Successful and Effective Vendor Relationships

There is a tremendous amount of pressure on Sponsors to develop and test ground-breaking treatments. As a result, execution of a clinical trial requires a tremendous amount of planning and collaboration to ensure all aspects of the trial are completed successfully. With that said, Sponsors must outsource key processes to external vendors. Depending on the size of the Sponsor and level of in-house resources to support all clinical trial activities, vendor relationships become increasingly important.

External vendors are subcontractors that are independent from the Sponsor. They are individuals or companies hired to perform clinical trial related activities including: interactive voice/web response system (IXRS), electronic diary (eDiary) for home visit/diaries, sites, central lab, specialty lab, material printing, monitors, home visit nurse, PK/PD, imaging, coding, and translation services. Vendors are selected shortly after the decision to conduct the study and prior to protocol finalization to ensure they are properly aligned based on the clinical trial needs.¹

As discussed in my October 2021 post 'Advantages of Working with a CRO,' even though there are many benefits to outsourcing to external vendors such as a CRO, there are also many challenges with this approach which include: ensuring efficient data exchange, managing multiple contracts, successful technology transfer, reliable and consistent product delivery, and adherence to timelines.²

To combat these challenges, Sponsors must focus on the essential aspects of the clinical trial to ensure the vendor clearly understands deliverables and internal capabilities required to complete the tasks at hand. These include but are not limited to:

• Evaluating project scope
  • For product manufacturers, this may include details such as scale of manufacturing, testing requirements, specification for the product, packaging, labelling, and shipping.
  • For database developers, this may include database design, user-acceptability testing requirements, and drug dispensation needs.
  • For central labs, this may include kit creation, packaging and shipping based on site needs, database builds, and sample analysis.

• Assessing core and technical capabilities
  • External vendors should perform an internal audit before agreeing to support a clinical trial to ensure that the vendor's capabilities meet the sponsor's deliverables prior to the finalization of the contract.³
  • Vendor flexibility with urgent requests and/or changes is also important to establish upfront given the complex nature of clinical trials.

• Budget and timelines for the deliverables
  • Be upfront about timelines and expectations. Setting a clear expectation from the beginning will help both the Sponsor and the vendors stay on track to meet time-sensitive benchmarks.³
  • Ensuring timelines are clear and realistic will help prevent losing valuable time as you approach initial enrollment milestones.⁴

• Communicate exhaustively
  • A successful collaboration and partnership between the Sponsor and vendor enables trials to move forward with fewer barriers, thus saving the Sponsor time and money. The vendor must be as communicative as possible regarding the previously discussed points to ensure the overall drug development program goals are supported.

Managing a multiple-vendor clinical trial although essential can be extremely challenging. Because clinical trial complexity varies from one protocol to the next, the task of managing vendors is no easy task.⁵

Prior to starting a clinical trial, the Sponsor should select the most appropriate vendor based on the project scope, core and technical capabilities, and budget and timelines for the deliverables to avoid costly delays, conflict, and miscommunication.

Sponsors understand that vendors are experts in specific clinical trial activities, but open lines of communication should be maintained between Sponsor and vendor to ensure success over the course of the clinical trial lifecycle. This will help
promote effective problem-solving if issues arise to keep forward progress through the clinical trial.

Involving all potential personnel in the planning stages of the clinical trial as early in the process as possible will help identify those best suited for execution of the clinical trial activities. In the end, all these efforts are rewarded
with a seamless and effective vendor-teaming for the Sponsor and the chosen study sites.⁵

About the author

Jenna Brager, PhD, RN, MS, is the director of regulatory affairs at MyMD Pharmaceuticals^®. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins
Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.

Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email [email protected].

References

1. https://scdm.org/wp-content/uploads/2020/01/GCDMP-Vendor-Selection-and-Management-2020-Edition.pdf
2. https://tnfpharma.com/news/how-to-avoid-clinical-trial-delays-due-to-budget-negotiations
3. https://www.pharmamanufacturing.com/articles/2018/vendor-selection-and-management-from-a-small-pharma-perspective/
4. https://www.clinicalleader.com/doc/rules-for-managing-relationships-with-your-cros-and-other-vendors-in-clinical-trials-0001
5. https://scimega.com/looking-for-key-strategic-vendor-management-strategies-for-clinical-trials/

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