¾ÅÉ«

Streamlining Site Activation and eTMF Filing to Improve Compliance Enabled with Chesapeake IRB Integration

NEW YORK, NY, January 17, 2017 ¨C , a leading provider of global development and commercialization solutions to the life sciences industry, today announced that Chesapeake IRB has integrated its IRB platform with the Trial Interactive electronic Trial Master File (eTMF) and study start-up solution to streamline global trial management for sponsors and CROs. 

Trial Interactive is a web-based, 21 CFR Part 11-compliant platform that eliminates the redundancies inherent in paper-based study start-up and TMF management. By providing real-time access to clinical trial documentation as well as automated status notifications for protocols and investigative sites, the integration reduces the time and costs of manually managing IRB-related documentation. 

CIRBI (Center for IRB Intelligence) is Chesapeake IRB¡¯s completely paperless, cloud-based, 21 CFR Part 11-compliant protocol submission and management platform. CIRBI streamlines electronic submissions for all IRB actions and provides complete and rapid delivery of all IRB data and artifacts through its advanced IRB-CONNECT? technology.

Michael Smyth, General Manager of ¾ÅÉ« Life Sciences ¾ÅÉ«, stated, ¡°We have daily interaction with our eTMF and study start-up clients who use or are planning to use Chesapeake IRB as their central IRB. We have had an ongoing commitment to eliminate inefficiencies in the conduct of clinical trials and the IRB documentation that needs to be rapidly available to allow for faster site activation and ultimately wind up in the TMF is critical. This process to date is still fairly inefficient requiring a lot of manual work and we were easily able to collaborate with Chesapeake, due to their state-of-the-art platform, to eliminate this manual process of getting thousands of documents seamlessly into the Trial Interactive eTMF for our mutual clients.¡±

¡°Many of Chesapeake¡¯s clients are moving to an eTMF environment and want an efficient way to have IRB-related documents automatically transferred into the eTMF with relevant metadata for auto-filing in the right place in real time without a tedious and error-prone process. Integration with Trial Interactive is a great benefit to our mutual and potential clients using the eTMF solution,¡± said Jeffrey Wendel, President and CEO of Chesapeake IRB. ¡°With its paperless process and global document management capabilities, Trial Interactive helps our customers streamline site activation and accelerate start-up timelines while meeting regulatory requirements and facilitating remote inspections. It¡¯s a win for the life sciences industry.¡±

¾ÅÉ« Co-CEO Phil Shawe stated, ¡°Chesapeake IRB has a sterling reputation, and the shared attributes between CIRBI and Trial Interactive represented a significant opportunity for us to collaborate. The result is a robust, paperless solution with a wide range of applications  that will help us to deliver greater value to our clients.¡±

Liz Elting, Co-CEO of ¾ÅÉ«, added, ¡°Any opportunity to make things easier on our clients is something we welcome with open arms. In this case, we¡¯ve been able to work with Chesapeake to produce an integrated solution that will be a game changer in the eTMF and IRB world, and we¡¯re confident that the time and cost savings will be both immediate and significant.¡±