Quality
The Venn Life Sciences quality department is an independent group which is responsible for ensuring the quality of work provided by Venn and that our work is conducted in compliance with the relevant GCP guidelines, relevant international regulatory requirements and applicable Standard Operating Procedures (SOPs).
Our quality team is also responsible for the Venn quality management system and conducts internal company systems and project audits as well as vendor audits to ensure that vendors work to the same quality standards.
The team have extensive clinical experience and routinely conduct GCP, Vendor, Study Specific, Site, TMF, Database & Data Management & Clinical Study Report Audits.
Our Audit Services Include:
Study Specific Audits
- Clinical Study Protocol Audit
- PIS/ICF Audit
- e(CRF) Design Audit
- Investigator Site Audit
- Trial Master File Audit
- Database/ Data Management Audit
- Statistics/TFLs Audit
- Clinical Study Report Audit
Vendor Audits
- Full Service CRO Audit
- Phase 1 Unit Audit
- Data Management & Statistics
- Archives
- IT/CSV
- Clinical Laboratories
- IMP Manufacturers
- Wholesale Distributors
- Translation Agencies
Other Services
- Mock GCP inspection
- System/process audits
- GCP training
- QMS support/ review/ admin
- Study documents QC/ review
- CSV documents – QA review
- Auditor training