CRANFORD, N.J.--(BUSINESS WIRE)--
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
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
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 www.cbinet.com/conference/pc11072.
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.
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
For more information, please visit the Paragon website at www.consultparagon.com,
or call 1.800.462.5582.