Health Decisions is a full-service specialty CRO and more – that is why we are a CRO+. We are the clinical development partner of choice for forward-looking biopharma, diagnostics, precision medicine and medical device companies worldwide. We use data-driven insight and agility to deliver clinical development success, enabling companies to bring products to market earlier and with less risk. Health Decisions’ comprehensive Agile Clinical Development methodology, enabled by proprietary LiveTrial technology, combines with deep development insight and expertise to provide excellence in every aspect of clinical research. Health Decisions headquarters is located in Durham, North Carolina.
To deliver superior clinical research solutions and services to biopharma, diagnostics, precision medicine and medical device companies through continuous innovation that reduces risk and time to market, fails unsuccessful products faster, enables cost-effective development of precision medicines and provides millions of people around the world with earlier and more affordable access to novel therapeutics and medical devices.
Leading the Way to Precision Medicine and a More Efficient Future
For more than 27 years and more than 300 studies, Health Decisions has improved the efficiency of clinical development through innovative, award-winning methodology, processes and technology. Health Decisions continues to lead the way through our work with innovative sponsors, thought-provoking proposals such as our white paper on replacing phase 3 clinical trials with a novel phase 2c approach, membership in the Personalized Medicine Coalition and recognition by independent observers. Health Decisions’ recent awards include being named Best CRO in the Triangle Business Journal 2015 Life Sciences Awards, the 2014 Award for Innovation in Clinical Research from the Association of Clinical Research Professionals and the 2013 CIO 100 Award from CIO Magazine for Health Decisions’ risk-based monitoring approach. Health Decisions’ firsts include being the first to use unmonitored data for trial management, the first to collect data as source at both field and patient level and the first to have an adaptive design approved by FDA’s oncology group. Health Decisions is hard at work creating more clinical development firsts. We provide world-class training and career development and encourage employees to recommend process improvements. We reward those who advance the most promising ideas. Look for Health Decisions to lead the way in risk-based monitoring, predictive analytics, collection of trial data in patient homes and many other areas with the potential to improve efficiency. View more information about Health Decisions’ history and awards.
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. View more information on Health Decisions’ global reach.
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