Cranford, NJ – October 25, 2011 - Paragon Solutions, an advisory consulting and systems integration firm, will co-chair the upcoming Center for Business Intelligence (CBI) conference, “Pharma/Bio Boot Camp on Electronic Trial Master Files.” The event will be held at The Doubletree Hotel Philadelphia Center City in Philadelphia, PA from November 14 – 15, 2011.

Following an overwhelming response to CBI’s first Electronic Trial Master File (eTMF) Boot Camp event in May 2011, which provided an educational format for companies to gain an understanding of the methodology required for designing and executing an eTMF, the second conference will continue to address the issues faced and strategies employed in shifting Trial Master File (TMF) processes from paper-based systems to electronic.

The 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 their paper-based counterparts.

“Paragon exhibited at the eTMF boot camp in May and found it be an excellent forum for information about eTMFs that was very well received by all in attendance,” said Jamie O’Keefe, director of Paragon’s clinical optimization practice. “We felt it was important for Paragon to partner with CBI as co-chair of this event so that we may play a more significant role in providing organizations that are considering the transition to an eTMF system the information they need to effectively plan for such an implementation,” he said.

O’Keefe will present “Effectively Execute an eTMF by Leveraging Vendor Partnerships” at the conference, a case study that will address the critical considerations made during the vendor selection, setup and execution of an eTMF system to ensure a successful implementation, including:

• An outline of the vendor selection process
• Discussion of how successful partnerships can lead to effective implementation
• A review of best practices in collaborating interdepartmentally during implementation

O’Keefe has led Paragon’s Clinical Optimization Practice in assisting numerous life sciences organizations by providing strategy consulting and systems integration services that ensure a holistic approach to a client’s eTMF deployment. Paragon has enabled companies to improve TMF management, reduce costs and ensure compliance by adapting or extending business processes and systems to increase knowledge sharing, reduce records storage costs, standardize record classification and determine the most efficient migration pathways for existing TMF records.

For more information or to register for the event, 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 Web site at, or call 1.800.462.5582.

Erik Raper
Paragon Solutions
(908) 653-3016