The process of conducting a clinical trial generates mounds of paperwork, some of which is kept in a binder as a reference for members of the research team and regulatory authorities that might audit the trial sponsor.
But the regulatory documentation in that binder isn’t always complete or reliable. Since trials often take place at multiple sites, documents might be emailed and revised often, then sent to someone else, making it difficult to track, archive and control access to them.
Rick Arlow experienced that while researching as an M.D./PhD candidate at Case Western Reserve University. He has founded a company that’s just closed $425,000 in seed funding to bring to market a web service born out of those challenges.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
RegulatoryBinder is a document management web service created specifically to save hospitals time and money in managing their clinical study regulatory documentation. It’s a bundled set of services through which research offices can create online binders from templates that meet the FDA’s guidelines for keeping and submitting electronic records to the agency. Clinical trial sponsors can also control user access to the documents through the software.
Similar tools exist for life science companies and clinical research organizations in the form of electronic trial master file solutions, but those aren’t designed to meet the needs of hospitals, Arlow said.
After going through Cleveland accelerator FlashStarts this summer, the startup is hoping to close the rest of a $500,000 seed round by the end of the year. The round is being led by FlashStarts’ venture fund with participation from several angel investors. RegulatoryBinder has also been awarded a $25,000 grant from The Innovation Fund, a pre-seed fund for technology startups in the greater Cleveland area. That should allow it to hire core staff members and ramp up sales and marketing efforts.
Arlow said that RegulatoryBinder has three customers including University Hospitals in Cleveland, and a verbal commitment from a fourth.
