Data Management & Biostatistics

Premier Research Announces Adoption of eTMF System

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 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 device and pediatric research.

Premier Research has 21 offices (seven in North America, 14 in Europe) and operates in 23 countries. It employs 1,000 clinical professionals dedicated first and foremost to fulfilling each client’s requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.