PHARMACEUTICALS

A major pharmaceutical company located in New Jersey was a bind, literally. Access to clinical trial records was slow and inefficient. FDA submissions took hours, if not days, to retrieve from central file. When a staff member wanted some specific information regarding a past product, they would have to search through heavy paper binders, which was often quite time intensive. In addition to the slow retrieval time, central file could no longer house all the files, so valuable office space was being used to store PAPER.

This pharmaceutical company approached File-X regarding their need for document imaging. Expert Technical Consultants from File-X visited the facility and worked hand-in-hand with staff members to devise the most appropriate document imaging solution. File-X was to prepare, scan and re-prep 1.5 million pages of FDA submissions the company needed electronic access to. To accomplish this, File-X set up an on-site scanning station and staffed it with File-X employees. These employees were responsible for the prep, scan, and re-prep of the security-sensitive documents. Back at headquarters, File-X staff members indexed the electronic documents and inserted electronic “bookmarks” and “hyperlinks,” which allows for easy navigation of the final electronic documents. In addition to being able to navigate using bookmarks and hyperlinks, OCR (optical character recognition) technology was utilized to make specific word searches possible.

The entire project was completed in a four-month period and within budget. Since project completion, the NJ pharmaceutical has periodically requested File-X perform similar services on recently completed submissions and other day-to-day documents.



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