You've Chosen Your Vendor(s), But Have You Thought About Their Oversight?
By Megan Liles, principal, Liles Clinical Trials Consulting
It was only a few years ago that in early phase clinical trials, particularly in oncology, vendor management consisted of…. well, an EDC system, maybe a central IRB, central imaging (for collecting and holding scans), and then some pharmacokinetic or biomarker analyses done at bioanalytical labs. But really, everything else was done at the sites. And yes, multiple vendors were the norm for later-phase trials — but even that was primarily limited to central labs, IRB, IRT, imaging, and translations.
Over the last few years, however, the number of clinical trial vendors has exploded. A dizzying array of vendors are ready to support clinical trials and, in many cases, offer niche services, such as technology-based platforms or software, participant recruitment and/or navigation services, mobile health, clinical trial agreement negotiation, and vendor, site, and participant payments, just to name a few. The team at Florence recently assessed the eClinical vendor landscape and identified over 800 vendors — and that was just technology-focused vendors! Understandably, there is a keen interest in exploring these services. In many cases, these service providers are helmed by teams with a wealth of experience who readily share best practices and have developed systems and processes that are highly adaptable and flexible.
Thinking back to some of the clinical trials I have been recently involved with, a global Phase 3 trial had about 20 vendors involved, and I have just recently learned of another that had over 50 vendors. Whew! That's a lot to keep track of, especially when GCP guidelines rest the responsibility of vendor (and subcontracted vendors) oversight firmly on the sponsor’s shoulders, according to ICH GCP E6 (R2) 5.2.2 Addendum. Vendor management has now become an even more complex task involving multiple stakeholders, and it may often be overlooked, especially in the oversight of subcontracted vendors. Thus, it is extremely important to have an approach to track vendors engaged in clinical trials and ensure there is proper oversight.
Developing Your Vendor Strategy
As a first step, consider what vendors will be needed for the study based on the trial design and where there is value in combining certain services within one organization, such as a CRO, or if certain activities should be outsourced to specialty vendors. For example, will there be a need for mobile health, PROs, or participant recruitment vendors? Are central readers needed for imaging and/or electrocardiograms? Are there multiple bioanalytical labs involved that would necessitate a specimen management system? Then, depending on the number of planned clinical trials in the pipeline, a functional service provider (FSP) approach may be beneficial across the program as several efficiencies can be realized, especially in areas like data management, investigator contract/budget negotiations, and pharmacovigilance. Determining the vendor strategy for a clinical trial and getting the necessary contracts (and approvals) takes time, so this should be factored into your overall study timeline.
Establishing Your Vendor Oversight Plan
With vendors now in place, developing a vendor oversight plan is essential for determining how to provide oversight of all trial-related vendors. Ideally, it should list all CRO- and sponsor-contracted vendors, detailing who’s responsible for selecting and qualifying vendors, what services the vendor is providing, who’s responsible for managing the vendor, and who holds the contract and pays the vendor. The vendor oversight plan should also detail key activities that will be performed for each vendor category or service to ensure proper oversight. This should include items such as how clinical monitoring, risk management, protocol deviations, quality issues, team training, site selection, data quality, or TMF reviews will be monitored throughout the study. The responsibility for reviewing vendor-developed materials, status reports, and metrics and how this information is disseminated internally at the sponsor and who is responsible for filing sponsor-managed vendor documents in the TMF should also be noted. The vendor oversight plan should be updated regularly (i.e., at least annually) or as new vendors are brought onboard and there should be an established plan on how compliance with this plan will be monitored (e.g., internal project reviews, one-to-one meetings with the project manager, etc.)
Determining Vendor Monitoring And Communication
Achieving a successful collaboration between sponsors, CROs, and third-party vendors is critical to the effective management of a clinical trial. Central to this is the efficient monitoring and oversight of vendor performance and the development of seamless communication channels.
Understanding How A CRO Monitors Performance
For CRO-managed vendor contracts, it is important to understand whether the CRO has an internal governance structure to monitor third party vendor performance, who is responsible for monitoring performance, and what metrics are maintained. Another consideration for subcontracted vendors is how contract amendments are handled by the CRO team, the potential budgetary impact of both the vendor costs and the CRO team cost for handling the contract amendment, and how the sponsor team is kept informed of the status. Often, sponsors feel they do not have the clearest line of sight with subcontracted vendors and so the study communication plan should detail how quality issues are escalated to the sponsor and delineate the points of escalation both within the CRO and the sponsor.
Keeping Everyone In The Loop
With communication being a two-way street, if the sponsor is holding the contract and managing vendors, there should be a process in place for how the CRO team and other vendors are kept apprised of any relevant information that may affect their services. As an example, if new vendors are implemented during the trial or if a protocol amendment is issued, the sponsor should consider how this may impact each vendor. This, again, is where having a robust communication plan in place is beneficial, so these communication pathways are clearly defined.
Mixed Meetings Get Mixed Reviews
While on the topic of communication, meetings that bring together multiple vendors may seem like a good idea to ease meeting fatigue. However, feedback that I have had recently from some vendors is that these meetings can complicate relationships. Inevitably, questions came up where vendors felt, in answering sponsor inquiries, they were speaking poorly about another vendor in attendance (with whom they may be working across multiple projects). So, while I’m not opposed to this type of strategy, it is important to create a space for vendors to provide constructive feedback in a less public forum.
Governance Structures Keep People Accountable
Lastly, for sponsor-managed vendors, an established governance structure should be implemented, especially when the vendor is working across a portfolio of studies. Most CROs will readily implement operational and executive governance meetings that include the monitoring of sponsor- and CRO-agreed KPIs. Increasingly, I have found other service providers (recruitment, engagement, and recruitment management platforms) include some type of governance, whether it is regularly scheduled oversight calls or a formal meeting, as part of their processes. However, for those who did not, by simply asking, most were amenable to at least a regular executive oversight call as an opportunity for both sides to provide feedback.
Proper Vendor Oversight Is Achievable
How we manage clinical trials has certainly evolved over the last several years and there is a need for bringing more trial-related vendors into the fold. With a clear vendor strategy, including how to onboard additional vendors throughout the study, and an effective vendor oversight plan, the art of vendor management is something readily attained for even the most complex of clinical trials.
About The Author:
Megan Liles is the founder of Liles Clinical Trials Consulting and has over two decades of clinical research experience. Specializing in the management and execution of global clinical trials across diverse therapeutic areas, Megan optimizes trial participant recruitment through innovative strategies and technology integration. Through her consultant work, she delivers tailored solutions that maximize trial outcomes and ultimately contribute to improving patient care and treatment options.