Vendor Risk Management in Clinical Trials

The clinical research industry relies heavily on third-party vendors or Contract Research Organizations (CROS) for a variety of services, such as protocol development, regulatory submission assistance, and everything in between, but, even as sponsoring organizations continue to outsource clinical trial activities, they can’t outsource clinical trial oversight, including vendor management. Sponsors who rely on CROs must manage vendors effectively, both as a legal requirement and a business necessity.

From a regulatory perspective, the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice E6 (R2) requires that sponsors have a system in place to manage vendor performance and quality. Establishing the right vendor risk management program requires a strategic combination of rules, tools, processes, and people.

10 Vendor Risk Management Program Requirements

For the best results, ensure your organization's vendor risk management includes the following:

• Program Governance: A vendor oversight program should be tailored to your organization's size and complexity. You should establish a risk-based approach to vendor vetting and management.
• Governance Documents: You must define and document your rules and requirements for your vendors and formalize them with official policies, processes, and procedures.
• Clear Roles and Responsibilities: Create clearly defined roles and responsibilities for all stakeholders, internal and external.
• Vendor Vetting: Establish a standardized vendor vetting and selection process. You should define your steps for requesting proposals, performing rigorous competitive analysis, verifying references, or other steps that may be required during the process.
• Risk Assessments: Identify and assess risks associated with the vendor as well as their product or service. Then, establish a risk rating for each prospective vendor using a standardized inherent risk assessment. The extent of oversight and management should be based on the inherent risk ratings of vendors.
• Due Diligence and Document Review: Carefully review all documentation evidencing the vendor's controls including training, issue management, corrective and preventive action (CAPA), knowledge management, clinical risk management, inspections, and audits. You should also include regulatory information security practices, compliance status, litigation history, and reputation in your standard due diligence. The trial master file (TMF) must also be reviewed. A TMF is your compilation of documents that shows the clinical trial has been performed in compliance with regulatory requirements.
  
• Comprehensive Contracts and Agreements: Clinical quality agreements are essential. Your legal agreements should also cover performance, quality, risk management, documented service level agreements, indemnification, insurance requirements, and a right to audit.
• Monitoring and Oversight: Establish an oversight plan specifying how you will monitor and manage each vendor. Risk reassessments should be conducted regularly, and vendor controls should be reassessed. Make sure your TMF is up-to-date and ready for regular inspections.
• Performance Management and Corrective Action: Long-term success depends on regular performance evaluations and reviews. Track your vendors' performance and provide feedback. If there are policy or performance issues, let them know immediately and develop a plan to resolve them within a reasonable timeframe.
• Vendor Risk Management Tools and Technology: Vendor risk management tools can help you track and manage your vendors, automate your workflow, simplify administrative processes, and generate reporting. These tools can also standardize important processes such as risk assessment, due diligence document collection, contract management, performance tracking, and reporting, allowing your organization to focus on vendor oversight and management.

When it comes to vendor risk management, a sponsoring organization needs to understand the risks present in the relationship as well as how to identify and mitigate these risks. Management and oversight of is the sponsor's ethical and regulatory responsibility, but there are also many benefits beyond compliance. An effective vendor risk management program can help prevent costly delays and rework while enabling quality clinical trials.