In March 2001, Image Solutions, Inc. (ISI) was approached by a rapidly growing pharmaceutical company based in Baltimore, Maryland to assist them in processing their first electronic NDA. With a very tight deadline, ISI delivered on-time having processed 42,440 pages, 47,602 bookmarks, and 4,022 hypertext links. Because of their expertise, ISI was also requested by the client to accompany them to the FDA when delivering the demo CD.
The client needed assistance on a supplemental NDA project with a very quick-turn around time. Initial timelines allowed for just 10 business days to complete the project from beginning to end. The project specifics detailed processing 2,175 pages of study reports, the datasets from 3 studies, 1,000 pages of patient profiles, 38,000 pages of CRFs, and miscellaneous documents. Most of the study reports were provided electronically with about 1,000 pages of appendices to be scanned. Datasets and patient profiles were all to be in a text based electronic format. The CRFs were to be provided as paper only.
Having no experience with electronic submissions, the company turned to ISI for our expertise. Our job was not only to provide a quality final product but also to educate the client on the process. Towards this end, we offered to do the final few days of processing on-site once the summary reports were available. This benefited the client in two ways. First, this expedited the review process. Second, it gave the client the opportunity to learn more about the electronic submission process. The ISI project manager and production team provided hands on instruction as they developed the electronic submission.
The project began with the receipt of the CRFs and patient profiles. The processing of the CRFs went quite smoothly. We were able to process 241 patients encompassing 34,477 pages and 43,266 bookmarks in a matter of days using CRFScan™.
The patient profiles were not as straight forward. In viewing the electronic files, we saw that margins were practically non-existent and the font very small. The client provided paper copies that while far from perfect, looked better than the electronic files. To ensure the highest quality possible, we quickly adapted our process. We scanned the pages and created manual bookmarks.
As this process finished, we received the core study report for item 8. This report was received as a mix of text-based and image-based PDF files. The volume turned out to be over 5,000 pages and due to FDA file size restrictions, needed to be split across 7 files. This file was processed in-house very efficiently using several of the tools from our ISIToolbox and eSub Suite plug-ins.
All of the above mentioned files were processed in about a week and then it was time to go on-site to help the client review what we had done so far, as well as to process the datasets and summary files for the report. We planned to be on-site for three days. Unfortunately, upon arriving on-site, unavoidable delays prevented the client from providing all of the files to us for processing. Instead, they asked us to process 2 image-based pdf files of background study reports while we waited.
After consulting with the client, we were able to identify the reason for part of the delay and assist our client by processing the source files for them. Inadvertently, the client had not embedded the fonts during the WORD to PDF conversion process which caused difficulty and delay.
The last of the documents were received just days before submission deadline. On our final day of processing, with the final CDs needing to go out by the end of the day via FedEx, the unthinkable happened…the complex our facility was in lost power. As we are committed to meeting every deadline, rather than gamble that the power would come back on, we assembled a mobile unit to go to a back up site (where power was available) to finish the project.
Not only was the client happy with the final deliverable, they also greatly appreciated our expertise and the our extraordinary efforts we took to ensure that we would meet their deadline. When it came time to go down to Rockville to give the FDA a demo which allowed the actual reviewers for the project an opportunity to be walked through the electronic submission, the client requested a project manager from ISI to join them.
In the end, ISI processed study reports for items 2, 3, and 8 (7,490 pages with 2,156 bookmarks and 4,022 hyperlinks); datasets for item 11, patient profiles for item 11 (240 patients, 473 pages, 2,180 bookmarks); CRFs (241 patients, 34,477 pages, and 43,266 bookmarks). We were able to accomplish this in a very short timeframe and met the needs of our client.