Clinical trials have the potential to represent the costliest and most time-consuming phase of product development. One study can include hundreds of patients and multiple sites, and sponsors are challenged to accelerate site initiation.
Traditionally, the process of training employees and site personnel on GCP fundamentals, study protocols and even EDC (electronic data capture) technology was conducted using an in-person approach.
However, this approach can be costly as employees and sites become more dispersed. This approach also causes a heavy administrative burden in “capturing” training and qualification records, for auditing purposes.
Sponsors seeking an eClinical qualification solution need to consider integration tools, online forms, eLearning and the ability to capture instructor-led training, such as investigator meetings. For example,
UL clients have relied on ComplianceWire®, a secure web-based system that enables sponsors and CROs to add eClinical training for both employees and clinical research sites:
1. Distribute and capture “read and understood” records related to site personnel for all protocol-related materials;
2. Administer online GCP training courses, SOPs, and other non-protocol items;
With eClinical qualification programs embedded in the clinical ecosystem (which includes CTMS, EDC, etc.), clients have reported on average a 40% or greater reduction in site initiation training costs. At the same time, clients have reported that both employees and site personnel have demonstrated improved proficiency within studies.
The eClinical qualification solution must have the potential to reduce the risks of noncompliance. While much attention focuses on the costs of patient and investigator recruitment on clinical trials, noncompliance with regulatory requirements represents one of the most significant – and unnecessary – risks to a clinical study’s research integrity and bottom line.