from first capture to final decision
Unified, inspection-ready data
Kernel builds a modern data foundation for research and clinical trials. We’re vendor-agnostic and standards-first, delivering reliable, analysis-ready, submission-ready datasets at program scale.
Standards-first governance
We design every study on Clinical Data Interchange Standards Consortium models—Study Data Tabulation Model (SDTM) for collection/structure and Analysis Data Model (ADaM) for traceable outputs—then annotate eCRFs to database variables, origins, and coding. CDASH, MedDRA, WHO-DD, LOINC, and other controlled terminologies keep data harmonized for 21 CFR Part 11 and ICH E6(R2) expectations.
Core technological platforms
Converged capture, minimal site burden
We combine electronic source (eSource) and electronic data capture (EDC) with patient-reported outcomes (eCOA), wearables/IoT signals, and digital therapeutics (DTx) usage/adherence data, enriching endpoints without extra workload.
Surrounding systems like randomization and trial supply management (RTSM/IRT), central labs, imaging, and safety flow through governed integrations. Where policy allows, real-world data (RWD) from electronic medical records (EMR) and de-identified activity datasets complement feasibility and endpoint corroboration. Exports are PDF/CSV/Excel for human-readable and machine-ready use.
Risk-based oversight, end-to-end visibility
We embed risk-based quality management (RBQM) with centralized monitoring, key risk indicators, and exception workflows. Tight links to your clinical trial management system (CTMS) and electronic trial master file (eTMF) keep documents, data issues, and milestones synchronized with complete audit trails and fewer surprises.
Always analysis-ready
Builds include CRF header/navigation standards (protocol/site/subject/visit), visit windows, field-level validations, unit controls, and tooltips. Automated ETL/ELT pipelines reconcile external vendors, map legacy data to CDISC SDTM/ADaM, and keep datasets clean daily—not just pre-lock.
Privacy by design
We operate under ICH E6 Good Clinical Practice (GCP) with HIPAA & GDPR aligned workflows, role-based access control (RBAC), encryption, lineage, and full auditability. Connected eTMF/CTMS, RBQM, and CDISC standards protect patients, preserve integrity, and satisfy regulators.
Continuity, Backup & Archival
We run mirrored/failover infrastructure with scheduled disaster-recovery tests, plus daily incremental and weekly full encrypted backups to off-site/cloud storage. At study close, we create a read-only final database with complete audit trails, retain it (typically 15 years), and routinely test restores to verify data integrit