Post-Market Evidence
Study Close-Out & Archiving
Close studies with controlled reconciliation, documentation, database and archive readiness.
When This Service Is Needed
Needed at the end of a clinical study, once the last participant has completed follow-up and all outstanding actions need to be resolved before database lock.
How Bioexcel Approaches the Requirement
Bioexcel runs site close-out visits, reconciles outstanding actions and confirms TMF completeness before supporting database lock and preparing the archive index.
Scope of Support
What Bioexcel Provides
Site close-outOutstanding action reconciliationTMF completenessDatabase lock supportFinal reportsArchive indexHandover
Key Deliverables
- Close-out visit reports
- TMF completeness confirmation
- Archive index
- Final study report
Data / Regulatory Interfaces
Coordinates with clinical monitoring, data management and biostatistics for final database lock.
Typical Engagement Model
Full-Service PartnershipFunctional Service ProviderProject-Based SupportConsulting & Advisory
Discuss Your Study Close-Out & Archiving Requirement
Share your program details and Bioexcel can help scope the right level of support.