Scott Mackey, Director of Product Management
Adlib Software.
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. Nowhere are stakes higher than in the
pharmaceutical industry where a day’s delay can mean millions against the bottom line – and when the product might mean the difference between life and death for millions of people worldwide.
Although Enterprise Content Management applications, eCTD (electronic Common
Technical Documents) software and other information management tools all provide
benefits designed to better manage information and streamline document workflows,
government and regulatory mandates leave a lot of room for increased efficiency.
The Regulatory Minefield
Time 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 Microsoft 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.
Going Beyond Table Stakes
In order to streamline the submission process, the FDA has introduced eCTDs. 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.
The highly collaborative and fractured nature of the research and development process
means that many of the original source documents that make up eCTD submissions need
to be manually reworked. The rework stems from deficiencies inherent in Microsoft 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.
In addition, 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.” However, these improvements must
not corrupt the perfection of the submission. Too often, post-production re-rendering is
where critical errors are made or repeated.
The end goal in preparing an NDA submission is the generation of high-quality,
submission-compliant PDF documents that accurately and precisely represent the source
data. Achieving this goal can be a time consuming and highly iterative process, especially
without the right technology in place.
Submission Ready PDFs – A Proven ROI
Every pharmaceutical and life sciences organization has some submission process
already in place. But, when every day is critical, having leading-edge document
management technologies coupled with collaborative document transformation tools is a
significant competitive advantage. The effective implementation of these technologies
can significantly accelerate submission lifecycles, which contributes directly to the
bottom line.
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.
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. Consider that the manual process of document review and editing can
typically take 120 minutes per document. Automating the document transformation
process can reduce this time to 10 minutes. For a company that submits just 100
documents per week, automating the process can save 183 man-hours per week or
$572,000 per year (based on a salary of $60 per hour).
The cost savings, projected over submissions running into the hundreds of thousands or
even millions of pages, have proven to be enormous.
Steps for Choosing the Right Software
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).
In order to achieve the benefits outlined in this article, organizations should keep the
following tips in mind when selecting their document conversion provider:
• Quality is Key – pick an application that focuses on document rendering quality.
The better the quality, the less amount of time required to review and update
each document.
• Ease of Integration – the last thing you want is to write custom code in order to
introduce a document rendering technology into your infrastructure. Make sure to
choose an application that employs a design philosophy of stable, open protocols
and standards such as XML and Web services, which can fit right into your
infrastructure.
• Natural Workflow – if you want employees to adopt the technology, it needs to
seamlessly fit into the overall document workflow of the organization. Eliminate
any steep learning curves and the rate of adoption will soar.
• Compliance Ready – look for a document conversion application that supports
your regulatory compliant strategy. Not all applications are created equal. Ensure
that the application has a successful history in life sciences – specifically for
regulatory submissions.
• Document Transformation – it’s not enough to bring in a simple PDF
conversion tool and expect all your needs will be met. Look for applications that
have the ability to handle all of your document transformation needs, including;
document assembly, OCR text recognition as well as document conversion. Why
buy 3 or more applications when one will do?
• Scalability and Reliability – the demands of submissions are high. Fluctuations
in volumes coupled with the critical nature of speed to market dictates that you
look for a robust application that can easily scale to meet your needs while
reliably getting the job done with a high degree of certainty and fidelity.
A robust regulatory publishing infrastructure is designed to be a foundation for
growth for life sciences organizations. This critical infrastructure takes advantage of
existing investments in skills and technology to achieve document management
efficiencies that support the critical work being conducted on behalf of the population
– and corporate shareholders. A small investment in the right technology choice can
lead to cost-savings, rapid ROI and faster time to market.
About the Author
Scott Mackey is the director of product management for Adlib Software. He has spent
the last 10 years working with leading companies in the life sciences industry to build
document rendering solutions optimally tailored to meet the stringent needs of this
community. Mackey continues to work with Adlib’s life sciences partners to design better
tools that will eventually lead to more efficiencies and better solutions throughout the
enterprise document management space.