Background

Our client is a global pharmaceutical company headquartered in Kenilworth, NJ. Our client has over 32,000 employees worldwide and sells product in over 120 countries.

Business Challenge

The Clinical Documentation department Within the Research Institute was drowning in paper. As a result of an increasing number of Phase III studies, the number of case report forms and other study related documentation was growing dramatically A content management solution was needed to manage the high volume of documents created.

Objectives

• Provide a solution to manage the increasing amount of paper
• Provide a solution for generating microfilm for long-term archive purposes
• Provide a solution for generating bookmarked PDF files that the Regulatory group could include in FDA submissions

Technical Solutions

An InputAccel imaging solution was implemented for scanning up to 10,000 pages a day. These images were stored in a Documentum repository and access through a custom PowerBuilder front-end. A custom microfilm module was developed to ensure all images that were put into the repository could be microfilmed with the Kodak ArchiveWriter. A custom PDF export tool was also developed that published multiple case report forms and data correction forms into a single PDF file that was bookmarked by visit, module and discrepancy.

CYA HOTBackup was later implemented to provide hot backups of the Documentum repository to minimize data loss in the event of a disaster.

Results

As a result, documents can now be found much more quickly since they are available electronically. Less office space is needed for storing documents since they can be shipped to long term storage as soon as they scanned.