CRONCOX's flagship discipline. From CRF design through database lock, we build study databases that are CDISC-native, audit-ready, and engineered to remove the bottlenecks that delay clinical programs.
From the moment your protocol arrives, CRONCOX takes ownership of every stage of data management — proactively, transparently, auditably.
Protocol-aligned, CDASH-compliant CRF design. Annotated CRFs, completion guidelines, and edit specifications delivered to sponsor standard.
Study database build in Medidata Rave, Oracle InForm, Veeva Vault EDC, OpenClinica, and REDCap — with full system validation.
Range, logic, cross-form, and dynamic edit checks. UAT-validated and signed off before go-live. Continuous tuning during conduct.
Study-specific DMP authored to ICH-GCP standards. Defines data flow, query conventions, coding, lock criteria, and quality metrics.
Proactive query generation, tracking, and resolution. 24-hour turnaround SLA. Site-level dashboards for transparency.
MedDRA (latest version) for AEs and medical history. WHODrug for concomitant medications. Coding conventions document maintained.
Continuous reconciliation between EDC and safety database (Argus / ArisGlobal). Discrepancy resolution before lock.
Pre-lock review, freeze, soft lock, hard lock. Lock checklist validated by independent QA. Documentation for inspection readiness.
SDTM v1.8+ mapping, ADaM v1.3 analysis datasets, define.xml, reviewer's guide, and full submission package.
CRONCOX is platform-agnostic. We're certified across the major EDC and biometric platforms, so sponsors don't have to migrate to work with us.
Protocol review, DMP authoring, CRF design, edit check specification, and standards alignment.
EDC database build, edit check programming, UAT execution, and validation documentation.
Data entry support, query management, coding, SAE reconciliation, and continuous data review.
Pre-lock review, database freeze/lock, SDTM/ADaM generation, and transfer to sponsor.
Our quality management system aligns with ICH-GCP E6 (R3), 21 CFR Part 11, EU Annex 11, GDPR, and CDISC. Audit trails are continuous. SOPs are practised, not just printed.