Case study · Mid-size US CRO · Oncology
Standardized Clinera EDC across 14 oncology studies
A US-based CRO running 14 active oncology studies was rebuilding the same eCRFs over and over. We replaced one-off builds with a reusable library and a validation pipeline — without disrupting in-flight studies.
The situation
Each study took 10–12 weeks to build. Edit checks and derivations were copy-pasted between studies with subtle drift. Post-FSFV defect rates were high enough that the DM team was firefighting instead of monitoring.
What we did
- • Audited the 14 study builds and identified 70+ shared form patterns (AE, SAE, ConMed, Vitals, Labs, ECG, PE, dosing).
- • Built a versioned eCRF library in Clinera with documented variants per therapeutic area.
- • Authored a peer-reviewed edit-check pack with date-window, range and cross-form logic — version-pinned per study.
- • Stood up a validation pipeline: requirements → tests → evidence → traceability, generated semi-automatically from study config.
- • Trained the CRO's internal DM and build team to extend the library themselves.
The result
40%
Faster study build
60%
Fewer post-FSFV defects
1
Unified Part 11 evidence pipeline
14
Studies on the shared library
New studies now go from protocol to UAT in 5–6 weeks. The DM team spends time on data quality instead of rebuilding forms. The CRO's QA lead reuses the same validation evidence pattern for every study, cutting audit prep from weeks to days.
What the client said
"We stopped reinventing the eCRF on every study. Elintex left us with a library our own team can maintain — and a validation pattern that actually holds up in audit."— Director of Clinical Data Management
Related: Clinera study build · Validation