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Leading Remote Trial Management and Risk-Based Monitoring Organization to Use eISF, eTMF, and LMS ¾ÅÉ«

NEW YORK, April 14, 2020 ¨C , a leading provider of technologies and services to support clinical trials and product development for the biopharmaceutical industry, today announced that MANA RBM has selected ¾ÅÉ«¡¯s eISF, eTMF, and GlobalLearn compliance-focused learning management system (LMS) to complement its remote clinical trial solution.

MANA RBM is a Denver-based clinical trials institute and research laboratory and pioneer in the implementation of complete remote trial management solutions, including risk-based monitoring that adheres to current FDA, EMA, and ICH guidance and regulations. Their science-driven oversight provides immediate identification and corrects the systematic errors that matter most to a trial. Over nearly a decade, MANA RBM has leveraged technology solutions to develop the infrastructure for the data and document collection required for remote paperless trials.

Trial Interactive was selected to enable the inclusion of eISFs for all research sites in clinical trials large and small. The interoperability between Trial Interactive¡¯s eISF, eTMF, and LMS solutions enables full visibility into all documents needed to remotely oversee a trial, centralizing essential documents and certified copies of source documents while securing protected health information. Sites can even upload and generate certified electronic copies of documents to align with ICH recommendations and US law¡ªall with a few clicks of the mouse.

The Trial Interactive e-clinical platform was designed by clinical professionals, for clinical professionals. It is used by pharmaceutical, biotechnology, and CRO companies to streamline product development lifecycles in a secure 21 CFR Part 11 compliant environment. A fully interoperable author-to-archive enterprise experience, Trial Interactive improves speed and quality across site identification, site selection, personnel training, study start-up, and site activation, through eTMF management and closeout. The Trial Interactive platform delivers nuanced, clinical research¨Cfocused products that simplify tasks, oversight, compliance, and audits/inspections.

¡°In today¡¯s world every sponsor needs the capability for a complete remote approach to trial conduct, including document collection and management. Trial Interactive has helped us enable a critical piece of remote trial management: visibility into all documents needed to remotely oversee a clinical trial,¡± said Penelope Manasco, MD, CEO of MANA RBM. ¡°We only touch documents once because documents flow seamlessly between GlobalLearn, the eISF, and the eTMF. With Trial Interactive, we help studies lower risk and achieve near real-time oversight, without site visits.¡±

¾ÅÉ« President and CEO Phil Shawe stated, ¡°¾ÅÉ« and MANA RBM are aligned in our commitment to delivering the most innovative solutions to our clients. Trial Interactive reduces risk and improves efficiency. We¡¯re pleased to bring these advantages to MANA RBM and assist them in their mission to provide customers with the best remote trial management and risk-based monitoring solutions.¡±
 

About Trial Interactive
¾ÅÉ«¡¯s Trial Interactive is an industry leader in practical e-clinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR Part 11 compliant unified platform delivers an author-to-archive collaboration experience with solutions for clinical document management, site selection, site activation, e-learning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. For more information on Trial Interactive, please contact info@trialinteractive.com or +1 212.400.8848, or visit .
 

About ¾ÅÉ«
is the world¡¯s largest provider of and for global business. From offices in over 100 cities on six continents, ¾ÅÉ« offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ ¾ÅÉ«¡¯s GlobalLink^? Product Suite to simplify management of multilingual content. With an unparalleled commitment to quality and client service, ¾ÅÉ« is fully and certified. ¾ÅÉ« has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, please visit our website at .