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Streamlining Regulatory Publishing with Submission-Ready PDF Files - Articles Surfing


As the business world turns its attention from back office automation to front office efficiency the need to streamline document and information management is starting to play an increasingly important role. This has never been more relevant than in the pharmaceutical industry. Enterprise Content Management applications, eCTD software and other information management tools all provide benefits that are designed to better manage information and streamline document workflows. As much as these applications aid in general contributions to document management, there are still further requirements in regulatory submissions that the generalities of these applications don*t address. The cost of government and regulatory compliance leaves a lot of room for improvement * a key area being the document conversion and publishing process. The real and opportunity costs of non-compliance leave most companies spending an inordinate amount of time and money ensuring document quality and compliance. What if there was a tool that would not only automate document conversion and publishing but reduce the need to perform quality checks and balances? Streamlining the sub mission process not only saves money but it can generate millions of dollars on the back end of the life cycle of the product. This article talks about real-world process improvements, cost reductions and the opportunities for streamlining document submission processes, highlighted by applications with proven track records.

Time to market has always been a critical success factor for manufacturers and marketers of consumer products. But when every day's delay can mean millions against your bottom line * and when your product might mean the difference between life and death for millions of people worldwide * the stakes are that much higher. These are the stakes that leaders of Life Sciences and Pharmaceutical companies must contend with every time a new drug or technology is faced with regulatory approval. For a blockbuster drug like LIPITOR* or NEXIUM*, that are now prescribed in excess of $10 million every day, reaching the marketplace quickly can make or break the financial quarter or even a full fiscal year. High stakes indeed.

The regulatory minefield

For Life Sciences and Pharmaceutical companies, time to market is always held hostage, to some degree, by the global regulatory landscape. Few industries face regulation on the same scale and level of complexity. Such intense oversight and scrutiny is reasonable for an industry of such intricacy and potential impact on the health and wellbeing of much of the world's population. At the same time, the agencies that impose these regulations, like the Food and Drug Administration (FDA) in the United States, face intense pressures of their own.

Recent media and congressional examination of several high-profile cases in the drug industry have put the FDA and its international counterparts firmly on the defensive. This is not good news for the industry. Scandals surrounding first the cardiovascular effects associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and more recently the *sleep driving* and *sleep eating* side effects of popular new insomnia treatments are causing a significant retrenchment within the regulatory community. The FDA in particular is facing growing pressure for congressional action to address these issues but the proposals currently under consideration, in the opinion of many industry players, would harm, not improve, patient safety by making it more difficult to get promising new drugs approved and into the hands of doctors and patients.

The FDA has also been perceived in the past as *cozying up* to the industry and of rushing promising new drugs and technologies to market without an adequate paper trail. The result of this perception, justified or not, is heightened scrutiny, leading the agency to become progressively more conservative and defensive in its decision-making and in its approach to reviewing and approving submissions for new medicines and technologies. At the same time, promising new areas of study such as the Human Genome Project (HGP) are turbo-charging innovation and discoveries in the research community. In fact, the Wall Street Journal recently cataloged over $1 billion worth of currently pending IPO filings and there is a growing collection of existing bio-engineering companies applying HGP concepts in the marketplace.

The combination of more rigorous oversight, increasing threats of litigation and the explosion of complex, technology-driven areas of research have created a perfect storm for companies looking to succeed in this complicated landscape. It has also led to an atomic explosion in the size and complexity of submissions related to new drugs and technologies. Though this cutting edge research is conducted using the latest technology, it is remarkable how often the key results are compiled and maintained on nothing more sophisticated than a series of unconnected MS Word documents and even hand-written forms. Documentation for a single research study may consist of tens of thousands of pages with a full submission including multiple study results documents. Extend this over multiple jurisdictions, different languages, add in the complexity of joint ventures, patent laws, sub-contracting and outsourcing research 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.

Electronic submissions: technology to the rescue?

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 that contributes directly to the bottom line.

Preparing submission compliant documents, typically in PDF, is a time-consuming and highly iterative process critical to successful submissions. As discussed earlier, 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, 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.

Not all solutions are created equal

The excessive size of these submissions is also a significant burden for the agencies themselves. For its part, the FDA plans to streamline and simplify the process by moving all submissions to an automated electronic platform by the end of 2007 * with the caveat that this may be pushed out to a later date. The standard, known as eCTD (electronic Common Technical Documents) is an interface between industry and 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. The specification has set criteria that make electronic submissions technically valid, and any eCTD-compliant submission prepared in any compliant environment can be transferred to another environment built on technology from another vendor. In theory it sounds ideal, however in practice it should be remembered that not all technologies are created equal.

