Endocrine and Metabolism

We understand the challenges of trials in diabetes mellitus and other endocrine and metabolism indications.

Health Decisions’ clinical development staff has extensive experience and expertise in studies in endocrine and metabolic disorders. 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 indications with many active clinical trials and thus a wide range of choices for patients.

Experience in Endocrinology and Metabolism Clinical Trials

Health Decisions’ experience in endocrinology and metabolism clinical trials includes the following indications:

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus
  • Hypothyroidism
  • Hyperthyroidism
  • Adrenal disorders
  • Pancreatitis
  • Gallstones
  • Goiter
  • Grave’s disease
  • Osteoporosis
  • Hypocortisolism
  • Hypercholesterolemia
  • Hyperlipidemia
  • Metabolic syndrome
  • Obesity
  • Polycystic ovary syndrome
  • Hereditary endocrine disorders

Key Strengths in Endocrine & Metabolism Studies

  • Investigator and KOL relationships
  • Site selection
  • Subject recruitment given existing treatments, competing trials, placebo controls
  • Evolving standard of care
  • Understanding of competitive landscape
    • Cardiac safety
    • Effects of inclusion/exclusion criteria
    • Sample-size re-estimation for treatment effect, variability
    • Superiority vs. non-inferiority designs
    • Early stopping for futility or efficacy