Data Management Platform
A vendor‑neutral platform delivered in your environment (Snowflake or Databricks) that unifies data across clinical, safety, regulatory, and quality. It provides MDM, governance, AI readiness, and cross‑functional integration as a single, reliable foundation for analytics and oversight.
Unified data layer
- Continuous ingestion from EDC, CTMS, eCOA/ePRO, Labs, Safety, IRT, and Quality systems
- Medallion architecture (staging → conformance → curated) with lineage
- Standards‑aware mappings and harmonization to sponsor models
Governance & MDM
- Enterprise catalog, end‑to‑end lineage, and controlled vocabularies
- Master data for studies, sites, products, code lists, and investigators
- Quality rules, release management, and approvals
AI readiness
- Data contracts and evaluation workflows for safe LLM adoption
- PII/PHI controls with masking or tokenization and access policies
- Prompt/response evaluation, guardrails, and monitoring
Cross‑functional integration
- Link safety cases to study data, manufacturing lots, and quality signals
- Harmonized identifiers across studies, sites, investigators, and products
- Lifecycle views spanning development to post‑market quality
Blueprint
Jointly define scope, data sources, and controls. Establish mappings, validation rules, and SLAs.
Build & validate
Configure pipelines, harmonization, and governance. Provide validation pack material where required.
Operate
Monitored operations with alerting, change management, and proactive schema drift handling.
Build a governed foundation for clinical and safety data
Delivered in your environment, no vendor lock‑in.