Late Stage Research

Late stage experts work closely with you to develop creative, flexible solutions to help you realise your product’s greatest value.

  • Overcome challenges and maintain control in the complex post-approval environment with study designs tailored to your unique needs and budget
  • Rely on our full range of late stage services, deep expertise and access to worldwide patient populations to meet your late stage research requirements

At GCR, our understanding of the complex post-approval environment combined with decades of experience in product development—spanning early stage, product launch and post-approval support—translate into a proven ability to deliver effective study designs that are tailored to meet clients’ specific objectives, marketplace needs and regulatory requirements.

late stage research

Collaborative, Flexible Approach

GCR’s late stage experts focus on our clients’ unique challenges. We take a collaborative approach to customising study designs that meet each client’s needs and budget. Our operational model is tailored to meet project-specific goals and client expectations with expert input from medical, clinical, project management, regulatory and epidemiological functions.

Our late stage research services include:

  • Investigator-initiated research
  • Risk mitigation
    • Risk management plan
    • REMS
    • PAES/PASS
    • Regulatory post-marketing surveillance
  • Real-world outcomes
    • Health economics and outcomes research (HEOR)
    • Pragmatic trials
    • Patient-reported outcomes
    • Epidemiology
  • Observational research
    • Cohort studies
      • Prospective
      • Retrospective
  • Infant follow-up studies
  • Registries
    • Disease
    • Pregnancy exposure
    • Product exposure
  • Expanded access and compassionate use programs
    • Named patient
    • Treatment use
  • Extended access programs
  • Interventional
    • Phase II-IV
      • Practice informing
      • Publication
    • Lactation/placental transfer studies
    • Consumer health