Late Stage Observational Research And Patient Registries

Increasingly, health authorities, insurers, regulators, policymakers, physicians and patients are all seeking information to better understand “what works” in the real world; that is, in settings that reflect how diseases are treated and how clinical products are actually utilized without the controls and constraints of traditional clinical trials. Thus, studies must be designed to observe processes and outcomes in actual medical practice settings – without disrupting the very practices being observed! This requires truly unique experience.

Our Late Stage team’s approach to Observational Research begins by affirming the strategic foundation for a study - “why” a non-interventional project is being undertaken is the basis for “how” its operational components should be structured. An understanding of both the opportunities and the limitations of observational research is crucial to the organizational alignment necessary for success.

Our experts provide our clients with valuable insight throughout the study, ensuring expectations are appropriately set and met, through pragmatic (yet scientifically sound) design and operational cost-efficiency. By applying design and operational approaches specifically focused on Observational Research, we can ensure outstanding results in the management of participating sites, of all data management and analytical processes, and of the overall project.

  • Study design
    • Statistical analysis planning
    • Communications planning
  • Overall project management
    • Notifications
    • Management of Scientific Advisory Panel
  • Protocol / guidelines development
    • Informed consent
    • Case report forms
  • Site recruitment and management 
    • Site agreements
    • EC/IRB approvals
  • Data management
    • EDC, EMR
    • Paper, hybrid
  • Quality management
    • Site interaction
    • Data quality monitoring and SDV
    • Safety reporting
  • Analysis and reporting
    • Presentations
    • Abstracts
    • Manuscripts

Late Stage Brochure