With the FDA demanding the use of the eCTD format, the leading players in Life Sciences and Pharmaceuticals were quick to make the transition; recognizing the opportunity to streamline their own processes and take advantage of the inherent cost savings. 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. These companies have also seen the way the wind is blowing with the news that the European Union has mandated that all 27 member countries be ready to accept eCTD submissions by 2009. Can the chapter of paper submissions be nearing its end? Can the rest of the world be far behind?

There is no shortage of document workflow, rendering and output solutions available but the requirements for eCTD compliant submissions are unique and require an integrated solution that puts the focus where it belongs * squarely on delivering final submissions that can handle the complex, ever-evolving landscape of this leading edge industry. 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.

Software applications, like those offered by Adlib Software, avoid these pitfalls by focusing 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.

Robust rendering is the core

Robust PDF rendering forms the backbone of any document management workflow 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 version control, downgrading, font embedding, automated Table of Contents creation, audit history and submission taxonomy. These PDF documents are also flexible and scalable at every stage of the submission lifecycle, particularly important given the FDA's increasingly aggressive use of post-marketing *risk minimization action plans* (RiskMAPs) * including the requirement to submit additional safety information (such as larger safety studies to screen earlier for relatively rare potential adverse reactions) * after the original submission is made.

The right instruments: powerful, flexible and nimble

When it comes to partnering with leading edge players in Life Sciences and Pharmaceuticals, Adlib Software is uniquely positioned to supercharge the submissions process with its powerful document transformation framework anchored by Adlib Express Server and Express Web Services. For more than 10 years, Adlib as enabled several key industry players to gain a competitive advantage by maximizing the efficiency of document workflows. The difference with Adlib Software's solutions compared to some of the other PDF rendering engines is that Adlib Software cut its teeth working with global Life Sciences partners to ensure that the quality and fidelity of its PDF renditions not only meet but exceed the demands of regulatory submissions.

Several of Adlib's customers have reported savings amounting to millions of dollars with the majority of the direct cost savings coming from substantial QA cycle time reductions due to unprecedented confidence in PDF rendering quality. QA has been reduced to a couple of minutes compared to what used to take hours. Given the sheer volume of document rendering that takes place for just one submission and multiply that by the number of submissions performed each year, the numbers add up quickly. The indirect impact, although harder to measure may even have a greater impact on the bottom line. By streamlining the submission process and providing higher quality submissions, product hits the market sooner. As mentioned earlier, each day gained could be worth millions of dollars in extra sales. Not a bad ROI is it.

With its advanced publishing features and support for multiple formats including MS Office-based sources, Adlib Express Server applications give companies all of the advanced features necessary to significantly accelerate submission compliant document workflows. Some of these features include automated, accurate optical character recognition (OCR) to create searchable files from images and PDFs, stamping to create headers, footers, volume numbers and cross-references from hyperlinks, as well as dynamic Tables of Contents generation capabilities. Importantly, Adlib Express also normalizes hyperlink styles to meet FDA standards and includes advanced bookmarking control with the ability to merge and/or volumize PDFs based on page count, size or other variables. Adlib solutions are XML-ready with XML Job Ticket support and Web services. A truly complete solution.

Adlib Software then takes things to the next level with its Exhibit product. Exhibit enables organizations to leverage existing XML backbones, as well as folder structures for Rest of World (ROW) submissions in either paper or volumized PDF formats. Exhibit works with eCTDs as well as other submission formats (e.g. 510k) and with other applications to provide the ultimate in flexibility and interoperability.

Exhibit was developed in partnership with several world leading pharmaceutical companies to automate the process of creating paper-based submissions from eCTDs. It's a collaborative browser-based solution that optimizes the capabilities of Adlib Express Server to prepare electronic submissions for print or volumized PDF destinations. It includes the ability to convert electronic hyperlinks into paper-based bookmarks and references as well as automated features that allow for intelligent document assembly; modifying Tables of Contents, page scaling, the application of headers and footers, page numbers and the insertion of tabs and slip sheets. All of these advanced operations are available with Express Server but leveraged through applications like Exhibit.

The benefits of a solution like Adlib Express Server is that the scalable conversion, publishing and OCR functionality can be leveraged for not only regulatory submission processes but it can also be applied 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 and Pharmaceutical organizations to take advantage of existing investments in skills and technology to achieve document management efficiencies that truly support the critical work they do on behalf of humanity * and their shareholders. These solutions are also flexible and scalable enough to act as the launching pad for adopting innovative new methods of information management to achieve competitive advantages over time.


Submitted by:

Scott Mackey

For more information about the author, this article subject matter or Adlib Express Server applications, please go to http://www.adlibsoftware.com or call Adlib Software at +1 905 631 2875.



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