CANTON, Mich. (April 7, 2020) – TrialAssure® – a leading, global software company focused on developing clinical trial transparency tools – announced today that it will offer academic institutions free access to TrialAssure REGISTRY—the premiere clinical trial disclosure reporting application. This offer is limited to the registry configurations for ClinicalTrials.gov, the US Food & Drug Administration (FDA) clinical trial registry, and it includes one upgrade per year, keeping with technological advancements and any US regulatory updates or changes to registry requirements.
Academic institutions can sign up for a TrialAssure subscription specific to this program—at no cost— allowing users free access for up to two years. TrialAssure, in providing access to the REGISTRY application, will ask participating academic institutions to make a commitment to transparency in research, including measured improvements to their registry compliance over a two-year period.
“We want to make sure that every clinical trial is reported in a timely manner, and our goal is to provide the tools to help where the need is most evident – in the academic setting,” says Mohamad Zahreddine, Chief Information Officer, TrialAssure, and member of the Forbes Technology Council. “With our streamlined and intuitive registration and results posting capabilities, academic institutions will have the tools they need to achieve full compliance with applicable government requirements.”
Government regulations in the US and other global health authorities require the registration and subsequent posting of summary results for clinical trials. However, in review of compliance in the US, only 34 percent of clinical trials sponsored by academic institutions and similar groups are likely to be reported on-time, according to AllTrials.
With this free, limited-time academic subscription program, institutions will have up to three professional and 20 reviewer level users within the TrialAssure REGISTRY application. As always with the TrialAssure suite, subscribers will own and manage their data directly and have access to full training documentation. There is no requirement for TrialAssure colleagues to intervene or conduct any activities on behalf of the subscriber, unless the subscriber requests this assistance and facilitation.
“Some may ask why we initiated this program and are giving this subscription away for free,” says Kelly Vaillant, Director, Global Transparency Strategy & Compliance, TrialAssure. “The answer is simple: TrialAssure believes that data transparency advances science and the development of new medicines. As an industry, we have a responsibility and obligation to make information about clinical trials available in a way that protects the patient’s privacy but also allows for the benefits to science. If we can help organizations enhance transparency across their clinical research activities, which is needed, it’s a strong step in the right direction.”
Academic institutions have six months (until October 7, 2020) to express interest in this program. Those interested in gaining a free subscription can fill out this form: https://www.trialassure.com/contact-us/
TrialAssure – the technology arm of MMS Holdings – is an award-winning, global clinical trial disclosure and transparency reporting suite with unmatched experience in helping clients navigate complex regulatory submission and reporting challenges. TrialAssure helps meet regulatory compliance goals through a flexible, scalable, and streamlined platform that regularly adapts to ever-changing clinical trial disclosure requirements. Established in 2009, TrialAssure was built from the ground up as a single, integrated transparency system, and it is continually strengthened by the experience of leading pharmaceutical industry compliance experts. For more information, visit: www.trialassure.com.
Don F. McLean, MBA