Compliance Requirements For An eClinical Supply Chain Management Platform

There are four categories of requirements for optimizing a clinical supply chain:

• Collaboration Requirements
• Real-Time Visibility Requirements
• Traceable Chain of Custody Requirements
• Compliance Requirements

This paper will discuss the compliance requirements for an eClinical Supply Chain Management platform.

Protocols are becoming increasingly complex, and many require multiple amendments, making protocol adherence more challenging for clinical trials. In addition, federal regulations and bestpractice guidance are constantly being updated. Without automated support for communicating, coordinating, and controlling collaborator processes, sponsors cannot ensure that research sites and other collaborators are adhering to the protocol. This also applies to regulatory requirements and good clinical practice (GCP) guidance. As a result, required safety checks might be missed, biological samples might not be collected, handled, shipped, or processed according to the protocol, and regulatory requirements and guidance might not be followed. This can cause subjects to drop out due to negative experiences, or the elimination of subjects due to protocol deviations, which can risk the clinical trial’s overall success.