Complion’s eRegulatory solution is used by KU Cancer Center to manage the regulatory documents for all clinical trials. With the Complion platform, KU Cancer Center is seeking simpler storage, retrieval, and sharing of regulatory documentation and compliant e-signatures to help its regulatory staff members easily manage all related work from wherever they are working.
Additionally, the ability to have unlimited users in the system – PIs, hospital staff, regulatory staff, or external users such as monitors – has made remote or distanced work and review for KU Cancer Center much simpler.
“This integration will not just allow us to be live on SIP, but most importantly, we can greatly reduce, perhaps eliminate, the redundant work to file in another system,” said Joseph Hines II, MPH, Director, Regulatory Affairs for KU Cancer Center. “We also anticipate further reduction in staff time associated with assisting monitors as they will have the information they need quickly and efficiently.”
Perhaps the greatest benefit is KU Cancer Center’s regulatory staff members will not be required to do anything differently than what they are doing today. The regulatory staff will not need to learn or use a different method to file regulatory documents in a different system or be required to identify which documents need to be sent prior to a monitoring visit. As documents are filed following KU Cancer Center’s standard process, the correct documents will be directly available within SIP in real-time.
Complion is assisting KU Cancer Center in developing its best practices for automation and intelligence for the SIP integration based on knowledge gained from KU Cancer Center, SIP, as well as other sponsors and sites. Additionally, this standard process can be reused to streamline the flow of information across other sponsor systems used by KU Cancer Center and updated over time.
About The University of Kansas Cancer Center:
The University of Kansas Cancer Center is transforming cancer research and clinical care by linking an innovative approach to drug discovery, delivery, and development to a nationally accredited patient care program. Our consortium center includes cancer research and health care professionals associated with the University of Kansas Medical Center and The University of Kansas Health System; the University of Kansas, Lawrence; The Stowers Institute for Medical Research; Children’s Mercy; and in partnership with members of the Masonic Cancer Alliance.
Complion is the leading provider of eRegulatory solutions for sites and eISF for Sponsors and CROs on over 14,000 trials. It was founded by a clinical researcher in an NIH-funded medical scientist training program (MD/PhD) in partnership with leading research sites who are among Complion’s customer base like UCSF and Northwestern. With a uniquely singular focus on site regulatory documents and remote monitoring, Complion partners with Sponsors and CROs to contain cost and improve the quality of site monitoring.
The company’s cloud-based software leverages purpose-built site regulatory workflows to intelligently file, find, share, sign, review and collect site regulatory and essential documents. The result – previously redundant, manual error-prone work is eliminated. Complion enables remote work with study management controls that ensure quick access to the right versions of the right documents by the right people. The system uses data stored together with the documents to make searching and finding documents easy – particularly beneficial for monitors.
Complion’s clients include leading Sponsors and CROs, in addition to cancer centers, academic medical centers, hospitals and health systems, multi-specialty practices and dedicated research sites.
Visit www.complion.com for more information.