TrialAssure Registry is a premiere clinical trial registration and disclosure reporting application with a configurable workflow engine that allows clients to augment regulatory intelligence for over 30 registries, including ClinicalTrials.gov and EudraCT, with internal business processes and custom registries. It allows sponsors and academic researchers to manage the entire disclosure process from start to finish, including registry assessments, validation and quality checks, review cycles, approvals, and comments from regulatory authorities.
“TrialAssure is responding to a critical need of academic researchers including the need for universities to stay in compliance with government regulations in the US and EU, as well as organizations who may be contributing funds to their research,” said Zach Weingarden, Product Solutions Manager, TrialAssure, based at headquarters. “Currently, the FDA has the ability to fine institutions up to $10,000 per day for failure to register clinical trials or post clinical trial results to ClinicalTrials.gov, but has yet to collect for non-compliance.”
“If fines start to be collected for non-compliance with government regulation, universities stand to risk the most,” said Alan Nicolle, Director, Business Development & Business Alliance Partnerships, TrialAssure, based in London.
Research shows that only 11 percent of universities post clinical trial results to the European Clinical Trial Register (EUCTR) within required timeframes, according to a report published in The BMJ. In the US, a study in BMC Medicine reported that approximately only 35 percent of universities have a policy on reporting clinical trial results, while 74 percent do not have an electronic transparency system to manage the required government reporting of clinical trials.
Academic institutions face additional challenges from disclosing late, from scientific journals refusing to publish results or the National Institutes of Health (NIH) withholding funding.
Nicolle added, “TrialAssure Registry is an easy-to-use system that can bring academic institutions that are conducting clinical trials up to 100 percent compliance quickly and easily. It is often the case that the tasks of registering protocols and disclosing results are assigned within individual academic research units instead of through a centralized team. TrialAssure can assist in this case, bringing additional transparency at the institution level through our compliance reporting functionality.”
For more information on the TAP program or to set-up a demo, visit https://www.trialassure.com/contact-us/
TrialAssure is a 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. 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 McLean, +1-734-245-0165