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:

Vendor audits are essential for maintaining compliance throughout the supply chain. Versiti Clinical Trials has deep expertise in developing efficient and compliant GxP quality systems, third-party vendor management plans, and risk management programs in compliance with FDA, European and other global device, biopharma and diagnostic regulations. 

Through our audit process, our team works to identify gaps in suppliers’ quality management practices, delivering actionable insights for improvement. Our team possesses extensive domestic (U.S.) and international experience and can advise the entirety of the supply chain, from raw materials to finished products. 

With Versiti Clinical Trials’ comprehensive expertise, organizations can navigate vendor management challenges with confidence, ensuring compliance and upholding the highest quality standards.

GCP Audits

• Conduct specialized GCP auditing focusing on the issues associated with Phase I facilities
• Provide training and support SOP development associated with the current phase of development
• Assess compliance with FDA/EU regulations and ICH guidelines
• Evaluate the EDC and databases used to track SAEs and IND Safety Reports
• 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

GMP Audits

• Audits of sites, suppliers and supporting laboratories
• Audits appropriate for clinical trial and marketed products
• Quality systems
• Validation
• Remediation
• Inspection readiness mock audits that mimic the FDA GMP inspection process and provide an assessment of readiness for all types of FDA inspections
• Gap analyses to determine current compliance with FDA regulations

GLP Audits

• Assessment of laboratories, records, facilities, test articles, test systems, facilities and chain of custody for compliance with GLP regulations
• Laboratory evaluation (personnel training and records, materials, experimental or analytical documentation, etc.)
• Laboratory facilities (inspection of sample collection, preparation and storage procedures, analytical procedures and raw data audit, QA documentation audit, etc.)
• Review SOPs for compliance with international standards
• Records, reports and record/sample retention

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)