Tubestop - Trial Supplies Management

Description

Clinical trial supplies planning is a critical part of the clinical trial process. Without adequate supplies, a clinical trial can be delayed or even terminated. Clinical trial supplies planning involves identifying all of the necessary supplies, determining the quantity of each supply that will be needed, and ensuring that the supplies are delivered on time and in good condition to the appropriate location.

Some of the key considerations in clinical trial supplies planning include:

The type of clinical trial: The type of clinical trial will determine the types of supplies that are needed. For example, a clinical trial that involves a new drug will require different supplies than a clinical trial that involves a new medical device. Include planning for biospecimen collection and any other trial-specific assessments
The number of patients: The number of patients enrolled in a clinical trial will also affect the quantity and availability of supplies that are needed.
The duration of the clinical trial: The duration of the clinical trial will also affect the quantity of supplies that are needed. Consider expiration of investigational product lots and other supplies needed.
The location of the clinical trial: The location of the clinical trial will also affect the availability of supplies. For example, a clinical trial that is conducted in a remote location may have difficulty obtaining certain supplies.

DCT-specific Considerations/Inputs

Because not all trial assessments occur at a traditional site in a DCT, it's critical to develop workflows to ensure that all necessary supplies are available to patients and investigators at the time and place they are needed. Depending on the trial design and investigational product characteristics, supplies may be distributed to the study locations, whether to traditional sites, alternative site location, directly to patients/participants or a combination of these locations.

Consider whether sufficient time is built into supply distribution plans to ensure all supplies are available to conduct each visit as planned at the agreed upon location. This may be determined by the sponsor, the site and or the patient, and workflows may need to be built for multiple options.

Some patients or sites may need access to data capture devices, study assessment devices (e.g., wearables) and or wifi / internet to participate in the trial. Ensure that a plan is in place to support patients and sites.

Direct-to-Patient considerations, issues, concerns:

Best Practices

TransCelerate Modernizing Trials Frameworks

Patient and Site Device Fulfillment:

Best Practices

TransCelerate Modernizing Trials Frameworks