Streamlining Regulatory Submissions: Turning Patents into Profits Faster

By Adlib Software

In the life sciences industry, time lost in the preparation of regulatory submissions represents lost money that will never be recovered. While the clock ticks down on patent protections, the standardizing, organizing, rendering and QA of every bookmark and hyperlink literally eats millions of dollars in potential profits, day by day.

Regulatory challenges go far beyond the preparation and publishing of submissions. Document systems that can stand up to regulatory audits require the capture, security and archiving of documents that may include hand-written research notes, graphics, and internal and external memos and correspondence, as well as more standard MS Office documents. These complex challenges multiply as companies gain new software environments through corporate acquisitions, and extend their reach into global operations and global submissions.

These hurdles are not insurmountable. In the world's largest pharmaceutical firms, Adlib^TM software has helped to deliver the following benefits:

• Savings of $8.5 million a year in quality review time in one large pharmaceutical company
• Massive QA reductions in regulatory submissions, typically more than 90 percent
• Expedited international submissions through global submission filings
• Elimination of downtime, research time, and user involvement in document management through background control of jobs, standards, priorities and storage taxonomies

"The extreme demands of the pharmaceutical industry and the valuable collaborations with our customers have enabled us to refine solutions to meet the unique needs of this industry sector," notes Scott Mackey, director of product management at Adlib Software. "We're exceptionally proud of our loyal customer base which ranges from mid-sized to the very largest life sciences firms, as well as the partnerships we've developed with the overwhelming majority of document management firms that serve the life science sector. Adlib technology is embedded in these partners' eCTD solutions."

The challenges
The current regulatory environment reflects the pressures on regulators to deal expeditiously with an ongoing flood of submissions while protecting the public interest. Standards for submissions have progressively tightened in terms of formats and details designed to eliminate ambiguity or errors, and also to control the sheer volume of printed materials.

As some paper submissions became so voluminous as to require trucks for delivery, the FDA moved to mandatory electronic submission in January 2008. Around the globe the move to eCTD (electronic common technical documents), an XML-based structure for high-quality PDF documents, is underway. The percentage of companies still using paper submissions is dropping rapidly.

Despite the increasingly universal adoption of electronic submissions, the conversion of documents from various formats into submission-ready PDFs presents real challenges. Submission-related projects of gathering, organizing, transforming to PDF, and formatting to meet regulatory standards can be radically shortened by intelligent background processes. Such processes include automatically transforming documents to high-quality PDFs, centrally archiving them for easier access, and even pre-formatting and gathering documents into taxonomy-driven archives designed to support submissions.

Different countries have different standards for regulatory submissions, increasing the challenge for multinational firms. In many cases, such as submissions to the FDA, these requirements are rigidly enforced. An FDA review process can come to a complete halt if the tables of contents, hyperlinks or bookmarks do not align to standards, restarting only when the submitting company has corrected the documentation.  The cost of these delays to the submitting company typically runs in the millions of dollars per day. Even worse, bad PDFs can result in the dreaded 'Refuse to File' notice from the FDA adding both direct costs and lost opportunity for the applicant.

Therefore the requirements for a comprehensive solution for converting, assembling and publishing submission-ready content should logically include the following:

• Centralized management and controls
  • Automated and timely processing of all relevant documents
  • Oversight of document conversion processes for security and auditing
  • Integration with business systems to support easy access and organization of submissions
• Transformation of multiple document types, including word processing, scanned handwritten notes, spreadsheets and graphics, to appropriate PDF or other required formats
• Support for global submission requirements
  • Granular control for rapid transformation for  country-appropriate submission requirements
  • Flexible options to  support diverse regulatory standards, including varying paper sizes and varying details for document formatting
• Support for print, electronic and other digital publishing standards.

Such a solution provides benefits well beyond the regulatory submission process. It also provides an infrastructure that supports efficiency across the enterprise, no matter how heterogeneous or globally distributed it may be.

The Adlib solution
Since 1998, Adlib has been dedicated to providing state-of-the-art document conversion and publishing technologies. Adlib Software seamlessly and accurately supports document conversion and rendering in high-volume environments with multiple sources, no matter what the workflow configurations or publishing requirements may be.

