Services

Clinical Trial Services

Project-level services:

Site-level services, including:

  1. Pre-study:
    • Investigational site identification
    • Feasibility questionnaire management
    • Investigational site qualification visits
  2. Study Initiation
  3. Clinical trial site management and monitoring:
    • Traditional or risk-based investigational site monitoring
    • On-site or remote site monitoring visits in accordance with the source document verification plan
    • Investigational product accountability
    • Regulatory document tracking and maintenance
  4. Study closeout
  5. Lead CRA activities including site visit tracking, review of visit reports and CRA management.

We also provide non-project specific services, including development of clinical monitoring SOPs and associated forms, central IRB interactions, and vendor interactions.

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