Major Therapeutic Areas

  • Allergy
  • Anti-infective
  • Cardiology
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Metabolic Disorders
  • Neurology
  • Oncology 
  • Ophthalmology
  • Orthopedic
  • Pulmonology
  • Rheumatology
  • Urology

Experience Overview

Hundreds of Phase 1 through 4 Clinical Studies of drugs, medical devices, biologics, and diagnostics

  • Oncology, Neurology, & Pulmonology comprise the largest portion of our work, including late-phase trials
  • Rare Disease portfolio with broad experience across multiple therapeutic areas

NDAs and MAAs (EU) with submissions in neurology, oncology, pain management, respiratory, allergy, and metabolic disorders

Clinical Development Strategy and Protocol Design Consultation across a variety of therapeutic areas

FDA Interactions by PROMETRIKA PhD biostatisticians providing pre-meeting consultation/preparation and meeting participation/presentation for pre-IND, SPA, End-of-Phase 2, pre-NDA, and Advisory Committee meetings

More than 175 Sponsors, ranging from startup to top biopharmaceutical companies, with a high percentage of repeat business through these established relationships

Independent Data Monitoring Committee (IDMC) services, including charter development, safety and interim efficacy analyses, committee participation, and meeting coordination

Rescue Projects, including mid-stream rescue of full-service studies and remediation of a number of completed studies and NDA documents, meeting sponsors’ expectations of quality within the required timelines