The CRO Vendor Qualification Audit Checklist

Exams that determine vendor suitability are vital. A careful assessment of potential clinical development vendors can avoid risks and facilitate successful clinical studies.

But without specific regulatory guidance, VQ processes are highly variable and cost sponsors/CROs a significant amount of time, resources, and budget. Assessing VQ could reduce costs while simultaneously improving quality.

1. Vendor Statement of Work (SOW)

Statement of Work documents detail a project’s goals and objectives, how the work will be accomplished, expected deliverables from vendors and payment terms and milestones for completion. Additionally, timelines should also be included in such statements of work.

An SOW can serve as the basis of an RFP or Master Services Agreement later, by clearly communicating an organization’s terms and responsibilities to prospective contractors. A detailed SOW may reduce disputes while improving budgeting and cost control – while potentially helping prevent delays or unexpected costs from cropping up during its lifecycle.

2. Vendor Quality Agreement (VQA)

When using multiple contract service providers for one project, it is strongly advised that they enter into a quality agreement (QA). The QA agreement should encompass the scope of work for each contracted service, assign product release responsibilities to specific individuals or departments and create processes for overseeing component suppliers and conducting sample analysis.

Quality agreements must include provisions that permit owners to inspect and audit contract facilities to ensure CGMP compliance for specific operations, as well as address communication of inspection observations and for-cause audits between the parties involved.

Many sponsors and CROs follow a routine process for assessing vendor qualifications that begins with Request For Information (RFI) and concludes with Vendor Quality Assessments (VQA), often conducted onsite. Such evaluations place unnecessary burdens on vendors as they require multiple redundant assessments per clinical trial to be repeated for proper assessment.

3. Vendor Statement of Compliance (SOC)

Setting out vendor security expectations through formal rules and policies is one of the best ways to avoid data breaches. This should be especially important at the outset of relationships and can be documented either through a contract of agreement or organizational SOPs. In addition, regular requalification audits should take place to make sure your vendor is not at risk and following regulations, protocol requirements, as well as that any previous findings have been addressed appropriately.

Industry lacks high-level standards for vendor qualification (VQ), placing significant burdens on sponsors due to time, cost and resource requirements of conducting these reviews. Avoca’s Diligent Qualification Platform helps alleviate such burdens through efficient, repeatable processes which reduce variance costs cycle times for sponsors and CROs alike.

4. Vendor Documentation

Vendor requalification audits are investigations of results related to contracted services provided by vendors and may include reviewing any sponsor data that the vendor processes or manages for them. They typically occur periodically throughout an investigation, guided by its quality assurance procedures, standard operating procedures (SOPs), or quality management system (QMS).

Requalification involves an evaluation of a vendor’s organizational structure, work allocation processes, project milestone management techniques and cost estimation and resourcing capabilities as well as any previous regulatory observations or regulatory observations made against the vendor. Documentary evidence of their gap assessment CAPA plan implementation must also be submitted. EGLS helps sponsors cut time, resources and costs associated with clinical trial vendor qualification through innovative risk evaluation methodologies.

5. Vendor Training

This virtual course will assist in creating a comprehensive vendor oversight process for R&D projects that you need to outsource, as well as ways of effectively working with CROs and vendors to avoid missteps.

Vendor Qualification Assessment (VQA) is an integral step in clinical trial processes that ensures potential vendors meet your specific needs in terms of personnel and infrastructure. VQA assessments can either be conducted remotely or as part of an official VQA audit process.

Requalification or in-process audits should also be performed based on your organizational SOPs and at key points throughout a study to ensure your program does not come at risk, that vendors comply with regulations, protocol requirements, and are responding appropriately to previous observations. SimplerQMS provides secure storage for all your clinical research vendor documents and records so you can easily access them at any time.