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 trials@globalbioclinical.com or register and send us your inquiry here.