By Clinical Research News Staff

January 30, 2019 | TrialAssure announced a program called TrialAssure Academic Pricing (TAP) to assist universities globally through managing and disclosing all clinical trial results in a cost-efficient manner.

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.

 Research shows that only 11% 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% of universities have a policy on reporting clinical trial results, while 74% 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.

“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,” Zach Weingarden, Product Solutions Manager at TrialAssure, said in an official statement. “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.”

 TrialAssure’s Director of  Business Development & Business Alliance Partnerships, Alan Nicolle added, “TrialAssure Registry is an easy-to-use system that can bring academic institutions that are conducting clinical trials up to 100% 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.”