How to connect WCG IRB Connexus and WCG Velos eResearch CTMS with your eReg/eISF
Are delays in site initiation visits (SIV), first person / first visit (FPFV), and delays in getting studies closed creating unnecessary bottlenecks and frustrations running a clinical research study? Is the lack of visibility and control frustrating your ability to monitor the actual trials and the sites? Choosing the right tools to manage your clinical trial process, especially those that can integrate across your clinical trial, is paramount.
The Bottleneck Challenge
Sponsors, CROs, and Sites are often faced with many bottlenecks and challenges during the clinical trial process – from ineffective site monitoring to a lack of visibility and control into sites, not to mention the ever-present risk of delays in study start up and close out. In addition, there are many requirements for a principal investigator to be in compliance that are required to be checked prior to SIV and site closeout.
An effective eISF solution can not only overcome these bottlenecks, but also ensure your trials are on-time to submission. Moreover, choosing a ‘best of breed’ solution can offer the most robust and easy to use tool for the task at hand, especially one that can integrate with existing tools and systems.
Take for example eISF (Investigator Site File). These eISF solutions connect all the requirements needed for investigators to be compliant to start seeing patients and close out. During this stage of the process, the IRB is submitting documents over to the eReg/eISF solution. A typical clinical research study shares dozens of documents across multiple systems, from Protocols, Amendments, Investigator brochures, CVs, and Informed-consent forms.
Without effective integrations, this process can be very manual and duplicative, wasting precious time and increasing the likelihood of errors due to too much repetitive human intervention. Managing these trial documents in a single place increases efficiency for both regulatory and clinical teams.
Real World Example
Complions’ eReg/eISF Platform integrates with WCG IRB Connexus. This integration enables WIRB-Copernicus Group Customers to securely submit and track the management of IRB documentation throughout the entire clinical trial process. Any site globally is a single click away from connecting Complion to all of their WCG IRB protocols on Connexus. In addition, sites can quickly and easily turn on this integration without any custom setup. Sites can now have a seamless way to manage and direct their cIRB documentation electronically into their own eISF.
Studies are accelerated by ensuring sites are inspection-ready with and notified of approvals, correspondence, and key protocol documents from WCG IRB. Additional benefits include more effective remote site monitoring, easier site adoption and sponsor oversight by eliminating manual processes to move documents from IRB to eISF.
The integration also provides a seamless end-to-end user experience and eliminates redundancies for leading academic medical centers, hospitals, research networks, and independent sites using WCG Velos eResearch CTMS (as well as other site CTMS).
Further, sites realize improved access to information related to patient safety and study conduct with easy clinical staff access to key study documents in WCG Velos powered by Complion and its WCG IRB connection. You can learn about how to integrate WCG IRB Connexus and WCG Velos eResearch CTMS by downloading our data-sheet, here.
Sponsors, CROs, and Sites are in need of control and visibility of investigator compliance to ensure that clinical trials will be on-time to submission. Choosing a best of breed solution that can connect all the pieces within the clinical trial process to ensure clinician compliance without delay is essential.
Complion connects your clinical trial ecosystem through a large and expanding library of re-usable and pre-built integrations to common systems, like WCG IRB Connexus, to accelerate site startup and closeout, reduce redundancies and manual effort.