FDA Electronic Submission Gateway: Return on Investment
Business Case
In 2005, Company G made approximately 1500 electronic submissions that would have fit the ESG scope if it had been available. The following table compares the costs of sending 1500 submissions manually with sending 1500 submissions through the ESG. Note that the ESG carries a startup cost of approximately $40,000 (for training, security certificates, and hardware), but even with this included, it is far more cost-effective to send submissions electronically.
Table 1
Comparative Cost Projections Based on 1500 Submissions
(traditional media submissions vs. electronic submissions) |
| | Operating Costs,
Traditional Media | Operating Costs, ESG |
| Unit Cost ($) | Quantity | Total Cost ($) | Unit Cost ($) | Quantity | Total Cost ($) |
Shipping | 8.25 | 1500 | 12,375 | N/A |
| Credentials (digital certificates) | N/A | 20 | 20 | 400 |
| Resources: | |
| Hours | 63.89 | 1500 | 95,835 | 63.89 | 104 | 6644 |
| Quarter Hours | N/A | 15.97 | 1500 | 23,955 |
| Materials: | |
| CDROM | 0.15 | 1490 | 223 | N/A |
| DLT | 50.00 | 10 | 500 | N/A |
| Binders (Cover Letters) | 1.50 | 1500 | 2,250 | N/A |
| Total Cost |
$111,183.00 |
$30,999.00 |
Below are a few of the benefits realized following the implementation of the FDA ESG in 2006 for Regulatory (non-AERS) submissions:
- Improves costs, resource requirements, and time efficiencies for both Sponsors and the Agency
- Facilitated moving product teams to a fully electronic submission process
- Obviated need to burn CDs/DVDs or create tapes
- Reduced hardware/software, costs, and resources associated with media creation
- Eliminated QC of submission associated with creating media
- Eliminated courier and FedEx fees associated with Regulatory submissions
- Eliminated paper output
- Reduced costs associated to processing, tracking, and archiving paper
- Reduced costs associated with maintenance of 3 DocuTech printers
- Eliminated need for DocuTech printers (within 1st year of implementation)
- Facilitated redeployment and reduction of resources required to process paper or media-based submissions
- Provided a more efficient and secure transfer of electronic submissions
- Enabled implementation of SAFE Digital Signatures which facilitated additional benefits/gains
- Facilitates earlier receipt of the submission by the Agency and access to the submission by the Reviewer
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