Pharmaceutical

Clinical Trial Document Processing

The Pharmaceutical Industry is one of the most regulated industries in the United States. Subsequently 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 of the intensive journey to drug approval.

The Workflow

Under strict document control standards, information documents are collected from the appropriate governing authority and transported to a local HIPAA Compliant Data-Core BPO Document Management Center. All processes are conducted in a Physically Secure Center. When not in use, hard copy documents are located in a secure and restricted storage area. Electronic files are encrypted and password protected to eliminate access by unauthorized personnel.

Typically the process includes the digitizing, indexing, data capture, coding and merging of any pre-existing electronic files into a variety of encrypted formats for internal review by the Pharmaceutical Firm prior to final submission to the FDA.

Other applications processed includes; Drug Sample Tracking, Survey Processing, Pharmaceutical HIPAA Compliance Form Processing, Rebate Form Processing and other Business Reply Cards.