Clinical researchers are looking for ways to reduce the operational challenges of clinical trials which can often occur by working with multiple sponsors.
Some of these challenges include working with individual sponsor portals, using disparate processes and numerous platforms — each with a unique login credential – which can all lead to increased probability for error and placing patient safety in jeopardy.
As a result, a Shared Investigator Platform (SIP) integration, which can streamline the interaction with multiple sponsors, has become a high priority for many sites. SIP is designed to bring research sites and sponsors together in one secure, common solution to enable study planning, study start-up, and study conduct activities while reducing staff administrative burden. Further, SIP enables connection to many other technology platforms that sponsors use to conduct their trials, such as EDC, CTMS, eTMF and payment systems.
It’s inevitable research sites will be using SIP in some way, particularly since a few sponsors are mandating its use.
To address this demand, Complion has partnered with The University of Kansas Cancer Center (KU Cancer Center) to develop an initial SIP integration. The integration will provide a single standard method for KU Cancer Center to work across the numerous major sponsors it works with on its clinical research studies. It’s the final step necessary to enable KU Cancer Center to achieve the benefits of faster feasibility as well as securing additional studies by eliminating objections from specific sponsors while becoming favorable for other sponsors seeking sites for their studies.
The goal is for the SIP integration to be made available across all Complion sites, which is a base of more than 14,000 clinical trials.
Joseph Hines II, MPH, Director, Regulatory Affairs for KU Cancer Center explains, “The integration allows us [KUCC] to be live on SIP, and most importantly, greatly reduces, if not eliminates, the redundant work to file in another system. We anticipate there’ll be further reduction in staff time associated with assisting monitors as they will have the information they need quickly and efficiently.”
Perhaps the greatest benefit: KU Cancer Center’s regulatory staff will not be required to do anything differently than what they are doing today. 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 before a monitoring visit. As documents are filed following KU Cancer Center’s standard process, the correct documents are then identified for SIP, are automatically pulled from the Complion platform, and then placed directly into the appropriate location in SIP without ever leaving Complion. The result — documents are directly available within SIP in real-time.
Additionally, the process can be reused to streamline the flow of information across other sponsor systems used by KU Cancer Center and updated over time.
KU Cancer Center uses Complion’s eRegulatory solution to achieve simpler storage, retrieval, and sharing of regulatory documentation and compliant e-signatures to help their regulatory staff 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.
Begin a conversation with Complion to see if a SIP integration is right for your organization.