The world of clinical trials is complex, with many areas of study implementation supported by vendors and third-party providers. This group of Contract Research Organizations (CROs) includes institutes that organize and manage your study fully or just take part in it as Data Management or Clinical Monitoring. There are more and more specialists like Central Laboratories, Imaging Core Labs, IRT (Interactive Response Technology) providers, and others whose services support conducting high-quality, compliant, and timely trial implementations. 

Vendor management comprises the selection of third-party suppliers and their continuous management. Therefore, it is closely related to sponsor oversight activities and will depend on the organization and complexity of your planned clinical trial. In case you are a small sponsor organization, it will be tempting to select a bigger Contract Research Organization, CRO, so that vendor management superficially only relates to one third party. However, also big CROs may subcontract further organizations, e.g., niche providers for specific tasks. It is the responsibility of the sponsor to oversee the qualification and performance of these further providers as well. 

Ineffective vendor management can lead to tremendous risks, such as considerable delays in studies, issues of data integrity, and high costs, among other things. Sponsors must hence have mechanisms in place for effective vendor selection, qualification, and their management to reduce their exposure to risks, ensure that they have oversight, and create good working relationships with these third-party vendors. 

The key objectives of managing clinical trial vendors are to select and qualify the best possible vendors, define clear performance standards, establish vigilant monitoring measures, and foster relationships that encourage ever-better processes by transparent communication and issues-solving mentality.  

Vendor Selection and Qualification  

Identification and selecting a third-party provider is a task orchestrated by the project responsible. Sponsors must, however, ensure that potentially suitable third parties have a Quality Management System (QMS) in place that proves a standardized and guideline respectively regulation-compliant approach to the task that the sponsor plans to outsource. Your organization must therefore have a standardized vendor qualification approach which will be followed for all third parties to be selected. 

 The principle of subcontracting third parties is delegation, whereby it is important that tasks will be delegated, and not the responsibility. The latter will always reside with the sponsor. A risk-based approach takes into consideration the risk that is allocated to the act of outsourcing a specific task to another organization. The more critical the task or process is for your clinical trial, the more thorough the qualification processes should be. Remember, outsourcing as such is already a risk! 

Oversight and Performance Management  

Proactive oversight and continuous monitoring of the performance of vendors against defined metrics are critical during the entire life cycle of a study. A risk-based approach should determine the intensity of oversight activities, such as regular meetings, audit of documentation, key performance indicator (KPI) tracking. Objective quality metrics to measure vendor performance and provide data-driven decision-making include those related to protocol deviations, query rates, issue resolution times, monitoring or audit findings, and overall study delivery timelines.  

The performance of the vendors needs to be overseen continuously, and it is important to appoint experienced individuals for this task. Not only should timelines and budgets be kept, but the quality of the delivered services needs to be verified on an ongoing basis. Maintaining good oversight should always be connected to thorough documentation and pre-defined escalation pathways. If you cooperate with a bigger organization, a governance model might be an option to establish a communication link not only on the project but also at the organizational level. 

Relationship Management and Continuous Improvement  

While formal oversight is definitely crucial, equally significant is having a partnering mentality and developing strategic relationships with key vendors. Open communication, transparency, and a common dedication to the success of a trial set the stage for process improvement and innovation. Put in place mechanisms for ongoing feedback both ways: celebrating excellent performance through recognition/rewards programs further incentivizes your vendors to over-deliver.  

Leverage vendor advisory boards for an outside-in view and development of new solutions to emerging challenges in study conduct. For long-term partnerships, , conduct complete re-evaluations at regular intervals, with possible renegotiation of vendor contracts dependent on performance data, adjusted requirements, or opportunities. Requalify vendors regularly through reaudits and reviews of the documentation for sustained compliance.  

Most leading sponsors have already blazed a trail with advanced models for vendor oversight, driven by centralized governance teams, real-time performance dashboards, and greater use of analytics and automation.  

Scenarios where you must requalify your Vendor 

Contract Renewal or Extension: Review the vendor's compliance standards whenever a contract is up for renewal. Also include the continuous vendor assessment by operations into your check.   

Significant Regulatory Changes: If there have been changes in industry regulations or guidelines that impact vendor requirements, re-qualification ensures continued compliance.  

Significant Changes in Vendor Operations: If the vendor undergoes major operational changes, such as mergers, acquisitions, or restructuring, it's crucial to reassess their capabilities and functionality.  

Major Service Expansion or Changes: When the vendor adds new services or significantly alters existing ones, re-qualification ensures their updated offerings meet the necessary standards.  

Data Breach or Security Incident: Following a data breach or any security incident involving the vendor, a thorough re-evaluation is necessary. It needs to be verified that continuing the cooperation with the vendor does not pose a risk to your business or your study. This case might lead to a stop of the cooperation with the vendor, depending in the results of the root cause analysis. 

End-User Feedback: If clinical teams raise concerns about the vendor's quality, compliance or even general performance, it's essential to initiate a timely re-qualification.  

Expired Certifications or Accreditations: Re-qualify if the vendor's industry certifications or accreditations have expired, to ensure they still meet the required standards.  

Time Lapse Since Last Qualification: Re-qualify at regular intervals, even without specific concerns, to ensure the vendor maintains consistent quality. This interval needs to be defined in dependance on the risk category of the service and vendor criticality.  

New Risks Identified: If new risks emerge related to the vendor's services or operations, a re-qualification can help identify and mitigate these risks.  

Keeping up with these considerations will ensure you only work with vendors that meet the required standards consistently. Re-qualification results will indicate whether the cooperation can continue. 

Regular re-qualification isn't just a box to tick—it's an essential practice for long-term success. 

Vendor Issue Management and Off-boarding  

Even with the best of efforts to handle vendors, problems and underperformance will still rear their heads from time to time. Mechanisms to be set up include timely detection, root cause investigation, and enforcement of corrective/preventive actions to mitigate risk and prevent recurrence. Establish vendor complaint management processes with documented procedures that categorize the severity of issues and require such actions as a result: renegotiation, performance improvement plans, or an independent audit.  

Severe, unresolvable breaches should be the starting point for vendor disqualification protocols. If the relationship with a vendor needs to be terminated, make sure there are knowledge transfer and data migration activities so that the study can be transitioned correctly. Make sure you identify any study records, documentation, or intellectual property that must be retrieved from the outgoing vendor based on agreement terms.  

Effective vendor management spans activities in selection, qualification, contracting, monitoring, relationship development, and quality enforcement. In terms of operations, an organization needs to implement a proactive, quality-focused approach to vendor management since this comes out as a mission-critical strategy for sponsors. But now, with higher regulatory scrutiny and cost pressures across the industry, best practices in robust vendor oversight are not just advisable but an ethical and economic imperative to protect study participants and optimize trial delivery.  

As strategic suppliers expand their roles, sponsors must also strengthen their supplier management capabilities to leverage external collaborations effectively. Use this guide's recommendations and real industry examples to benchmark your supplier management processes against the highest standards. By ensuring you only qualify the most capable suppliers, establish transparent governance mechanisms, and support the development of collaborative relationships so that you realize total value from your supplier contributions consistently and effectively. 

Let our team help you pick the right Third-party Vendors for your study. Get in touch with us today for simple and effective vendor selection and management!

Autor: Dr. Christoph Ortland, September 2024