Study reports assembled from your data, ready for the study director
The bench work finishes and the report becomes the bottleneck. Methods come from the protocol and its amendments and tables come from the analysis exports, and every number has to match the raw data before QA sees it. The agent does the assembly and the cross-checking. The study director keeps the interpretation and the signature.
Examples use invented names and figures.
What the agent does
- Step 1Collects the inputs
The signed protocol or study plan, its amendments, the deviation log and the approved data exports from your LIMS or analysis software. It works from copies and never edits a source record.
- Step 2Drafts the report sections
Methods, results tables, figure legends and a deviations section, each drafted from its source document and laid out in your report template.
- Step 3Checks every value
Each number in the text and tables is traced back to its source export. Mismatches in values, group sizes, units or rounding go on a flag list with the source value beside them.
- Step 4Hands the draft over
The study director receives the draft with its checking record, which shows what the agent wrote and where each value came from. Review and signature happen in your own systems.
Interpretation and conclusions belong to the study director, who under GLP is the single point of study control. Contributing scientist reports, the QC sign-off, QA's independent audit and every signature stay with people. In GLP work the agent copies reportable values from your validated systems and checks them. It calculates them only where that step has been validated under your quality system.
- Study director hours per report
- Days from data lock to draft report
- QC findings per report
- Sponsor comment rounds per report
Questions about this agent
Can it work on GLP studies?
Yes, as a drafting and checking step. The study director reviews and signs, QA audits independently, and the final report lives in your validated system. Exploratory pharmacology and DMPK studies usually sit outside 21 CFR Part 58, which makes their reports a good first workflow. Confirm applicability from each study's purpose and intended regulatory use, and move to GLP reports after the required validation and quality-system approvals. Our page on GxP validation for AI workflows covers what that involves.
Which systems can it read from?
Approved exports and reports from study management systems such as Provantis or Pristima, a bioanalytical LIMS such as Watson, analysis tools such as Phoenix WinNonlin or GraphPad Prism, and Excel. We agree exports or read-only access during scoping, so the agent never writes into a system of record.
Will sponsors accept reports drafted this way?
The report the sponsor receives is your report, reviewed and signed by your study director. Check the sponsor agreement for any restrictions on AI use. Keep a log of which sections the agent drafted and who reviewed them, so you can answer a sponsor with evidence.