Vendor & Supplier Management

Proper oversight of vendors and suppliers is crucial for the success of every clinical trial. Versiti Clinical Trial Services provides vendor and supplier management services to ensure patient safety throughout the duration of each study and mitigate the risks and financial implications of costly change orders, rework, non-productive clinical sites, trial delays and data quality issues.  

We leverage our expertise to monitor supply issues and identify risky vendor situations through a variety of supplier management solutions, including:

GCP Audits

• Conduct GCP audits for Phase I facilities, CROs and trial sites.
• Provide SOP development and training and assess compliance to FDA/EU regulations, and current ICH E6 guidelines
• Review CRO procedures and compliance with the monitoring plan
• Review site compliance with the clinical protocol
• Review qualifications of the clinical trial sites and investigator(s)
• Review the content of SOPs to ensure procedures and systems used are compliant with applicable guidelines and regulations
• Evaluate medical laboratories used to support clinical trials

Good Manufacturing Practice (GMP) Audits:

• Site/supplier audits, mock FDA inspections, PAI readiness assessments
• Validation, complaint handling, CAPA, and manufacturing process reviews

Good Laboratory Practice (GLP) Audits:

• Facility and data integrity checks, SOP compliance, sample handling assessments

Areas of expertise across drugs, biologics, devices, diagnostics, nutraceuticals, dietary supplements, combo products, compounding pharmacies and radiopharma include:

• Clinical—21 CFR Parts 50, 54, 56, 312, 314, 361, 812
• Manufacturing—21 CFR Parts 210, 211, 111, 820, 600, 601, 610
• Non-Clinical—21 CFR Part 58
• Electronic Records/Signatures—21 CFR Part 11
• ISO—13485:2016, 14155:2020, 14971:2019, 9000s, 62304:2006, 15189:2012, 17025:2017
• ICH—Q7, E6, E2A
• Compounding Pharmacy—USP 797
• Canadian Medical Device Regulations—SOR-98-282
• European Directives—2001/20/EC, 2005/28/EC, EU GMP Annex 1
• European Regulations—IVDR (2017/746), MDR (2017/745)