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Integration Allows Schulman to Streamline eTMF Filing and Compliance for Life Sciences Clients

 

NEW YORK, November 16, 2015 ¨C ¾ÅÉ«, a leading provider of global development and commercialization solutions to the life sciences industry, today announced that Schulman 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. 

 

¡°Many of Schulman¡¯s clients have moved to an eTMF environment and want an efficient way to have IRB related documentation direct into the eTMF with relevant metadata for auto-filing without human intervention. We chose to integrate with Trial Interactive as many of our mutual clients and potential clients are using the eTMF solution,¡± said Michael Woods, President and CEO of Schulman IRB. ¡°With its automation and global document management capabilities, Trial Interactive helps our customers streamline processes while meeting regulatory requirements, allowing for remote inspections and even faster start-up timelines.¡±

 

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 Schulman IRB as their central IRB. Clients were spending an inordinate amount of time downloading IRB related documents, uploading them to our eTMF, and coding metadata. We¡¯ve now automated that process to take place without user involvement and eliminated the need for users to look at multiple systems, which has always been a challenge for study teams. This integration will also extend to our electronic Investigative Site File (eISF) to streamline administrative work for sites.¡±

 

About Trial Interactive

¾ÅÉ«¡¯s Trial Interactive solution provides a collaborative web-based platform for study start-up and eTMF that enables sponsors, CROs, IRBs, central laboratories, and other vendors to maintain and update clinical trial documentation in a secure online environment. With fully searchable solutions including investigator portals, Trial Interactive streamlines study timelines and reduces the administrative burdens of global clinical trials. As part of ¾ÅÉ«¡¯s Life Sciences division, Trial Interactive is dedicated to working with clients on a global, collaborative level, supporting a wide range of requirements including e-feasibility, eTMF review/reconciliation, eISF, investigator portals, pharmacovigilance and safety management, endpoint adjudication, learning management systems (LMS) and product licensing and alliance management. For more information on Trial Interactive, please contact info@trialinteractive.com or +1 212.400.8848, or visit .

 

About Schulman IRB

Schulman IRB has been a leader in the protection of human research participants in the U.S., Puerto Rico and Canada since 1983. Schulman offers thorough, timely IRB review services ¨C including dedicated review capabilities for all phases of research across all therapeutic areas ¨C to clinical trial sponsors, CROs, investigators and institutions. Schulman also provides global consulting services through its joint venture partner Provision Research Compliance Services, offering comprehensive solutions to improve overall quality standards for clinical studies and data integrity, and to maximize the protection of human subjects. Fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), Schulman has an unparalleled clean audit history with the Food and Drug Administration (FDA). For more information, please visit or follow on Twitter or on .