Icon has launched a new, paperless solution for managing the clinical investigator financial disclosure forms mandated by the FDA.
The Dublin-based contract research organization’s Firecrest Financial Disclosure software allows sponsors to electronically gather, distribute, track and manage completion of the forms, required under 21 CFR Part 54, ahead of the study start-up process.
Icon hopes the system will lower the risks of regulatory noncompliance and reduce administrative costs compared to traditional distribution and tracking, the company said in a statement.
“We estimate the solution is capable of delivering savings in excess of 50% when compared to traditional methods, while also contributing to the environmental sustainability targets of our clients,” said Mark Connolly, vice president for Firecrest systems at Icon.
Icon developed the software to address ongoing compliance challenges in the industry due to incomplete forms, the company said.
Icon first acquired Firecrest Clinical in 2011, and now offers a suite of web-based software including electronic consent forms and biometrics, patient prescreening, document tracking and site staff training and guides.