Tubestop - Vendor Identification

Description

Vendor selection is an important part of the clinical trial process to ensure that the trial is conducted smoothly and efficiently, and that the data collected is accurate and reliable.

There are a number of factors to consider when selecting vendors for clinical trials, including:

The vendor's experience must align to the services to be provided
The vendor's capabilities must meet the needs of the clinical trial, including the ability to provide the necessary resources and expertise.
The vendor's quality and oversight processes.

DCT-specific Considerations/Inputs

In addition to traditional trial requirements (e.g., GCP processes), vendors involved in DCTs need to have experience with remote data collection, patient engagement, and security. Remote data collection refers to the collection of data from patients without the need for them to visit a clinical research site. Patient engagement refers to the process of keeping patients involved in the trial and motivated to complete it. Security refers to the protection of patient data from unauthorized access.

It's a best practice to ensure all the trial handoffs between vendors, study site staff and patients are clearly documented in workflow or other format to ensure alignment on study needs.

21 CFR Part 312 Investigational New Drug Application

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U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024

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U.S. FDA Final Guidance Document: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

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