Source Integrations

Clinical systems we cover

• EDC: Rave, Medidata, Veeva EDC, Castor, OpenClinica, REDCap, and custom EDC APIs.
• CTMS: Veeva CTMS, Medidata, Oracle Siebel/Argus integrations, and sponsor-built CTMS.
• eCOA / ePRO: Medable, IQVIA, YPrime, and other vendor APIs.
• Labs / Central Labs: Vendor SFTP/API feeds, LOINC mapping, and near–real time updates.
• Safety / PV: Argus, ArisGlobal, and case exchange standards.

API-first and automated

• Event-driven loads with incremental sync, webhooks, and secure secrets management.
• Schema drift detection, backward-compatible change handling, and retry-safe orchestration.
• Staging → conformance → curated layers with validation and quality thresholds.
• Data contracts to keep vendors aligned on payloads and SLAs.

Governed by design

• PII/PHI controls with tokenization or hashing in your environment.
• End-to-end lineage and audit trails for inspection readiness.
• Role-based access control, row/column-level security, and data minimization.
• 21 CFR Part 11–ready processes and validation pack where required.

Clinical semantics

• Harmonization to sponsor-defined models and mappings to standards (CDISC SDTM/ADaM-ready where applicable).
• Terminology services: MedDRA, WHODrug, LOINC alignment and versioning.
• Derived feature layers for analytics, risk signals, and AI readiness.

Onboarding

We start with a blueprint of priority sources and study timelines. We define APIs, credentials, and delivery cadence, then configure mappings and validation rules.

Operations

24×7 monitored pipelines with alerting, SLAs, and issue triage. Proactive schema change capture avoids breaking changes in downstream analytics.

Outcomes

Reliable, governed data products consumed by BI/ML and downstream apps. Faster study insights, fewer manual reconciliations, and a foundation for AI use cases.