Data Infrastructure for Clinical Trials
A governed, vendor neutral data management platform in your environment that unifies clinical data across all vendors and studies - enabling analytics, AI, and safe writeback to operational systems.
Unify Sources
Bring EDC, CTMS, eCOA/ePRO, Labs, Safety (PV), IRT, and Quality data together in one governed platform. Stop exporting and start analyzing across vendors and studies.
Govern & Control
Establish lineage, roles, masking, and change control aligned to GxP/GCP. Your metrics are trusted, consistent, and audit‑ready.
Deliver Outcomes
Turn governed data into action with analytics and decision support, AI readiness, and write‑back. Close the loop across central monitoring, RBQM, safety, and portfolio decisions.
Bridge clinical trial data silos with a unified platform
- Per‑study EDC builds by different CROs/vendors (Medidata, Veeva, Oracle, etc.)
- Vendor tools visualize only a single study-limited customization and high cost
- Manual exports/reconciliations and inconsistent designs delay cross-study insight
- Continuous ingestion into Snowflake or Databricks for all vendors and studies
- Medallion layers: Bronze (raw) → Silver (standardized) → Gold (analytics‑ready)
- Standards mapping (e.g., CDISC) with lineage, roles, masking and audit trails
What we deliver
- Continuous ingestion from all vendors and studies
- Harmonized, standards‑aware models with lineage
- Vendor‑neutral integration patterns
- Harmonized data products for consistent metrics
- Performance‑tuned models for fast, reliable dashboards
- Tool‑agnostic: Power BI, Tableau, Spotfire, SAS
- GxP/GCP validation support and documentation
- Masking, approvals, audit trails
- Delivered in your tenant, you own it
- Robust metadata and lineage
- Data contracts and evaluation workflows
- PHI/PII controls and governance
- Safe LLM adoption on governed data
- Closed‑loop updates to EDC/CTMS with maker‑checker controls
- Audit trails and rollback strategies
- Reduce cycle times and improve quality
Deliverables and documentation to support audits and inspections.
Catalog/lineage, roles, masking, and controls aligned to least privilege.
Workspaces, deployment, change control and release management.
Delivered in your environment, your data stays under your control.