Cheyenne, WY / Cleveland, OH (PRWEB) December 02, 2015
Investigative sites must comply with rising regulatory requirements at the same time that clinical trial complexity is increasing. To increase compliance and efficiency, sites must move from a separate sponsor-specific process for each study to a standardized format and procedure for all studies.
- 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
- Facilitate eSignature for all study-related documents
“We are excited to partner with Complion to provide value to our Member sites. Our partnership is another step toward meeting our mission to Save and Improve Lives by Accelerating Clinical Research,” says John Neal, Founder and CEO of PCRS Network. “Complion is a leading pioneer in developing an innovative, truly electronic, and easy-to-use web-based solution that is compliant with all applicable Part 11 and HIPAA regulations.”
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,” says 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. We've seen our customers achieve significant growth in trials. We take great pride and responsibility in Complion’s contribution to our clients and appreciate their ongoing feedback that enables us to continue to adapt and grow with the evolving needs of sites."
Complion provides sites:
- A simplified portal for investigators to access the key documents and eSign from their phone or any device
- Automatic integrations enable direct upload of documents and correspondences from existing email systems like Outlook or drag-n-drop from portals
- Integrated eforms for direct storage and entry of sponsor, FDA and site forms from startup through archive
- A self-service portal where monitors can login at one location and access records and communicate across all of their sites
- Workflows, searchability and reports to not only store, but to streamline
In a recent first-of-its-kind survey by CenterWatch and Complion sites were found to spend over 255 hours per study managing regulatory and documentation tasks and spend and over $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. Read the article.
About PCRS Network, LLC
PCRS Network, LLC is a Network of top performing Phase I, II, III, and IV Sites strategically located throughout the U.S. and abroad. The combination of high-quality, high-enrollment, and increased efficiencies make for a winning combination for Sponsors, CROs, and Sites.
Sponsors need to accelerate the clinical research phase of new drug and device development processes in order to minimize the time required to complete clinical research and get qualifying drugs and devices to market. PCRS Network simplifies the process by providing access to Member Sites meeting the highest standards of quality and productivity. PCRS Network affords Clinical Research Sites the opportunity to profitably grow their site by associating as peers with other high performing clinical research site thought leaders across the U.S.
Members are accepted into PCRS Network through a rigorous qualification process designed to ensure that only high-quality, high-performing sites become Members, providing assurance to Sponsors and CROs that PCRS Network Members are top enrollers and meet the highest standards in the industry.
Complion, the leading eRegulatory provider for sites, was founded by certified clinical research professionals to empower sites. In collaboration with leading sites and based on best practices, Complion developed a common standard platform to maintain mission critical site workflows and documentation.