In CRO, Phase 1 Clinical Trials

Clinical Trial Blogs for Early Phase CROs: Effective Supplemental Vendor Management for Phase 1 Trials—Qualifying Vendors

In this pair of clinical trial blogs, we will evaluate the use of supplemental or specialty vendors in Phase 1 Trials. In this first article, we will take a deeper look into how supplemental vendors should be qualified to ensure trial success.

It’s unlikely that a single early phase CRO will have every possible service or solution under one roof—and that’s completely acceptable. Some procedures or equipment needed for Phase 1 trials can be very specific, and it would be unrealistic to expect that a single site possesses all the necessary components for every use case or scenario.

Below are examples of equipment or procedures that are commonly outsourced (or performed off-site) in Phase 1 trials:

  • MRIs
  • X-rays
  • Biopsies
  • Telemetry
  • Ultrasounds
  • Pap smears
  • Cell isolation
  • Laboratory tests
  • Holter monitoring
  • Ophthalmic assessments
  • Assessments involving scopes or cameras (such as invasive nasal exams or colonoscopies)

When outsourcing is required in Phase 1 trials, it’s important that the early phase CRO perform due diligence to examine the way sub-contracted vendors or partners are assessed and how the relationship between them will impact the study. Evaluating this relationship closely can serve to prevent mistakes and interruption during trial conduct.

Vendor Qualification

As a dedicated early phase CRO, our experience demonstrates that one of the most important aspects of vendor qualification is not just that it is performed at all, but that it is performed by the right person or team. While we advise involving your organization’s Quality department in the process, if the end-users of the service aren’t involved, there are bound to be gaps in information and its possible that significant items will be missed when assessing a vendor’s capabilities to perform the services required by the protocol.

Qualification should be as comprehensive as possible for the services requested. The level of qualification needed will vary based on the impact that the vendor will have on a study. As a result, the information collected will also vary, and the unique questions asked of specific vendors won’t always be the same. Typically, those vendors which are directly generating study data will have the most comprehensive qualifications.

Nonetheless, certain pieces of information are commonly collected across most vendors or service providers for Phase 1 trials:

  • Licensure and certifications
  • Reporting structure, issue escalation flow, and contingency planning measures
  • Resourcing and the ability to accommodate high-volume
  • Ability to meet deliverables within pre-determined timeframes
  • Internal SOPs and workflows in compliance with industry regulations (e.g. GCP, ICH, CFR)
  • Contracting and negotiation process
  • Experience with similar projects

Below is a snapshot of what a qualification questionnaire might look like on paper:

In the next of these clinical trial blogs, we’ll discuss how early phase CROs can ensure that relationships with vendors are managed in a way which will set the foundation for Phase 1 trial success.

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