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International Clinical Trials

Bridging the Divide

The exacting nature of regulatory submissions requires an organisation to maintain immaculate documentation that conforms to consistent and stringent configuration and organisation guidelines. Now, more than ever before, the use of technology is no longer a useful option, but a veritable necessity. Pharmaceutical and biologics organisations managing their product submissions and registrations rely heavily on content generated from clinical trials, making document management a critical component of these technological dependencies. The need for having industry-wide consistency of the management of these activities has resulted in the development of industry best practices such as the electronic document management (EDM) for electronic common technical document (eCTD) and trial master file (TMF) for clinical reference models maintaining clinical trial content in conformance with regulatory guidelines.

Connecting the Dots

The EDM reference model is a best practices reference that helps companies provide consistent naming, metadata, and documentation collections within a common structure industrywide. It is a document management initiative aimed at developing document organisation best practice based on eCTD to be shared by pharma and biologics organisations as a common starting point for building sustainable, shareable EDM repositories. The genesis of the EDM reference model was a direct result of technological improvements coinciding with and spurred by the ever-changing eCTD standards for metadata, XML navigation, study-tagging files (STFs), and regulatory information management (RIM). Because document management is a critical component of these technology dependencies, a model was needed to help organisations meet such demands in documents, taxonomies, and metadata. In an attempt to standardise these processes industrywide, members of the Drug Information Association (DIA) and Documents and Records Special Interest Area Community (SIAC) responded by forming a working group in 2008 to develop an EDM model “for the industry, from the industry, and by the industry” (1). The group’s aspiration was to develop a free, open, and sustainable model that would be flexible enough to allow every company to choose the software that would best meet their business needs.

“The goal of the EDM Reference Model is to provide a starting point to create harmonisation across the industry, making it easier for transactions between companies – because the architecture is the same,” EDM reference model core committee member Steve Scribner explains in the Guide to the DIA EDM Reference Model, Process Zone: Regulatory-Submissions (1).“ Even if data isn’t exactly the same, getting people to work together would be so much easier with a model.” The intended audience for the EDM reference model includes biopharma companies implementing an EDM system or a simple file share to store and prepare documents for regulatory submissions of drugs and biologic products intended for human use.

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Patricia Santos-Serrao, Regulatory Affairs Certification (RAC), started her life sciences career in 1994 at Schering-Plough in Kenilworth, US, and later joined Boehringer Ingelheim Pharmaceutical in Ridgefield, US. Within both organisations she took a leading role in transitioning business processes, document management, and submission compilation from a paper to an electronic system. She is a member of Regulatory Affairs Professional Society (RAPS) and also earned her RAC from RAPS and the Regulatory Affairs Certification Board.
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Patricia Santos-Serrao
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