Health Decisions' Therapeutic Expertise
Health Decisions’ 20+ years of experience spans more than 300 clinical studies in Phases I – IV, including global studies, registration studies, 510(k) clearances, and Premarket Approval Applications (PMAs), as well as helping companies pursue the optimal path to CE Mark in Europe. The Health Decisions team has developed an approach to clinical trials that combines the latest design techniques and operational processes to maximize the efficiency of clinical studies across a wide range of therapeutic areas.
Health Decisions' Core Strengths
Women’s Health
Health Decisions has designed and conducted studies in women’s health for more than 20 years and has served as Clinical and Statistical Coordinating Center for Contraceptive Research for the National Institute of Child Health & Human Development for 15 years. Health Decisions has deep expertise in the therapeutic, statistical, and operational aspects of women’s health studies in areas including contraceptives, postmenopausal HRT, HPV, dysmenorrhea, amenorrhea, vaginitis, endometriosis, osteoporosis, pain management following hysterectomy, and metastatic breast cancer. Learn More >
In-Vitro Diagnostics, Surgical and Therapeutic Devices
Health Decisions’ In-Vitro Diagnostic (IVD) expertise is particularly profound in subject-based studies of molecular diagnostics and includes experience with biochemical diagnostics, ELISA tests, combination biochemical and electrochemical diagnostics, companion diagnostics, multi-parameter automated analyzers, IVD multivariate index assays, and traditional diagnostics such as ESRs. Health Decisions conducted the gold-standard subject-based study in molecular HPV diagnostics. In addition to studies of IVDs, Health Decisions has conducted studies of surgical and therapeutic devices, including endovascular stents.
Vaccines
Health Decisions has experience with studies of both prophylactic and therapeutic vaccines. Our experience includes studies of a variety of influenza vaccines and vaccines for nasopharyngeal colonization by streptococcus pneumonmiae and renal cell carcinoma. Health Decisions enables sponsors to meet challenging enrollment timelines in vaccine studies by providing real-time access to reactogenicity data, as well as the opportunity to use electronic source documents for reduced monitoring. The result is lower source-data verification costs and faster site closeout and database lock. Learn More >
Oncology
Health Decisions has deep and strong clinical oncology experience, including studies of biologics, immunotherapeutics and complex autologous products. Our oncology experience includes studies of treatments for colorectal cancer, solid tumors, malignant melanoma, metastatic breast cancer, gastrointestinal cancer, advanced renal cell carcinoma, relapsed or refractory solid tumors, leukemia, prostate cancer, prostatic intraepithelial neoplasia, and squamous cell carcinoma of the head and neck. Health Decisions also has experience with preventative oncology therapeutics including prostate cancer prevention. Learn More >
CNS
Health Decisions has completed CNS studies focusing on Alzheimer’s disease, depression, severe brain trauma, mild cognitive impairment, multiple sclerosis, autism, fragile x syndrome, methamphetamine dependence, cocaine dependence and stroke. Extensive experience with subjective assessments, where inadequate attention to variability issues can increase sample-size requirements and costs, has enabled Health Decisions to minimize risk of delays and cost overruns in many CNS studies. Besides offering EDC, Health Decisions provides SmartPen data-capture for real-time data access, especially valuable in CNS studies with rapid patient response and Visual Analog Scales (VAS). Learn More >
Nephrology
Health Decisions has conducted a variety of nephrology studies involving chronic kidney disease (CKD) stage 5 CKD and renal cell carcinoma. Health Decisions has extensive expertise partnering with major hemodialysis SMOs, facilitating strategic site selection and ensuring consistency in training for site staff, contracts and regulatory management. Our experienced nephrology PMs and CRAs understand the challenges of working with dialysis subjects and in the dialysis setting, where reimbursement rates typically make site budgets tight. Health Decisions conducts nephrology studies with great efficiency whether they involve a few sites with 20-30 subjects or dozens of sites with hundreds of subjects. Learn More >