By Ann Neuer
August 24, 2009 | Smart life sciences companies anxious to compress clinical development timelines are moving from a document-centric workflow to a content-centric environment. So says Stephen Bergson, executive vice president, commercial operations of Virtify, a provider of enterprise content compliance solutions.
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| Stephen Bergson |
“The industry is realizing that document management systems produce static documents that are cumbersome and don’t allow for ready re-use. By moving to a content management environment, you can use, re-use and repurpose compliant content across the enterprise instead of developing the same information over and over again,” Bergson explains.He is referring to the trend that along the continuum—from discovery to clinical trials to post-approval commercialization—sponsors are seeking to leverage content by intelligently tagging it and simply lifting it from a central data repository that is created throughout a product’s lifecycle. With that capability, data only has to be developed once and it can be re-used for any number of upstream and downstream purposes. For example, existing information can flow into structured product labeling (SPL) documents, electronic common technical documents (eCTD), and be extrapolated for manufacturing standard operating procedures (SOPs). In addition, if documents have changed since originally created, the user is notified of those changes, and only the latest versions are applied.
Being able to leverage content across the enterprise has real ramifications for speeding product development and cutting costs associated with pre- and post-marketing regulatory submissions. Research suggests that approximately 26% of the cost of bringing new drugs to market is linked to creating content in a compliant manner, so any effort to reduce that percentage will have a positive impact on the bottom line. Bergson remarks, “We believe that with effective re-use of compliant content, we can drop that figure by an order of magnitude.”
Mandates from various regulatory agencies across the globe and greater acceptance of standards are driving the move to compliant content-centric systems. Bergson points to factors such as Health Level 7 (HL7) standards, the Information Technology Plan in the Prescription Drug User Fee Act IV (PDUFA), and the European Medicines Agency’s (EMEA) mandatory use of the eCTD for submissions using the Centralised Procedure, starting January 2010. In addition, required adverse event reporting begins in September 2009, as stated in Section 801(a) of the Food and Drug Administration Amendments Act (FDAAA); and there is the upcoming regulated product submission standard.
To address this complex regulatory environment and to streamline re-use of content, Virtify recently launched Virtx, a Web-based, collaborative enterprise content compliance suite that the company claims is the industry’s first. Virtx offers end-to-end solutions through a series of modules that are out-of-the-box ready, but are also configurable. The Virtx modules include SPL, eCTD, Clinical Trial Disclosure System (CTDS), Upcoming Standards Support, and enterprise eCompliance products that automate collaborative document authoring, submissions tracking, and other functions. The suite has an extensible markup language (XML) backbone, uses Web 2.0 architecture and offers a user-friendly interface that is presented in a familiar Microsoft Word-like format.
With the September 27 start date for FDA’s required adverse event reporting on www.clinicaltrials.gov, and with the anticipation that other regulatory agencies will require this same function, there is particular interest in the Clinical Trial Disclosure System module. “CTDS is hot right now with all of the clinical trial mandates and directives coming from regulators,” Bergson comments.
Repurposing content takes the market in a promising direction. According to Bergson, “Clients are realizing that it is costing them a fortune to develop documents and then have them go into a static environment. With life science mandates extending out to 2015, and with new mandates being developed, transitioning out of a static-document world into a content-centric world is where the industry is going.”