension of your project team.
Health Decisions offers comprehensive clinical development services for drug, diagnostics and medical device companies. They have successfully conducted full-service trials involving tens of thousands of patients at hundreds of investigational sites and resulting in successful NDAs, PMAs and 510(k)s. While Health Decisions generally provides full services for each clinical study, they pride theirselves on the flexibility to adapt their service offerings to the needs and preferences of each sponsor and project. Their experts have consulted on program planning, regulatory strategy and study design and have provided a variety of statistical services for developers of both drugs and diagnostics. In addition, they have served as a Functional Service Provider for data management, biostatistics and clinical monitoring. Their service offerings include trial management, monitoring, data management and biostatistics, regulatory and quality, and study design and protocol development