Life sciences · CRO & clinical research Delivered in 8 to 12 weeks
From study data to the sponsor report, without re-keying
In a clinical research CRO, data from the investigator sites arrives in the electronic data capture system (EDC), is reworked in Excel for tracking tables, then converted to CDISC by hand. Every sponsor report takes several days, and sponsors write in to ask where their study stands.
The problem
Data scattered across the EDC, the clinical trial management system (CTMS), Excel and e-mails, manual rework that is hard to reproduce, traceability required by audits (GCP, 21 CFR Part 11) and sponsor reports that take several days.
Our solution
- 01 Connect the EDC, the CTMS and working files to a traced data space, without re-keying.
- 02 Replace Excel rework with automated, versioned analyses and CDISC exports.
- 03 AI agents that prepare sponsor reports from validated data, reviewed by the team, and a space where sponsors follow their study’s progress.
Expected outcome
- Sponsor reports in hours
- Data ready for audits
- Sponsors informed in real time
- More studies without more hires
Illustrative story, inspired by situations we have met in the field. Discuss a similar case