Clinical Data Management

Clinical data management turns protocol-defined data into clean, lockable datasets. Viltis supports CDM activities from CRF and eCRF design through database build, edit check specification, query management, medical coding, and soft or hard lock. Work is grounded in the protocol and SAP so the database collects what analysis and CSR writing will actually need, nothing more that only adds site burden. Annotated CRFs and data specifications are kept current when amendments change visits or endpoints. That discipline keeps programmers and medical writers from discovering missing fields after lock.

We help teams write or review data management plans, annotate CRFs, and define discrepancy management rules that are specific enough for CRAs and sites to act on. EDC build validation, user acceptance testing, and go-live readiness are treated as quality-controlled steps. During study conduct, we watch query aging, missing pages, and protocol deviation data that may signal operational issues outside CDM alone. External data from labs, imaging, or ePRO vendors is scheduled and reconciled on a defined calendar, not absorbed as one-off file drops.

As lock approaches, focus shifts to SAE reconciliation with pharmacovigilance, coding consistency, third-party data completeness, and freeze criteria that sponsors can defend. We can lead DM for a study, augment an existing DM team, or provide independent review of vendor DM deliverables before you accept them. Soft lock is used as a real control point with documented open issues, not a date on a slide.

Good CDM also protects sites from unnecessary complexity. Edit checks are tuned to catch true errors without flooding sites with low-value queries. That balance improves data quality and keeps CRA time on monitoring risk instead of babysitting the EDC.

Clinical data management support commonly includes

• eCRF design and annotated CRF review
• Edit check and discrepancy management specs
• EDC UAT and go-live readiness
• Query metrics and site data cleaning support
• Medical coding oversight for AE and concomitant meds
• SAE reconciliation with safety systems
• Database soft lock and hard lock readiness

If your study data are noisy, late, or poorly specified relative to the analysis plan, we help reset CDM practices so lock is a controlled event rather than a negotiation with unresolved queries.