Time Equals Money in the FDA Drug Submission Process

In 2005 the Life Science Industry spent $51.3 billion researching new drugs. This significant investment demonstrates why the process of moving drugs from development to FDA clinical trials must be efficient and fast. Every day that a drug submission to the FDA is delayed costs hundreds of thousands of dollars in lost revenue potential.

The results of laboratory research, pre-clinical testing, clinical trials, manufacturing specifications, and regulatory paperwork are compiled into enormous documents, often exceeding 100,000 pages. This is a major problem for companies that need to quickly circulate these documents through a workflow process to prepare them for regulatory submission. After the years of hard work that go into each round of testing and trials for drug submissions, delaying a New Drug Application (NDA) due to inefficiencies in the document review cycle is not acceptable.

To meet this challenge, Life Sciences companies should leverage:

  • Ease the burden on corporate infrastructure caused by distributing large documents and minimize end-user time spent downloading documents
  • Incorporate reviewer annotations and commentary into documents without disrupting the review cycle
  • Reduce overall time required to complete Investigational New Drug Application (IND) or New Drug Application (NDA) submissions for the FDA

Overcoming Document Distribution Challenges

Collection and storage of documents required for IND or NDA submission are already managed by enterprise-level document and reporting management systems.  Despite the fact that this infrastructure has been established, delivering documents to users throughout the review process remains problematic. 

One of the main distribution difficulties faced during the review of preclinical test and clinical trial data is the amount of material that has been generated during the years of testing.  Documentation of a single study may take up to 100,000 pages; a full submission includes multiple study results documents.  Each reviewer, even if only needed for a few pages, is typically required to download and search through the entire document to complete his or her step in the process.

Fortunately, document viewing technology resolves many of the common problems faced by companies distributing large documents to users.

  • Server-based processing allows server-side content search and individual page retrieval — eliminating the excessive time required to download large documents
  • Sensitive data is never written or stored on client hard-drives — eliminating security concerns regarding confidential information
  • Web-based viewing does not require files to be stored on local hard drives — eliminating concerns about storage in the end-user environment

Integrating Reviewer Annotations

A major duty of reviewers is to ensure that documents are accurate and complete.  When issues arise, reviewers need the ability to mark-up pages with annotations, questions and clarifications.  Tracking comments independently of the original document typically requires an extra step, often in a separate application. Every extra step in the document review workflow delays NDA submissions from reaching the FDA.

  • Add comments or stamps directly into the document through the viewing application’s user interface
  • Store annotations separately from the document so that it is preserved in its original form
  • Set viewing permissions targeted to user groups defined by administrators

Submitting Drug Applications Early

Using the latest capabilities of Web-based document viewing applications will dramatically improve the efficiency of the FDA Drug Submission Process. Reducing the time required for each reviewer to complete their task, even by a single day, will add up to weeks by the end of the process. This will allow for more time in development and testing, or even better earlier submissions to the FDA. And that, of course, equals more revenue for your company.