Premier Research Announces Adoption of eTMF

Trial Interactive Tapped as eTMF Provider

PHILADELPHIA, September 5, 2012 – Premier Research announced today that it will use a new electronic Trial Master File (eTMF) system on all Clinical Development Services Studies. Trial Interactive has been tapped to provide the supporting platform.

 

The adoption of eTMF is the company’s latest investment in its 2012-2013 technology RoadMap focused on three key areas:

• Product development efficiencies for bringing drugs to market faster and at a lower cost, including the adoption of next-generation technologies such as Cloud Optimization (SaaS and PaaS), Collaboration Portals, “Bring your own device” Networking, etc.
• Project transparency for customers to better understand trial status and movement, including data integration across platforms, efficient data access, and cross-trial analytics.
• Enhanced paperless, electronic environments for improved operational efficiencies supporting customers and internal teams, including eTMF, eDocument collaboration, and workflow management products.

The adoption of eTMF specifically allows for better project management through real-time access to study documentation. Key advantages of eTMF include:

• Built-in document quality control. Secure compliance with 21 CFR Part 11
• Easy customization to customer processes, language, and preferences.
• Efficient TMF transfer at study conclusion.    

“The eTMF system will significantly improve efficiencies in managing final documentation by allowing our organization to store all final Trial Master File (TMF) documents electronically in a secure and regulatory compliant manner within a ‘Study Room’ accessible to internal team members and customers,” said Premier Research Group’s Krista Armstrong, Ph.D., Vice President, Clinical Development, North America. Over the next months, the company will announce further enhancements to its technology infrastructure as part of the evolution of its CRO offerings.

About Premier Research

Premier Research is a leading global contract research organization (CRO) serving biotech, pharmaceutical, and medical device corporations. Its services include clinical research and regulatory outsourcing in the areas of analgesia; neurology; infectious, cardiovascular, and respiratory disease; dermatology; and oncology. The company also has a wealth of experience in medical devices and pediatric research. Visit Premier Research at www.premier-research.com.

About Trial Interactive

TransPerfect’s Trial Interactive solution provides a collaborative, web-based platform for clinical development that enables sponsors, CROs, IRBs, and other vendors to maintain and update clinical trial documentation in a secure online environment, adhering to global regulatory requirements. With fully searchable solutions including investigator portals, Trial Interactive streamlines study timelines and reduces the administrative burdens of global clinical trials. As part of TransPerfect’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, study start-up, eTMF review/reconciliation, mobile applications, learning management and document management systems, investigator portals, pharmacovigilance and safety management, and endpoint adjudication. For more information on Trial Interactive, please contact info@trialinteractive.com or +1 212.400.8848.

About TransPerfect

TransPerfect is the world’s largest provider of language services and technology solutions for global business. From offices in over 90 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 4,000 global organizations employ TransPerfect’s GlobalLink® Product Suite to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, please visit our website at www.transperfect.com.