Over 25 years and 300 trials, Health Decisions has developed expertise in a wide range of therapeutic areas and a variety of device categories, with particular strength in several core areas. Health Decisions has successfully completed projects in many indications for many sponsors. Health Decisions effectively manages individual phase I-IV trials of drugs and biologics or 510(k) and PMA device studies, consults on design and biometrics or serves as sponsors’ virtual clinical development department. Our experience enables us to identify optimal solutions for clinical programs, trials and projects across the spectrum of therapeutic agents and for therapeutic, diagnostic and surgical devices.
Our expertise includes but is not limited to the following therapeutic areas and device categories:
- Women’s Health
- Endocrinology and Metabolism
- Infectious Disease
- Diagnostic Devices inc. IVDs
- Implantable Devices
- Molecular Diagnostics
- Therapeutic Devices
- Surgical Devices
- Combination Drug-Devices
- Contraceptive Devices
Reproductive and Women’s Health
For more than 25 years, Health Decisions has designed and conducted studies in a variety of women’s health indications for commercial sponsors and other institutions, supporting a number of successful NDAs for reproductive and women’s health products. Experience includes contraceptives, postmenopausal HRT, HPV, dysmenorrhea, amenorrhea, vaginitis, endometriosis, osteoporosis, pain management following hysterectomy, and metastatic breast cancer. In addition, Health Decisions has since 1996 served as Clinical and Statistical Coordinating Center for Contraceptive Research for the National Institute of Child Health & Human Development. View additional information on Health Decisions’ expertise in reproductive and women’s health.
Endocrinology and Metabolism
The Health Decisions endocrine and metabolism team includes a board-certified endocrinologist and our staff experience and expertise include therapeutic, biostatistical and operational capabilities at all levels of responsibility, including executive oversight, project management, site operations and site monitoring. We have extensive relationships with investigational sites, Principal Investigators and Key Opinion Leaders. We understand the challenges of recruitment and retention in a therapeutic area with frequent clinical trials in major indications. Experience includes phase I-IV clinical trials.
View additional information on Health Decisions’ endocrinology and metabolism expertise.
Health Decisions has conducted successful, efficient IVD trials in a variety of indications and types of IVDs, including molecular diagnostics, immunoassays and others. Our IVD development services offer the design and operational excellence and regulatory expertise required to develop IVDs successfully and eliminate risk of delays in the 510(k) clearance or PMA review process. Health Decisions’ capabilities for helping diagnostics companies make rapid, successful transitions from early sample-collection and validation studies to large subject-based studies are unmatched. Experience includes a conducting trials of oncology, infectious disease and reproductive health diagnostics. Download a fact sheet on Health Decisions capabilities in diagnostics studies.
Health Decisions has completed Neurosciences studies focusing on ADHD, Alzheimer’s disease, depression, severe brain trauma, mild cognitive impairment, multiple sclerosis, autism, fragile x syndrome, methamphetamine dependence, cocaine dependence, stroke and pain management. Extensive experience with addressing issues such as placebo effect and variability in subjective assessments, where inadequate attention can increase sample-size requirements and costs, has enabled Health Decisions to minimize risk of delays and prevent cost overruns in many neurosciences studies. Health Decisions has experience with use of e-source assessments and central review to reduce variability in neurosciences assessment data. View additional information on Health Decisions’ neurosciences expertise.
Health Decisions has extensive and growing experience with infectious disease studies, including studies of both therapeutic agents and diagnostics. Experience with indications includes bacteremia, chlamydia and gonorrhea, HPV, clostridium difficile, hepatitis C, HIV, influenza, MRSA, respiratory viruses, sepsis and skin and soft tissue infections. Health Decisions’ activities in infectious disease include providing clinical research and support services for clinical trials in a broad range of indications and in all phases. View additional information on Health Decisions’ infectious disease expertise.
Health Decisions assists developers of therapeutic, surgical and combination drug/devices in design and conduct of clinical trials to demonstrate safety and efficacy. Our experience includes trials of carotid artery stents, endovascular stent grafts, a stent graft in arteriovenous graft for hemodialysis, as well as surgical devices and a variety of devices in reproductive health, including vaginal rings, diaphragms and male and female condoms. Experience with combination drug/devices includes injection systems for pain management. View additional information on Health Decisions experience with medical devices.
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 provides sponsors with data-capture solutions that allow real-time access to reactogenicity data, as well as the opportunity to use electronic source documents for reduced monitoring. The result is lower SDV costs and faster site closeout and database lock. View additional information on Health Decisions’ vaccine expertise.
Download a fact sheet summarizing Health Decisions’ therapeutic expertise. Download Fact Sheet