Four Guiding Rules for Embedding an eClinical Qualification Solution.
As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Given that clinical trials in Asia had experienced 30% average annual growth from 2005 to 2012, travel takes up a much greater portion of the study management team’s time and energy. That’s why study teams have turned to technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/distribution and postmarketing studies.
To be successful, site personnel qualification technology must be targeted to each role within the clinical research site. Otherwise, each individual within the site would receive too much or not the right material that pertains to their function within the study. As a provider of clinical site qualification technologies to the Life Sciences industry, UL Compliance to Performance has identified four guiding rules for structuring an automated Clinical Qualification solution within a company’s clinical system architecture.