Outsourcing Vendors for Clinical Trials

Services are often outsourced to third party vendors for certain clinical trial activities, particularly where a clinical trial activity must be standardised. Such vendor services can include a centralised review of imaging data, central pathology or laboratory analysis and Investigational Product logistics. Following the decision to outsource a service to a third-party vendor for a clinical trial, different vendors are identified and assessed by a documented audit. Sometimes, sponsors or CROs may have worked with vendors before and already have relationships in place, or recommendations to offer. Other times, there is a risk in vendor selection, especially if certain services or providers are yet to be established.

Creating a short list of vendors based on specific criteria can help to select the most suitably qualified and capable vendor. To determine the selection criteria, input may be required from different business representatives, which could include Medical, Financial and Legal.

The key considerations in assessing suitability, is to assess the vendor’s capability in terms of their past experience and performance as well as their infrastructure and resource availability. When assessing past performance, this could be assessed from asking local contacts, viewing testimonials, documented reports gained from working with the vendor, shared knowledge and any outcomes from previous inspections and audits. Depending on the input from different business units, for example, the IT department, assessment and validation of systems, security and SOP compliance would be performed. An inspection of resource availability would take into consideration the available personnel and their training.

One strategy to compare vendors is by providing each vendor with a quality assessment questionnaire, where responses are assessed and compared. Depending on the duration of partnership, specialty of work and whether there has been any change to the vendor since the last interaction, an on-site audit is often the best method for validating the assessment responses.

Even if a vendor is well known, taking the time to construct selection criteria and assess and compare a short list of vendors can result in a successful partnership with the most suitably qualified vendor, which will in turn minimise issues throughout the clinical trial.