Through the partnership, PCRS Network and Complion will provide: a standardized set of forms and processes customized for the site consisting of the electronic regulatory binder, patient binder and central file for shared files like CVs, licenses, CLIAs/CAPs and more; a single Web-based point of access for PCRS sponsors and CROs to access all sites; a proven transformation process with support based on best practices for Part 11 compliance as well as obtaining sponsor reimbursement and the highest rates of staff adoption for eRegulatory system and activities across all trials; and eSignature facilitation for all study-related documents
In collaboration with PCRS and other leading sites, Complion enables sites to store electronic regulatory binders, patient binders and central files without any paper backup, with advanced security, audit trails, as well as user access on a per trial and role basis.
“We are pleased that PCRS Network chose to partner with us to help sites accelerate adoption and streamline a very inefficient process” said Rick Arlow, Complion’s founder and CEO. “We are revolutionizing the way sites conduct trials. Our customers are meeting increasing regulatory and documentation requirements in less time and with greater compliance. Sites are also differentiating themselves as successful research organizations that consistently meet deliverables and can provide secure remote access and communication tools for their sponsors and CROs.”
In a recent first-of-its-kind survey by CenterWatch and Complion, sites were found to spend more than 255 hours per study managing regulatory and documentation tasks and spend and more than $1,125 on material and archiving costs. Sites that have adopted a standard process and eRegulatory system have been shown to save 40% of the time and 100% of the material and archiving costs—valued at $6,235 in savings per study.
PCRS Network is a network of phase I, II, III and IV sites strategically located throughout the U.S. and abroad. Complion, an Ohio-based eRegulatory provider for sites, was founded by certified clinical research professionals to empower sites.