Verified Clinical Trials, whose technology helps eliminate multiple enrollments by clinical trial volunteers and provides Medicare Secondary Payer Law compliance strategies, will offer its services with SAFE-BioPharma, a global digital identity management and signature standard used by many of the world’s largest biopharmaceutical companies. The company also has joined the SAFE-BioPharma Vendor Partner program, providing it with direct access to decision-makers in SAFE-BioPharma’s member companies.
Eliminating multiple simultaneous clinical trial enrollments improves research patient safety and data quality. Verified assigns a proprietary, de-identified unique identification code to research participants which, combined with other features, tracks participants and the investigational compounds or devices being administered. Incorporating the SAFE- BioPharma standard allows research staff to obtain a digital identity, and the combined service will enable each research patient and trial administrator to apply binding digital signatures to electronic consent forms, patient diaries and other documents.
“Our alignment with SAFE-BioPharma provides Verified Clinical Trials with unique exposure to the SAFE-BioPharma community of companies. Integrating the standard into our service will improve clinical trial efficiencies by eliminating time associated with secure document signing and exchange. It also will reduce trial costs,” said Mitchell Efros, M.D., FACS, president and CEO.
SAFE-BioPharma is a nonprofit industry coalition responsible for the ongoing development and implementation of the SAFE-BioPharma standard. High assurance digital identity credentials based on the SAFE-BioPharma standard are used in the biopharmaceutical and healthcare sectors to sign electronic documents and data files and to authenticate to online applications. Association members include AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Merck, Pfizer, Roche and sanofi.
“The global clinical trial process is undergoing major changes that require more secure and trusted processes. Both Verified Clinical Trials and identity credentials based on the SAFE-BioPharma standard provide intelligent and cost effective alternatives to clinical trial sponsors and CROs,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association.
Dedicated to enhancing patient safety and improving data quality by preventing dual enrollment in clinical trials, Verified provides a worldwide clinical trials database registry and a solution to maintain compliance with the complex Medicare Secondary Payer Law.