Clinical Research

Therapeutic Area Experience
Focus on NIS
Regulatory Trials
e-CRF
QA Activities
Medical Writing
Phv in Clinical Trials

GB Pharma is a full service partner that can provide support at all stages of clinical development:

  • Interventional studies Phase I and Phase II-IV
  • Non Interventional Studies (NIS): Observational Registry (OBS), Epidemiological (EPI), Outcome Research (OR) also for Market Access
  • Regulatory Studies (PASS, PAES)
  • Medical Device Studies
  • Food Supplement
  • Ideal partner for No-Profit Studies

Services

  • Study Feasibility and Centres Selection
  • Study planning and documents preparation
  • Regulatory and Ethic Submissions
  • Project Management
  • Clinical Monitoring
  • Safety Management
  • Data Management, eCRF development, validation and management
  • Statistical Analysis
  • Medical Writing
  • QA (including Audit) and Trainings on clinical research activities
  • Vendor selection, certification and management
We also provide insourcing services,concerning the following positions:
  • Project Manager
  • Clinical Trial Coordinator; Clinical Monitor
  • Study Manager