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vendor contracting

Service agreements with study vendors

The success of a clinical trial very much depends on the performance of critical study aspects by the different parties involved. Proper vendor contracting can make all the difference.

As a Sponsor…

You are responsible for compliance of applicable laws and regulations in the conduct of your clinical trial, and as such need to ensure that your vendors are performing their services in a way that support this compliance.

Further, it is of utmost importance that the study is performed in accordance with agreed timelines and other parameters, to control quality and costs. Furthermore, setting a clear division of roles and responsibilities for the parties involved in your clinical study is an ICH-GCP requirement.

An important tool to achieve this is your vendor agreement.

As a CRO…

It is also critical to comply with applicable laws and regulations and properly manage your vendors as part of your services.

Why properly drafted and negotiated vendor agreements are important:

  • Possibility to think about set-up and potential pitfalls upfront
  • A clear division of roles and responsibilities (ICH-GCP)
  • Compliance with applicable laws and regulations
  • A solid foundation for the collaboration
  • Manage expectations
  • Tools to assess and correct quality and progress

Examples of vendor agreements that Salvius can support with for both Sponsors and CROs:

  • Sponsor – CRO contract
  • (Central) laboratory agreement
  • Pharmacy agreement
  • Meeting planner agreement
  • Consulting agreements (e.g. medical writing, pharmacovigilance)
  • IMP vendor agreement

Complete vendor management

The combination of solid vendor contracting and good vendor management and oversight results in the best outcome for your clinical study. Salvius is in this context collaborating with its alliance partner LUMIS Life Science Consulting to combine the best of both worlds.

Having your overall vendor management well arranged can make a tremendous difference for the success of your clinical trial. Preferably at the front end, but also in the course of the study conduct to get the process back on track or critical issues resolved.

Also see LUMIS