eClinical Supply Chain Management Platform Implementation Requirements

This blog will explore the eClinical Supply Chain Management platform implementation requirements to ensure the successful roll-out of an optimized clinical supply chain.

Any clinical research sponsor can tell you: every clinical trial and every clinical research site is different with unique needs for supplies, shipping, and subject enrollment in order to adhere to the protocol and any other study-specific documentation. Therefore, the implementation process for an eClinical Supply Chain Management (eCSCM) platform needs to be collaborative and personalized to the individual clinical trial and each of the stakeholders.

Implementation Requirements

Whether at the beginning or mid-trial, the goal of implementing an online platform is optimized clinical supply chain management with collaboration, real-time visibility, traceable chain of custody, and guided workflows that support compliance and protocol adherence. To accomplish this, the approach for eClinical Supply Chain Management platform implementation must include the following requirements:

Setting up the Collaborative Workspace
Tailoring to the Protocol and Other Study Specifics
Continuous Process with Frequent Check-ins and Feedback
Flexibility to Incorporate Changes on Demand
Unlimited Platform Training in the Context of the Protocol

Setting up the Collaborative Workspace

Clinical research trials involve a large amount of information and activities, creating the need for communication and coordination of sponsors, contract research organizations (CROs), research sites, labs, and suppliers. In order for the collaborators to effectively work together during implementation, best practices are defined for supplying, shipping, storing, and using lab kits, investigational product (IP), devices, and ancillary and other clinical supplies, and managing biological samples.

An eClinical Supply Chain Management platform implementation must set up a collaborative workspace that provides:

Coordination regarding the best practices for clinical supply inventory and biological sample management
Automatic logging of the actions taken by all collaborators
Alerts pertaining to each collaborator’s role

Tailoring to the Protocol and Other Study Specifics

Every clinical trial is different. Each has unique operational requirements including the protocol, pharmacy and lab manuals, and clinical supply needs. The implementation process for a clinical trial has to capture these unique needs and embed them in the software configuration.

Therefore one of the eClinical Supply Chain Management platform implementation requirements is tailoring the software configuration to the protocol and other study specifics such as:

Procedures that need to be conducted at the various time points
Lab kit and other clinical supply needs
Supply thresholds that define how much inventory each research site needs to maintain and when new supplies need to be ordered
Biological sample collection, processing, packaging, and shipping best practices
Subject visit schedules

Continuous Process with Frequent Check-ins and Feedback

Clinical trials evolve—as do their protocols and related supply needs—as the clinical trial process surfaces new learnings. The implementation process needs to account for this evolution.

Accordingly, one of the eClinical Supply Chain Management platform implementation requirements is that it is a continuous process with frequent check-ins and feedback to discuss:

Kitting configuration changes
Protocol changes and amendments
Collaborator experience with the platform and configuration

Flexibility to Incorporate Changes on Demand

The implementation must be flexible enough to incorporate the input from the frequent check-ins and feedback. In order for the clinical trial schedules to not be negatively affected, these changes in configuration must be able to occur quickly.

It is required that the implementation of an eCSCM platform be flexible enough to incorporate changes on demand such as:

Kitting configuration
Protocol amendments
Collaborator experience with the platform and configuration
New collaborators including suppliers, research sites, and labs
Subject enrollment at the various research sites

Unlimited Platform Training in the Context of the Protocol

It is important that the training of research sites on the protocol is consistent, so that all research sites conduct their procedures the same way. Therefore, it is required that the platform training does not contradict or conflict with the protocol training. It also needs to be available throughout the clinical trial to address research site personnel and schedule changes to keep all of the clinicians working consistently.

It is required that the training for eCSCM platform implementation is:

Provided in the context of the protocol
Offered on an unlimited basis for anyone who needs training, regardless of when they get involved in the clinical trial