CRANFORD, NJ – Paragon Solutions will present and exhibit at the 51st Annual DIA 2015, the largest global multidisciplinary event for professionals in the discovery, development and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products. DIA 2015 takes place from Sunday, June 14, to Thursday, June 18, 2015 at the Walter E. Washington Convention Center, Washington, DC.
Paragon’s Michael Agard, Principal Consultant, will present ‘Think Standard Inventory Means Technical Interoperability? Think Again’ during DIA 2015’s session, ‘Mapping the Future for Trial Master File: Advancing Standards by Harmonizing Clinical and Technical Strengths’ beginning at 8 a.m. on Wednesday, June 17, in Room 202B of the Walter E. Washington Convention Center, Washington, DC.
Currently, standardization has become the norm across the clinical research spectrum. The industry has embraced data standards, such as MEDRA, CDISC, and eCTD. The Trial Master File (TMF) is a collection of content that demonstrates that the sponsor conducted the study in accordance with protocol and Good Clinical Practice. In the past several years there has been an industry move to creating best practice and standardizing the Trial Master File content.
Standardized TMF content ensures completeness of regulatory submission, regulatory inspection readiness and trial execution. The TMF standards are evolving to address the interoperability needs of collaboration, mergers, acquisitions, licensing efforts and records retention. This session will discuss the importance of standards in TMF and explore the currently available standards within the industry.
Agard, who joined Paragon Solutions in 2010, is engaged in the architecture and business analysis of eTMF, eISF and portal systems. He specializes in optimizing clinical and regulatory operations for improved compliance. He has experience in Clinical Operations, Data Management, and Clinical Packaging and is active in TMF standards development for DIA and OASIS.
To read Agard’s article, What’s So Interesting About eTMF Interoperability and Why Is It Important? featured on Paragon’s Business Solutions Blog, click here.
Paragon Solutions (BOOTH 2204) Life Sciences R&D team will feature solutions to help Sponsors and CROs increase operational efficiency, lower costs, improve situational awareness and manage risk. These solutions aim to drive a high-performing organization across strategy, people, processes, information and technology.
ABOUT DIA 2015
The DIA 2015 is the 51st Annual Meeting of the largest global multidisciplinary event for the professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products. The Drug Information Association (DIA) was founded in 1964 by a group of 30 pharmaceutical professionals, medical writers and academicians who saw the need to facilitate communications and foster cooperative efforts among professionals working in health care industries primarily engaged in drug development, medical communications and health information. For more information, visit www.diahome.org.
ABOUT PARAGON SOLUTIONS
Paragon Solutions is an advisory consulting and systems integration firm that specializes in enterprise information management to help clients leverage information assets for better business results. Paragon works with businesses that are focused in a few key industries − communications, financial services, healthcare, insurance, and life sciences. The industry-focused practices work with Paragon’s competency groups to address today’s client concerns in Process Optimization, Information Management and Information Integration.
For more information, please visit Paragon Solutions at www.consultparagon.com or call 1.800.462.5582.