Non-clinical data, captured cleanly and ready for SEND

What we do

Preclinical facilities moving off paper — or scaling up electronic capture — often have the science and the instruments but not the in-house data management expertise to configure the platform and map findings to FDA-mandated formats. CDMP fills that gap. We set up protocol-driven study parameters, build real-time validation checks for instrument data capture, and manage the electronic audit trails that keep a study inspection-ready.

We work in dedicated preclinical study management environments such as Instem Provantis, and integrate the analytical and in-life instruments around them. The output is structured, validated data that maps directly to SEND without a late-stage scramble.

What's included

• Environment setup & validation: protocol-driven study configuration in Provantis or your preclinical LIMS/EDC, with documented validation.
• Instrument data integration: automated capture from balances, clinical pathology analysers, and in-life data collection systems.
• Real-time validation checks: range, plausibility, and protocol-conformance checks at the point of capture.
• Electronic audit trail management: complete, reviewable change history aligned to GLP expectations.
• GLP compliance oversight: data-integrity controls (ALCOA+), access management, and study-file readiness.
• SEND mapping: findings harmonized to SEND domains and controlled terminology — see Biometrics & Submissions.

Built for GLP data integrity

CDMP operates on a 21 CFR Part 11, GCP, and GLP-validated foundation. For preclinical work that means enforced attributable, legible, contemporaneous, original, and accurate records, controlled electronic signatures, and an audit trail a monitor or inspector can follow end to end.