RPS Services

First-In-Human Studies through Approval and Ongoing Safety Monitoring & Post-Marketing Studies

Analytical & Product Development

  • Analytical Method Development and Validation
  • Drug Substance and Product Characterization
  • In-Process, Stability, Microbiological, and Release Testing
  • Quality Assurance & Control
  • Formulations

Clinical Operations

  • Protocol/Country Feasibility
  • Investigator Recruitment
  • Study Start-Up Services
  • Project Management
  • Site Monitoring and Management

Data Services

  • Clinical Data Management
      • - EDC and Paper-Based Solutions
  • Biostatistics
  • Biostatistical Programming

Medical & Regulatory Affairs

  • Medical Monitoring
  • Drug Safety & Phamacovigilance
  • Medical Writing
      • - Regulatory Documents and Publications
  • Regulatory Affairs Services and Consultation
  • Medical & Scientific Liaisons

Quality & Training Services

  • Quality Management
      • - Audits & Inspections
      - Controlled Document Management
      - CAPA
      - Consulting & Risk Management
  • Training
      • - Employee
      - Investigator
      - Protocol