ISI’s services cover every aspect of paper and electronic document compilation, preparation, and assembly, with resulting guidance-compliant formats that include appropriate navigational aids and validation. ISI recognizes that your company may be better positioned to outsource submission processing than to immediately purchase all of the technology you would need to process the submission yourself. Whether you‘re doing your first submission or your 100th, we can help with:
- Submission processing of case report forms (CRFSource) and other regulatory documents (eSubSource), including:
- Scanning, clean-up, and web-hosting
- Submission assembly and content tracking in all the current submission types and structures
- Real-Time Repository Access, 24/7
- Support for agency demos and pilots
- Submission publishing (paper and electronic)
- Archiving
- Submission deliveries, through secure document transfer methods or in person
With ISI guiding you every step of the way, you can have complete confidence that your submission will be 100% compliant, on time, and delivered to any agency worldwide.