Problem
A biotech startup was preparing its first FDA submission. Their clinical trial data was scattered across six different systems — lab instruments, spreadsheets, third-party services, and manual trackers. Pulling it all together for a submission required three people working for three weeks, copying data between systems and checking everything by hand.
Every manual step introduced the risk of errors. A practice run found 47 data mismatches that had to be tracked down one by one. Worse, there was no record of how the data had been transformed along the way — a problem when regulators ask “show us exactly how you got these numbers.”
With a regulatory deadline approaching, they needed a system that was faster, more reliable, and defensible under FDA review.
Approach
We built an automated system that pulls data from all six sources, applies validated processing rules, and produces submission-ready files with a complete record of every step.
- Data connections: We built connectors for each system — lab instruments, spreadsheet files, and third-party services. Everything flows into a single standardized format with a clear record of where each data point came from.
- Automated processing: Transformation rules are defined once and applied consistently every time. Every step is logged — what went in, what came out, which rule was applied, and when.
- Compliance built-in: Electronic signatures on approved datasets. Complete audit trail meeting FDA requirements. Clear separation between who prepares data and who approves it.
- Automatic error checking: Cross-checks between data sources, range validation, and format compliance checks run automatically. Problems are flagged immediately with a clear explanation of what’s wrong and where it came from.
Results
The first full run processed 18 months of clinical data in 4 days, down from 3 weeks by hand. The automatic checks caught 12 data issues, each with a clear source so the team could fix them immediately. The regulatory team described the resulting submission package as “the cleanest data trail we’ve ever submitted.”
The system now runs continuously as new trial data arrives, so submission prep is no longer a scramble — it’s a byproduct of day-to-day operations.