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.
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:
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:
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:
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:
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:
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:
Since clinical trials, their protocols, and clinical supply needs are dynamic, the eClinical Supply Chain Management platform implementation requirements include:
The overall value of an eClinical Supply Chain Management platform is the optimization of clinical supply chain management. Read our previous blogs to find out more:
Or unlock our Clinical Supply Chain Management Toolkit.
The Slope eClinical Supply Chain Management platform was developed and designed to be implemented as described above.
Contact us to talk to one of our clinical trial solutions experts to see a live demonstration.