Adlib stands alone in several respects, but one of the most important features is its unmatched support of regulatory submission document standards in the life sciences industries, leading to a radical reduction in the time associated with QA reviews. Because of the associated reduction in costs, the return on investment for Adlib systems is typically measured in weeks not months.

Based on customer reports, the manual processes of PDF review and correction are typically reduced from an average of 120 minutes per document to ten minutes. Depending on labor rates and the number of documents rendered, the cost savings are dramatic. The chart below represents average savings from Adlib customers in both large and small firms.

Number of Documents per week	Hours saved Per week	Cost Savings Per week (Based on $60/hr)	Cost Savings Per Year
100	183	$   11,000	$    572,000
500	917	$   55,000	$ 2,860,000
1000	1833	$ 110,000	$ 5,720,000
1500	2750	$ 165,000	$ 8,580,000

 

 

 

 

 

 

"Even greater profits can be found by accelerating the time to submission and the review process of regulatory agencies," observes Mackey. "Most Adlib life sciences customers report faster acceptance levels because of the quality of the submission documents. As a result, they can launch their products faster which helps not only the patients waiting for a solution but their bottom line revenues as well."

The creation of submission-ready PDFs requires attention to a wide set of features and concerns. Adlib has automated virtually every contingency that is faced in creating these documents and meeting regulatory standards. These features include PDF versions, standardized hyperlink styles, embedded fonts, comprehensive tables of contents and bookmark structures. The PDF rendering capabilities are scalable throughout the submission lifecycle, a particularly important feature given the FDA's increasing use of post-marketing risk minimization action plans (RiskMAPs).

Server-based benefits
Another notable feature of Adlib technology is its server-based architecture, which offers broad enterprise functionality. Adlib remains focused on server-based technology at the request of its customers, and the performance and feature set continues to grow with every new version.

One of the largest pharmaceutical firms in the world came to Adlib with a distributed multi-national structure, complicated by numerous acquisitions. The demands for submissions were global. The IT platforms and standards were not homogeneous. The firm wanted to establish controls and standards to streamline the eCTD submission process, as well as provide overall corporate efficiency.

These are the type of challenges that Adlib Express is designed to meet, from developer-level integration issues to the challenges of improving working conditions for researchers and submissions units. In addition to meeting the above requirements for a comprehensive solution, server-based Adlib Express offers the following:

• System performance
  • Scalability and reliability for any level of demand
  • Intelligent cross-platform integration that includes automatic load distribution across multiple Adlib servers
  • Easy integration with any standards-based application or document workflow
• "Invisible" services
  • Background processes requiring no training needed at the desktop level
  • Simplified system administration through automated incident collection
  • Automatic transformation of documents from multiple sources
  • Job management and controls to manage definitions, priorities and ad hoc demands
• Enterprise standards support
  • Transformation of key document formats, including MS Word, scanned images and HTML, with intelligent controls for conversion accuracy
  • High-quality OCR for searchability and accelerated review
  • Support for ISO standard archiving (PDF/A) for easy, long-term document accessibility
  • Extensive publishing features including time stamps, digital signatures, watermarks, headers and footers
• Improved user experience
  • No desktop level visibility or training necessary
  • Improved access to documents
  • Automated support of publishing and expiration of standard operating procedures

This partial list illustrates why Adlib Express is one of the fastest growing document conversion and publishing solutions for life sciences firms and the vendors that support them.

Conclusion
"Adlib Express has been an ongoing success story for us," reports an Adlib pharmaceutical customer. "Our objective in moving to Adlib was shortened submission time. We got that, but we also cleared up many troublesome inefficiencies and improved numerous processes. Adlib Express has paid for itself over and over again."

Adlib Express helps automate document workflows to better support regulatory submission. Unlike many investments in efficiency, Adlib delivers rapid benefits by transparently working in the background to improve every process associated with document capture, transformation, assembly and delivery.

For more information about Adlib Software, Adlib Express or the success stories of Adlib customers around the world, please visit www.adlibsoftware.com.

Contact:
Sales, Adlib Software
T: 1-866-991-1704, E: sales@adlibsoftware.com