The regulatory minefieldTime to market is often held hostage by the global regulatory landscape but few industries face regulation on the same scale and level of complexity as Life Sciences companies. It is surprising then how often the key results of research are compiled and maintained on nothing more sophisticated than a series of unmanaged MS Word documents and even hand-written forms. Submission Documentation often consists of hundreds of thousands of pages. Extend this over multiple jurisdictions and languages, add in the complexity of joint ventures, patent laws, sub-contracting and outsourcing research to CROs and it is hardly surprising that some FDA and EMEA (European Medicines Agency) submissions were traditionally delivered not by the box load but by the truck load.
Gaining an Unfair Advantage
When every day is critical, ensuring that you have effective regulatory submission processes and technologies in place is “table stakes”. Having leading-edge document management technologies coupled with collaborative document transformation tools, on the other hand, is a significant competitive advantage. The effective implementation of these technologies can significantly accelerate submission lifecycles, which contributes directly to the bottom line.
Preparing high quality, submission compliant PDF documents can be a time-consuming and highly iterative process but they are critical to successful submissions. The highly collaborative and fractured nature of the research and development process means that many of the original source documents that make up the submission need to be manually reworked. The rework stems from deficiencies inherent in MS Word or the rendering process itself, particularly the inability to retain key navigation information during conversion to PDF. This kind of manual rework is time-consuming, prone to error and, not surprisingly, very expensive. These deficiencies can be overcome during the PDF creation process by having the right technology in place.
The FDA has introduced eCTDs (electronic Common Technical Documents) to streamline and simplify the submissions process. The eCTD standard - which will soon evolve to RPS (Regulated Product Submission) is an interface between industry and the agency for transferring regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission.
Even companies not required to make eCTD compliant submissions are seeing the advantages of an electronic workflow in accelerating time to market. They are finding ways to leverage the technology and transform eCTD into suitable printed CTD. The European Union has mandated that all 27 member countries be ready to accept electronic submissions by 2009. Finding the appropriate technologies to handle both electronic and print requirements is a challenge.
The documents for an Investigational New Drug Application (IND) or New Drug Application (NDA) submission are always “in play” – constantly under review, endlessly annotated and eternally being “improved”. These improvements must not corrupt the perfection of the submission, which is often the result of post-production re-rendering where critical errors are made or repeated.
Submission Ready PDFs – A proven ROI
Robust PDF rendering forms the backbone of many document management workflows and is the lifeblood that flows through the entire eCTD submission lifecycle. By creating higher quality renditions, quality assurance churn can be reduced to only minutes per document. This is a significant process acceleration over traditional QA cycles – searching for missing, broken and invalid hyperlinks – that usually takes hours to complete. The cost savings, projected over submissions running into the hundreds of thousands or even millions of pages, have proven to be enormous.
Submission-ready PDFs are infinitely flexible and contain an almost limitless set of features. These PDF outputs can be readily equipped with essential elements like access control, standardized hyperlink styles, embedded fonts, comprehensive Tables of Contents, audit history and Bookmark structures. These PDF documents are also flexible and scalable at every stage of the submission lifecycle, particularly important given the FDA’s increasingly assertive use of post-marketing “risk minimization action plans” (RiskMAPs)
Software applications, like those offered by Adlib Software, focus on document rendering quality while employing a design philosophy of stable, open protocols and standards such as XML and Web services. Adlib’s document transformation technologies streamline the rendering process for documents being used in the submissions process. By integrating seamlessly into the document workflow, any source document can be easily rendered automatically into a submission-ready PDF.
Although many of Adlib’s customers are reporting savings in the millions of dollars by applying these applications to the submission process, the benefits of a solution like Adlib Express Server is that their scalable conversion, publishing and OCR rendering functionality can be leveraged across the entire enterprise to create a complete rendering framework for all sorts of document workflows. The robust infrastructure of Adlib Express Server is designed to be a foundation for growth that allows Life Sciences organizations to take advantage of existing investments in skills and technology to achieve document management efficiencies that support the critical work they do on behalf of the population – and their shareholders.
About Adlib Software
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