Project: Treatment Center Data Management Standards

Type: Standards Advancement Project

Partners: the SCB Cell Therapy, Gene Therapy, and Tissue Engineering Working Groups

Description:

As new regenerative medicine products are developed, manufacturers often develop corresponding unique treatment center data management portals. Each new portal has its own requirements, including different login credentials and processes. This can prove overwhelming for treatment center staff, as they try to deal with the administrative burden of interacting with increasing numbers of different portals.

As a result, many treatment centers are forced to limit the number and/or types of treatments they provide to keep the portal administration manageable. This is particularly challenging and concerning for smaller treatments centers with patients that require treatment but insufficient number of staff to effectively handle multiple portal interactions.

A standard in this area will facilitate data management platform interoperability to allow better communication between treatment centers and manufacturers, and ultimately allow more patients to get treatments by reducing the burden on treatment centers.

SCB is coordinating development of a documentary standard on common needs and requirements for treatment center platforms for data management.

Anticipated Availability: TBD

Progress:

(learn more about the standards advancement process)

Established a Working Group: SCB initiated working group meetings to coordinate the standard advancement effort. The working group currently has about 120 members.

Preparing to Draft the Standard: The working group is currently identifying the best scope for the standard and assessing what portal information is common and can be standardized and what needs to be customizable by company.

Get Engaged:

SCB needs subject matter experts like you to join the working group. To help, please contact SCB.