Paper CRFs were scanned by ISI on-site in the U.S. and the U.K. The Data Listing was provided to us in ASCII or RTF format. The Clinical and Summary Studies were provided in WordPerfect 5.2 format or paper.

To process the entire 187,000 pages, two people were assigned to spend approximately 4 months to compile the submission.

On September 25, 1997, after only 5 months of reviewing the Novartis file that ISI had processed, the FDA released a guidance document to the pharmaceutical industry establishing PDF as the standard for electronic submissions for Case Report Forms and Case Report Tabulations. This was the first such submission and the news of its success spread quickly within the FDA. A consumer safety officer from the FDA stated that the Novartis electronic submission was already considered a "gold standard" that other electronic submissions would need to follow.

This submission was honored by the Smithsonian Institution as part of the "1998 Innovation Collection" in Science.

At the time when we helped organize the Exelon submission, Image Solutions was described as "A small but reliable vendor, who could put in the extra effort at a reasonable cost, was hired to help create the electronic PDF…" While we maintain our attention to detail, reliability and cost effectiveness, we have grown to become experts in electronic submissions and are today one of the world's leading providers of electronic submission processing.