Regulatory Submission Outsourcing
Case Studies
Client Engagement:
Legacy Document Conversion
Octagon Regulatory Operations staff inventoried and scanned over 800 boxes of clinical documentation that was being evaluated for an upcoming regulatory submission. Documents were shipped to the Octagon facility where immediate indexing and processing occurred. This task took approximately 2.5 months. The tight timeline was met because the team had documented processes in place to ensure quality deliverables. Scanning was then completed over the course of 6-8 months and was conducted efficiently as the inventory helped locate the documents that needed to be scanned. As documented were converted to PDF (Portable Document Format), the team also added navigation (bookmarking and hyperlinking) to those documents identified for submission. M5 (Clinical) include 1,300 Case Report Forms which were scanned from the boxes. The entire submission was completed in approximately 14 months after the box inventorying was started and included:
- Size: 39.1 Gb
- eCTD Leafs: 10,110
- Folders: 1,343
- PDF Files: 7,763
- Pages: 1,293,973
- Hyperlinks: 710,621
- Bookmarks: 424,582
Client Engagement:
Legacy Document Conversion
Octagon's Regulatory Operations team was deployed to a client's European site to develop and execute an archiving strategy. This included scanning and reviewing legacy documents. The site was in the process of closing so the Octagon team worked with the client to develop a comprehensive archiving strategy and to complete the legacy document scanning of 362,028 pages. As the client's staff was being redeployed and let go, there was a tight timeline. Scanning was completed during two, two week trips. With Octagon's mobile capabilities, including scanning stations and trained resources, the team was able to inventory the paper documentation, scan and convert the materials to an electronic format and quality control all documentation prior to the critical deadline. This effort included scanning 362,028 pages within 4 weeks (approximately 13,000 pages per day).
Client Engagement:
Content Planning
One of Octagon's strong differentiators in the submission management arena is our internal knowledge and understanding of the importance of content plans for proposed submissions. We believe a good content plan is essential to the success of a submission project. Octagon's Regulatory team counseled an emerging biopharmaceutical company in the development and management of their submission content plan. Because the organization was new to eCTD submission format, they leveraged Octagon's extensive experience to help guide their project team through the critical planning phase. Octagon assisted the client in determining what documents were required, what documents currently existed and where documents should be located within the eCTD submission structure. As a result of the thorough planning, the team was able to successfully manage all of the components of the submission and meet their target deadline.
