Trial Preparation

Get Your Study Ready with the Best Chance for Success

GBC supports clients with the identification, qualification, and approval of suitable partners including clinical sites and labs.

Pre-Trial Site Qualification and Site Qualification Visits (SQVs)

GBC utilizes study-specific qualification questionnaires to assess site strengths and weaknesses, gathering information on the local investigator, research staff, infrastructure, patient population, and IRB requirements.  GBC site qualification services include:

  • Development of Site Recruitment Questionnaires (SRQs)
  • Conducting Telephonic Site Screening Interviews
  • Reviewing Protocols with Potential Investigators and Obtaining Feedback
  • Coordination of Qualification Visit Travel
  • On-Site Qualification Visits (SQVs), Interviews, Inspections, and Audits
  • Documenting Findings in a Site Qualification Report (SQR)

Clinical Trial Agreement (CTA) Negotiation

GBC negotiates win-win contractual arrangements with study sites. Services include:

  • Development of Study Site Budgets
  • Contract Key Terms and Performance Milestones
  • Risk Sharing Models
  • Financial Negotiation
  • Final Contract Execution

IRB / EC Submissions and Approvals

GBC manages preliminary submissions, approvals, re-approvals, and tracking for local and central institutional review boards (IRBs) and ethics committee (ECs). Services include:

  • Manage Protocol Submissions, Reviews and Approvals
  • Coordinate Investigator Approvals
  • Re-Submissions and Re-Approvals
  • Manage Protocol Revisions and Amendments

Trial Master File (TMF) Management

GBC supports the management of trial documentation. Services include:

  • Preparation of Site Regulatory Binders (Standardized Formats)
  • Central Maintenance of Essential Study Documentation
  • Regular Completeness Review and Audits
  • Support for Electronic Trial Master File (eTMF) Solutions

For additional information on GBC's clinical trial services please contact or register and send us your inquiry here.