Clinical Data Cleanerv1.0.0

A mid-sized CRO needs to validate SDTM datasets for a Phase III trial before FDA submission. The skill automates domain checks for DM, LB, and VS, flagging missing required fields and out-of-range lab values, ensuring regulatory compliance.

A biotech startup has raw case report form (CRF) data from a Phase I study and needs to convert it to CDISC standard for submission. The skill cleans, maps variables, and produces SDTM-ready datasets with audit trails.

A hospital research team analyzes lab data from a clinical trial and needs to flag extreme values (e.g., glucose > 500 mg/dL) that may indicate errors or adverse events. The skill uses clinical thresholds and IQR to detect and optionally cap or remove outliers.

An academic research group handling a longitudinal study faces missing vital signs data. The skill applies median imputation (or forward-fill) to fill gaps while documenting the method for audit readiness.

A global pharma company collects visit dates from multiple sites in various formats. The skill standardizes all dates to ISO 8601 (YYYY-MM-DDTHH:MM:SS) for consistent analysis and submission.

Offer the skill as a cloud service where CROs pay a monthly fee per trial or per dataset. Revenue is generated from recurring subscriptions and tiered pricing (e.g., basic vs. advanced compliance features).

License the skill to pharma companies as part of a data management consulting package. Revenue includes upfront license fees plus per-project consulting charges for setup and validation.

Release the core skill as open source (MIT) to drive adoption, then sell enterprise support, custom domain add-ons, and audit-ready reporting services. Revenue from annual support contracts.