In addition to strength in core therapeutic areas, Health Decisions has expertise and has performed successful trials in a variety of additional therapeutic areas. Among these are gastroenterology and nephrology.
Expertise in Gastroenterology
Health Decisions has extensive experience in GI clinical trials. We understand the needs and concerns of the patient populations, the competitive landscape and the operational challenges of GI studies, including limiting interrater variability in assessment of endoscopy recordings, enrolling placebo-controlled studies and enrolling studies that involve repeated intrusive procedures such as endoscopy. In addition, Health Decisions appreciates the importance of emerging outcome measures such as mucosal healing in addition to traditional measures of clinical remission in Inflammatory Bowel Disease (Crohn’s disease and ulcerative colitis).
Experience in Gastroenterology Clinical Trials
Health Decisions has conducted clinical trials of therapeutic agents for a variety of gastroenterology indications, including:
- Ulcerative colitis
- Crohn’s disease
- Gastro-Esophageal Reflux Disease (GERD)
- Irritable Bowel Syndrome
- Stomach and duodenal ulcer
- Chronic idiopathic constipation
Gastroenterology Site, Investigator and KOL Relationships
The Health Decisions GI team has strong relationships with sites and investigators, including KOLs, and is proficient in the use of Health Decisions’ advanced systems and processes to keep sponsors in control and ensure that studies meet their goals. Health Decisions’ study management tools enable our proactive study teams to manage sites effectively, keep enrollment on track and work closely with sites to maximize subject retention. Health Decisions’ database of GI sites includes 570 sites in the US, Europe, South America, Australia and New Zealand and we have experience working with 361 GI sites, thousands of GI patients and numerous GI studies. The database includes 320 US and Canadian sites with GI research experience. Sites include a mix of large GI private practices, university/research hospitals, independent clinical research centers and VA hospitals.
Health Decisions has conducted Phase I-IV nephrology clinical trials involving traditional drugs, biotherapeutics and medical devices and has served as a strategic clinical development partner for pharma giants as well as young companies with a single product. Health Decisions provides strong design expertise and operational excellence, identifying the optimal path to approval and efficiently executing every step from initial planning to regulatory submission. Our nephrology team understands the challenges of conducting successful studies, including working with dialysis subjects and in the dialysis setting.
Experience in Nephrology Clinical Trials
Health Decisions’ experience in nephrology clinical trials includes the following indications, therapeutic agents and devices:
- CKD studies including stage 5
- Pharmacokinetic and pharmacovigilance monitoring
- Biotherapeutics, e.g. renal cell carcinoma vaccines
- Hemodialysis stent
Health Decisions’ oncology experience includes Phase I-IV studies of small-molecule drugs and biologics in a variety of indications. Health Decisions provides strong design expertise and operational excellence, identifying the optimal path to approval and efficiently executing every step from initial planning to regulatory submission. Despite the challenges often involved in enrolling oncology studies, Health Decisions has developed and executed successful strategies for meeting sponsors’ goals. Among other notable achievements in oncology, Health Decisions created the first adaptive design approved by FDA’s Office of Hematology Oncology Products (then the Office of Oncology Drug Products) and brought a breast cancer product to market a year ahead of schedule.
Health Decisions’ oncology expertise and experience includes studies in the following broad categories:
- Traditional chemotherapeutics
- Biologics such as immunotherapeutics; targeted therapy including monoclonal antibodies; and complex autologous products
- Preventative research and diagnostic cancer screening
- Brain cancer
- Cachexia in oncology subjects
- Cervical cancer
- Colorectal cancer
- Gastrointestinal cancer
- Malignant melanoma
- Metastatic breast cancer
- Multiforme glioblastoma
- Prostate cancer
- Prostatic intraepithelial neoplasia
- Renal cell carcinoma
- Solid tumors
- Squamous cell carcinoma of the head and neck
Additional Experience and Expertise
In addition to experience in core therapeutic areas and areas listed above, Health Decisions has expertise in a variety of other areas, including: