Implementing an electronic regulatory binder at your site may seem like a daunting task. Yet with increasing costs and excessive use of space associated with paper binders, the benefits of going paperless are undeniable.
The goal of an electronic regulatory binder is to enable fast and efficient work, eliminating time-consuming administrative tasks, such as printing, scanning, faxing and filing. In a 24-month study, it’s estimated that 255.5 hours of staff time are devoted to regulatory tasks per single study. That’s 255.5 hours that could have been spent by study staff recruiting participants, overseeing laboratory procedures, collecting and reporting data, and much more.
There’s also the added effort of getting the investigator signature for essential regulatory documents. PIs are challenged to balance the demands of their practice with the added workload associated with clinical trials. Undoubtedly PIs welcome any efficiencies for tasks, such as signing regulatory documents. Switching to an electronic binder also eases the burden for regulatory coordinators who are tasked with tracking down those valuable PI signatures.
Electronic Storage = Easier Access to Documents
Storing your binders in a cloud-based location means that your documents can be accessed at any time, from any location. Rather than rummaging through shelves and storage rooms filled with paper binders, you can easily access your essential documents from a laptop or tablet. Cloud-based storage gives you the confidence of always knowing your files are digitally backed-up.
Remote access is especially beneficial for CRAs who are tasked with overseeing the progress of multiple clinical trials. 50% to 70% of their job is spent traveling from site to site to meet with study coordinators and PIs. Remote access to regulatory binders enables CRAs to communicate more efficiently with sites and focus on more critical study related activities.
Regulatory binders are expensive. Between print materials and the cost of your staff’s valuable time, it’s estimated that $13,901 is spent per study in a 24-month clinical study.1 Two studies cost $26,182, three studies $39,273, and so on and so forth. That amount adds up quickly.
With changing regulations to Part 11 and ICH GCP E6, security of systems is extremely important. Moving to a compliant cloud-based electronic regulatory binder system allows the site to control who sees what and when. Full audit trails store all the information of access to the system and documents. With role-based access, the site is always in control!
To learn more about MedPoint Digital’s electronic solution for regulatory binders, RegDoc eSafe®, click here.