Cranford, NJ – May 11, 2012 - Paragon Solutions, an advisory consulting and systems integration firm, will sponsor and present at the Center for Business Intelligence (CBI) conference, 3rd Pharma/Bio Boot Camp on Electronic Trial Master Files. The event will be held at the Hyatt Regency Penn’s Landing in Philadelphia, PA on May 15–16, 2012.

The Electronic Trial Master File (eTMF) Boot Camp provides an educational format for companies to gain an understanding of the methodology required for designing and executing an eTMF, as well as best practices for monitoring, maintaining and managing the system implementation.

The Trial Master File (TMF) contains all of the essential documents related to a clinical trial required by the FDA for compliance. Management of the paper documentation associated with clinical trials has been determined to be one of the most inefficient and costly aspects of conducting the trial. Many pharmaceutical companies are therefore moving their TMFs to electronic systems that provide greater efficiency, increased collaboration and lower storage costs than paper-based systems, and they are seeking direction and best practices to most effectively transition to such a system.

“This has proven to be a very worthwhile and informative event for those in the industry who are challenged with achieving the highest level of TMF efficiency to reduce costs and ensure compliance,” said Paragon Clinical Optimization Practice Director Jamie O’Keefe. “We are happy to be returning again this year to provide our insight and expertise on how organizations can improve on existing processes or transition to a new environment that will provide greater benefits to the organization over the long term.”

Paragon will present two sessions at the conference. On day one, “Developments in the eTMF Platform,” which will be presented by Fran Ross, principal consultant for Paragon Solutions, will address:

  • How processes are improved with an eTMF
  • The different options available
  • An update on the TMF Reference Model

On Wednesday, May 16, Jamie O’Keefe will present, “Industry Benchmarking Session: Real-Time eTMF Survey Results.” The session will unveil the findings of Paragon’s own industry eTMF research, including:

  • Current eTMF process trends
  • Scope of technology in practice today within pharma/biotech companies and CROs
  • Diversity in practice
  • Common challenges in eTMF implementation and management

Paragon’s Clinical Optimization Practice assists life sciences organizations by providing strategy consulting and systems integration services that enable companies to adapt or extend business processes and systems to improve TMF management, reduce costs and ensure compliance.

Paragon is also a sponsor of CBI’s 4th Annual Summit on Clinical Trial Investigator Portals, which is being held in conjunction with the eTMF Bootcamp event.

For more information or to register for the CBI events, visit the conference Website at

About CBI

CBI, a subsidiary of Advanstar, is the leading provider of market-driven, unbiased conferences for the pharmaceutical, biotechnology, medical device and healthcare industries. CBI offers specialized information presented in interactive formats by thought leaders and regulators.

About Paragon

Paragon Solutions is a business and technology consulting firm that specializes in enterprise information management to help clients leverage information assets for better business results. The company does this through its industry practices, solution accelerators and specialized technology competencies that help clients achieve operational efficiency, business scalability and regulatory compliance.

Paragon’s Life Sciences practice addresses the needs of the pharmaceutical, biotechnology, and medical device sectors. Our technology solutions are helping firms respond and capitalize on industry change driven by competition, consolidation, convergence and regulation.

For more information, please visit the Paragon website at, or call 1.800.462.5582.

Erik Raper
Paragon Solutions
(908) 653-3016