Princeton, NJ, August 2, 2017 - WIRB-Copernicus Group® (WCG), a provider of regulatory and ethical review services (IRB) for human research, announced that it has acquired Patient Genesis’ ConsentNow™ eConsent technology.
ConsentNow enables healthcare, pharmaceutical, and medical device companies to share information with patients during the informed consent process. The technology employs custom video and animation segments to educate patients and online knowledge assessment questions to determine their level of understanding. This multimedia experience is delivered directly to the patient using a tablet device at the clinical site.
“Knowledge empowers patients to make the best decisions for themselves and for their families,” commented WCG Chairman and Chief Executive Officer (CEO) Donald A. Deieso, PhD. “Using a patient-friendly format that includes plain language, videos, and animation, ConsentNow helps to ensure that patients truly understand the benefits and risks of their clinical trial participation.”
“In global clinical trials, communication can often pose significant challenges,” added Jeffrey S. Litwin, MD, FACC, CEO of WCG’s MedAvante ProPhase. “ConsentNow enables providers to deliver important information in the patient’s native language and capture their feedback via questionnaire. This helps to eliminate confusion for the patient, and increase efficiency for the trial’s sponsor.” Dr. Litwin co-developed ConsentNow with Kevin B. Kimmel and their team at Patient Genesis, LLC in 2015.
ConsentNow fosters regulatory compliance because it is always loaded with the latest version of the protocol and will not allow the consent process to be completed until all required signatures are in place. With a secure, web-based dashboard, it provides both the sponsor and clinical site team members with real-time access to valuable site statistics.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.