The vendor oversight and management in clinical studies and investigations

Di Daniela Salvati - Clinical Project Manager

Involvement of external vendors and providers is common during execution of clinical trials and investigations. Activities to be managed, requirements to be met and procedures to be followed are more and more complex, requiring competent personnel with a specific and solid knowledge and preparation on different topics and aspects relating to the rules that regulate their implementation.

One of the most critical aspects in the vendor management process is the oversight of provision of services requested, to be accurately planned and conducted during their execution.

Even if a vendor has been appropriately selected and qualified, each delegated project should be monitored and specific processes, requirements and characteristics to be kept under control should be identified, especially if their impact on the outcome of the project is considered to be critical. 

Implementing an oversight plan is the best approach to ensure vendor supervision and establishing the oversight team guarantees the effective oversight plan management.

The first step in the vendor oversight is the definition of roles and responsibilities; Clinical Operations and Quality should collaborate to perform the risk assessment related to each activity delegated to the vendor involved. Starting from the risk assessment, specific mitigating actions should be identified in the oversight plan. Examples of such actions are analysing and monitoring of key performance indicators, Quality Control activities, holding regular alignment meetings, creating ad hoc documents and procedures, detailed tracking of activities aimed to mitigate potential risks. In this way, the ongoing oversight of critical processes guarantees the successful execution of delegated activities. 

To ensure a positive and collaborative relationship with vendors, it is important to share from the beginning the objectives, the expectations and the mitigation actions previously identified. This allows all parties to be focused on common goals, with a positive and proactive approach, thereby reducing mistakes, misunderstandings, and delays in timelines.

In summary, setting up an oversight team and plan, conducting risk assessment and identifying mitigation actions, closely cooperating with vendors and regularly evaluating their effectiveness in executing delegated activities are key aspects of a vendor oversight process. 

Contact us to be sure to properly manage your vendor: we can support you in the initial selection and qualification and in the oversight process.