K3 data management covers the full study lifecycle: CRF design and EDC build, edit-check specification and testing, ongoing cleaning and query management, medical coding, external data reconciliation, and lock. We surface data issues while they're still cheap to fix — not in the week before lock.
Our data managers work hand-in-glove with K3 biostatistics, which means the datasets that leave data management arrive at programming in the shape programming expects. One team, no handoff loss.
What we deliver
- CRF / eCRF design & EDC build — any major EDC platform, tested edit checks
- Data cleaning & query management — continuous, metric-driven, transparent
- Medical coding — MedDRA and WHODrug, with versioning discipline
- External & vendor data reconciliation — labs, ECG, IRT, ePRO
- SAE reconciliation — aligned with pharmacovigilance on a fixed cadence
- Database lock — documented, auditable, on the date we agreed
How we engage
FSP — a standing biometrics function with governance, SLAs, and capacity planning. Project-based — this scope, one accountable lead, priced to the outcome. Resourcing — senior specialists embedded in your team, compliance-current from day one.
Works with
Optional acceleration
Pair data management with SPARC to generate CDISC-ready exports and automated conformance checks as the study runs — so lock-to-submission time shrinks from months to days.
Our technology portfolio →Classic delivery is the default on every engagement. Platform acceleration is a choice you make — never a condition of working with K3.
At a glance
- Team: senior-level, 92% retention
- Compliance: current, all 50 states
- Systems: designed & validated for 21 CFR Part 11
- Engagement: FSP · project · resourcing
Put a senior biometrics team on it.
Send the protocol, the RFP, or just the problem. Named people and a scoped approach in return.
Contact K3