Biopharma Trials

Over 25 years, Health Decisions has achieved stunning successes in a variety of studies of small-molecule drugs and biologics.

Health Decisions provides a full range of high-quality clinical development services for both small-molecule drugs and biologics across all phases. While conducting hundreds of biopharma trials over the past 25 years, Health Decisions has achieved stunning successes and developed both broad therapeutic expertise and exceptional strength in core areas. Our experience and expertise include proof-of-concept, dose-finding, dose-selection and pivotal trials for small-molecule drugs and studies of a variety of biologics, including monoclonal antibodies, therapeutic and prophylactic vaccines and hormones. Core strengths include studies in women’s and reproductive health, endocrine and metabolism, neurosciences and infectious disease.

Biopharma Clinical Development Services

  • Protocol Development
  • Project Management
  • Site Feasibility and Selection
  • Site Management
  • Site Monitoring, including Risk-Based Monitoring
  • Patient Recruitment and Retention
  • Data Management
  • Statistical Programming, Analysis and Reporting
  • Interim Analyses
  • DSMB Oversight and Coordination
  • Regulatory Oversight and Compliance
  • Supply Management
  • Randomization
  • Medical Writing
  • Quality Assurance
  • Safety Management
  • Medical Monitoring
  • Training

Biopharma Clinical Trials: Drugs

Health Decisions’ experience and expertise include Phase I-IV trials in Women’s Health and Reproductive Health, Oncology, Neurosciences, Nephrology, Infectious Disease, Vaccines, Endocrinology and Metabolism, Gastroenterology, Pediatrics, Hematology, Dermatology, Rheumatology and Orthopedics. We have reduced timelines and risk and increased success rates and NPV for sponsors of drug trials for 25 years. Despite the growing importance of biologics, we expect small-molecule drugs to maintain a substantial presence in development portfolios for the foreseeable future. Our case studies and brief success stories include many examples of studies of small-molecule drugs. View the case study of a metastatic breast cancer study.

Biopharma Clinical Trials: Biologics

Clinical development of biologics presents distinct challenges. Because therapeutic proteins typically target patients with specific mutations, efficient recruitment of specialized populations is essential. Biologics trials also demand constant vigilance for safety issues because of potential immune reactions and infusion reactions. Dosing often does not involve the type of dose-response curve characteristic of small molecules. Health Decisions experience includes trials of monoclonal antibodies, therapeutic and prophylactic vaccines and hormones. We understand the clinical and operational issues involved and have developed specialized capabilities. View the Health Decisions White Paper, Reducing Risk in Biologics Trials: Targeted Trials for Targeted Therapeutics.