A Proven Dual-Focus Specialty CRO for Women’s Health and Diagnostics
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 28 years ago, conducting more than 100 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.
The CRO of Choice for Products that Address Any Aspect of Women’s Health
In the last two years, Health Decisions has redoubled its commitment to women’s health and expanded its therapeutic scope with the declaration “If it matters to women’s health, it matters to Health Decisions.” Accordingly, Health Decisions has articulated a strategy and allocated resources to conduct studies of novel therapeutics for health conditions beyond traditional ObGyn indications to encompass the full range of women’s health concerns throughout the lifecycle. Thus, Health Decisions provides clinical development services not only for novel products for women-only health indications, but also for indications that affect women disproportionately or profoundly. Such indications include osteoporosis, autoimmune diseases such as multiple sclerosis and lupus and neuroscience indications such as depression and anxiety.
Outstanding Capabilities for Diagnostics Development in All Therapeutic Areas
Health Decisions is equally committed to clinical development of diagnostics for indications across the therapeutic spectrum. With precision medicine playing an ever-increasing role in healthcare, including but not limited to oncology and women’s indications, expertise in diagnostics will play an increasingly important role in conducting clinical studies. Diagnostics results already identify potentially responsive patients for many new therapeutics and determine patient eligibility for many clinical studies, especially in oncology indications. Molecular diagnostics will also play an increasing role in assessing the efficacy and safety of new drugs. Health Decisions is and will remain committed to providing services for the development of novel diagnostics in oncology, women’s health, infectious disease and other therapeutic areas.
Health Decisions provides sponsors with Global Agility through our Agile Global Alliance, which achieves extraordinary efficiency and unprecedented results for biopharma and device companies worldwide. Global Agility means optimal site selection and staff expertise for each study — right countries, right therapeutically aligned staff, right approach.
subject IVD study
faster than study of a competing product started in same timeframe
Working closely with a forward-looking sponsor, Health Decisions completed a 4,000- subject study of a novel HPV diagnostic two years ahead of a large competitor while reducing costs by 80%. As a result, the product generated $600 M in extra revenues and provided earlier diagnosis and better outcomes for tens of thousands of women worldwide. View the case study of an HPV diagnostic trial.
in additional revenues for biopharma sponsor of global oncology study
We helped a young biopharma company bring a novel therapeutic for metastatic breast cancer to market a year early. We completed enrollment rapidly in this challenging area through a tiered global enrollment strategy involving sites in Canada, Russia and the UK. We also reduced development costs through the adaptive design technique of sample-size reestimation. The successful study provided millions of women with earlier access to more effective treatment. View the case study of a metastatic breast cancer trial.
for neurosciences sponsor by terminating a futile study early, enabling refocus on a responsive subpopulation
We helped an innovative pharma company by providing timely access to interim efficacy data, enabling early termination and preventing futile expenditures of $2 M. We also provided data that enabled the sponsor to identify a responsive subpopulation and refocus the program with improved prospects for success in a follow-on study. View the case study of a Health Decisions trial in another neurosciences indication.
ahead of schedule in global phase III study
We enrolled the largest global contraceptive study of its kind a year ahead of schedule, helping a sponsor take an important step toward providing women around the world with greater contraceptive choice through a nonhormonal alternative. Health Decisions enrolled the study at a rate of 125 subjects per month compared to 30-38 subjects per month for previous similar studies. View a press release on completing enrollment early in a 3,400-subject global contraceptive trial.
Communication and Clarity
The level of interaction and communication and the clarity of discussion about who should do what and when were excellent. So were the business-oriented discussions that benefited both us and Health Decisions.
Global Project Leader
Instrumental in FDA Approval
It is so exciting to report that yesterday afternoon we received FDA APPROVAL for the combination program!!! You were instrumental in helping make the amendments to the protocol that the FDA requested within a day’s notice. Kudos!!!! Your team at Health Decisions has been wonderful and so responsive throughout this whole process. I cannot thank you enough!
Operational Excellence & Quality
I liked the day-to-day interaction with the excellent project manager and all the team members, the quality of the CRAs and their visit reports and time from LPLV to DB Lock given the complexity of the study and the excellent quality of the final database.
Clinical Research Manager