Vendor oversight is a trending topic, as both the vendors and the sponsors come to terms to what is expected of each of them and the associated liabilities and responsibilities while partnering together. The sponsor needs to be specific with the choice of the vendor for clinical trials and the selection of vendors that meet the outsourcing requirements.
The selection process of a contract research organization (CRO) involves screening of potential vendors for attributes such as cost estimates, timeline for the project, along with an analysis of the past completed trials and the reputation of the vendor. Cross functional teams on the part of the sponsor including project management teams, Research and Development (R&D) and Quality Control (QC), are involved in the vendor selection process and evaluate the ease of working with a potential vendor while maximizing the services from the same vendor for a specific project.
This is an extract from ‘Clinical Trial Vendor Oversight and Governance’ - download the full whitepaper here.
There are several factors that decide the selection of an appropriate vendor for a clinical trial. These include:
- Vendor experience in the therapeutic area of interest to the sponsor
- Proposed project execution plan
- Approach towards the project and problem-solving plan: definitions for the process of identification issues, drawbacks and the resolution thereof
- Human resources/training
- Organizational chart/Geographic coverage of the vendor
- Compliance, Business ethics
- Data/Computer management systems
- Cost of the trials
1. Vendor screening
This first screening step is achieved by screening the request for proposal (RFP) from the potential vendors once the sponsor provides the objective of the work along with the expected timelines. RFP template can be used to compare vendor bids and should include questionnaire based format for clarifications on the compliance status, corrective and preventive measures (CAPA) and the quality management systems (QMS) and the data management systems used by the vendors. Other certifications as well as terms and conditions for third party outsourcing by the vendor have to be adequately addressed at this stage to ease the screening process and facilitate the shortlisting of potential vendors.
2. Good team chemistry
Team chemistry or the overall positive relationship between the sponsor and vendor project team is one of the key criteria for selection of a specific CRO. Sponsors highlight the importance of a good working relationship between the project teams overlooking from the sponsor side and the project team of the CRO as the teams often work over long periods of time, sometimes lasting years and across geographical locations. It is important that the sponsor and the vendor share same ethical values and problem-solving approach for a successful sponsor-vendor relationship.
3. Conducting a background check
Experience of the vendor, not only for a specific indication, but also the general experience in handling clinical trials is another criterion that weighs high on the scale while selecting a vendor.
4. Reviewing the project execution plan
A sponsor is largely interested in a convincing project execution plan, detailing the resources, countries, and site selection process as well as identification and management of risks associated with the clinical trials. Other criteria for the selection of a vendor include vendor’s geographic location or access to specific markets of interest. Lastly, lowest price may not necessarily be important for the selection of a vendor.
5. Arranging a visit
On-site Audit by the sponsor: before finalizing a vendor, the sponsor generally visits the facility of the vendor to access the capabilities of the vendor and evaluate the compliance status.
6. Formulating a Quality Agreement
Following a satisfactory audit, the sponsor puts a Quality Agreement in place ensuring that the vendor is able to achieve, maintain and demonstrate compliant operations in handling the clinical trials. When a contract with the vendor is finalized, a Statement of Work (SOW) is a legal document that defines the services to be provided, deliverables and timeline for services being performed, the scope with all the study specific details on services performed by the vendor.
As the overall responsibility of the clinical trials lies with the sponsor, vendor management is the key to execute the clinical trials within the assigned timelines. Sponsors should maintain oversight on a regular basis via meetings with vendors and internal team members and check upon the documentation to ensure that project associated problems, if any, are discovered and resolved early. For successful execution of clinical trials, it is important that the sponsor and the vendor remain in tandem when it concerns inputs or guidance as well as in identifying drawbacks and finding optimal solutions to keep the program in the right direction while meeting the timelines. A sponsor oversight plan can include the information on the level of oversight and the documentation required from the vendor for the review.