Clinical & preclinical data management, answered

CDMP by NoyMed is a full-service clinical and preclinical data management provider. A single integrated team owns the entire data lifecycle — EDC and LIMS build and validation, continuous data cleaning, medical coding, safety reconciliation, CDISC SDTM/ADaM and SEND datasets, biostatistics and statistical programming, and database lock and closeout — under one contract. CDMP is a strategic spin-off of Streamlined Lean Solutions.

Clinical and preclinical EDC build (configuration, cross-instrument mapping, and full validation); continuous data cleaning (query resolution, automated validation checks, and ongoing safety reconciliation during conduct); medical coding with MedDRA and WHODrug; regulatory dataset mapping run in parallel with conduct (CDISC SDTM/ADaM for clinical, SEND for preclinical); biostatistics and statistical programming in SAS and R; and fast database lock with formal study closeout validation.

Software vendors sell database or platform access. CDMP provides complete operational execution — handling EDC licensing plus full data management, equipment data harmonization, CDISC/SEND mapping, and biostatistics under a single contract. We provide the people and the protocols to run the software.

An EDC system captures data electronically. A data manager defines the database architecture, establishes validation checks, flags data anomalies, reconciles safety metrics, and ensures the data complies with regulatory submission formats such as CDISC or SEND. The software is the bucket; data management is the governance that makes the data usable.

Emerging biopharma and biotech, mid-tier and niche CROs, preclinical testing facilities and sponsors, academic and investigator-sponsored research teams, and clinical trial sites supporting sponsor-assigned trials.

Yes. Mid-tier and niche CROs use CDMP for white-label, multi-platform clinical and preclinical EDC expertise and overflow data management and CDISC programming capacity, delivered under the partner's brand from our EU / Armenia delivery hub.

We build natively in TrialKit and configure and validate legacy and enterprise environments including Veeva Vault CDMS, Medidata Rave, Viedoc, Oracle Clinical / InForm, Castor, and Medrio. For preclinical work we operate in dedicated study management environments such as Instem Provantis. See Clinical EDC Solutions.

Yes. We provide end-to-end preclinical EDC and LIMS data management: environment setup and validation, laboratory instrument data integration, real-time validation checks, electronic audit trail management, and GLP compliance oversight, with output harmonized to SEND. See Preclinical EDC & LIMS Data.

SEND (Standard for Exchange of Nonclinical Data) is the CDISC standard for submitting preclinical safety and toxicology data to regulators such as the FDA. We map preclinical findings and trial-design information to SEND domains with controlled terminology, run conformance checking, and prepare define.xml and a reviewer's guide as part of a submission-ready package.

SDTM (Study Data Tabulation Model) standardizes collected clinical trial data; ADaM (Analysis Data Model) provides analysis-ready datasets traceable to SDTM. We program both in parallel with study conduct, validate them against published CDISC rules, and deliver define.xml and a reviewer's guide for regulatory filing. See Biometrics & Submissions.

We code adverse events, medical history, and concomitant medications using MedDRA and WHODrug, with clinician review of autocoder output and consistent coding conventions applied from first-patient-in through database lock.

Our biostatisticians and statistical programmers work in SAS and R, covering sample size and power support, statistical analysis plan input, interim and DSMB analyses, and production and QC of tables, listings, and figures.

Yes. We build custom API and file-based pipelines connecting central and specialty labs, toxicology equipment, eCOA/ePRO, wearables, imaging, IRT/RTSM, and specialty devices, with transfer specifications, automated reconciliation, and monitoring. See Multi-Source Integration.

Yes. We perform a rapid gap assessment, re-architect the build, migrate and reconcile historical data record-for-record, rebuild and re-validate edit checks and derivations with a fresh 21 CFR Part 11 / GCP validation package, and coordinate cutover — typically within 30 days. See Database Rescue & Migration.

Yes. CDMP operates on a 21 CFR Part 11, GCP, and GLP-validated foundation, with documented validation packages, controlled electronic signatures, and complete audit trails for both clinical and preclinical work.

CDMP maintains dual GDPR and HIPAA compliance across its delivery model, on a foundation validated to 21 CFR Part 11, GCP, and GLP. Contracting through the Netherlands headquarters supports lawful data handling for both EU and U.S. sponsors.

Contracting is executed via our Netherlands headquarters, ensuring full legal and regulatory alignment under both EU and U.S. law.

CDMP delivers from an EU / Armenia hub with extended U.S. time-zone overlap, and contracts through its Netherlands headquarters.

CDMP uses standardized, value-based rate cards that sit below traditional U.S. and Western European CRO benchmarks. Engagements are structured as predictable fixed-fee proposals, with volume discounts for high-volume or recurring study portfolios. Submitting basic study parameters produces a transparent quote in minutes, without a multi-week RFP cycle.

Clinical database or preclinical configuration go-live is typically achieved in 1 to 4 weeks depending on study complexity. Study rescue rebuilds and platform-to-platform migrations complete in 30 days or less.

Share your study type (clinical, preclinical, or both), study phase or stage, preferred platform or EDC environment, site or laboratory and subject scope, and target timeline. We return a transparent, fixed-fee proposal without lengthy intake cycles. Request a proposal.