The Pharmaceutical Industry is one of the most regulated industries in the United States; consequently each step in the drug development process must be meticulously documented. Electronic and paper files representing multiple years of development and clinical trial research must be carefully organized and integrated into a meaningful and comprehensive electronic history for submission to the FDA in the early stage review in the long journey to drug approval.

Client
Major US & European based Pharmaceutical Firm.

Outsourced Process
The Digitizing, Indexing, Keyboarding, Coding and Merging of pre-existing electronic files into a variety of encrypted formats for internal review by the Pharmaceutical Firm prior to final submission to the FDA.

Volume
An entire submission program may consist of millions of hard copy and/or electronic pages.

Time Period
Since 1995

Process Description
Under strict document control standards information is collected from the appropriate governing authority and transported to a local HIPAA Compliant Biz-Core Document Management Center. All processes are conducted in a Physically Secure Center; when not in use hard copy documents are located in a locked & restricted storage area, electronic files are encrypted and password protected to eliminate access by unauthorized personnel.