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International Clinical Trials
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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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Clinerion is part of Citeline, a Norstella company!
January 30, 2023 – We are pleased to
officially announce that Clinerion has become part of Citeline, a
Norstella company. Norstella is now poised to be one of the world’s
largest pharma intelligence solutions providers on the market.
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PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content
Phlexglobal Ltd
Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive.
As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
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