Clinical Data Standards
CDISC SDTM
Study Data Tabulation Model for clinical trial submissions. Export preclinical and clinical data in FDA-accepted format for regulatory filings.
CDISC ADaM
Analysis Data Model for statistical analysis datasets. Structure analysis-ready data with proper metadata and traceability to source.
CDISC SEND
Standard for Exchange of Nonclinical Data. Export in vitro and preclinical study results in the format required for IND submissions.
ODM-XML
Operational Data Model for clinical data interchange. Import/export study definitions, clinical data, and metadata in a vendor-neutral format.
Health Information Exchange
HL7 FHIR
Fast Healthcare Interoperability Resources for real-world data integration. Connect to EHR systems for patient data and treatment outcomes.
HL7 v2
Legacy healthcare messaging for laboratory information systems. ADT, ORU, and ORM message types for LIMS integration.
CDA
Clinical Document Architecture for structured clinical documents. Generate and parse C-CDA documents for continuity of care.
IHE Profiles
Integrating the Healthcare Enterprise profiles for clinical workflow integration. XDS, PIX, PDQ for document sharing and patient identity.
Compliance Standards
ICH E6(R2) GCP
Good Clinical Practice guidelines compliance for clinical trial data integrity, audit trails, and electronic signatures.
21 CFR Part 11
FDA regulations for electronic records and signatures. Full audit trail, access controls, and validation documentation.
EU Annex 11
EMA computerized systems regulations for GxP environments. Risk-based validation and data integrity controls.
HIPAA
Health Insurance Portability and Accountability Act compliance for protected health information handling.
GDPR
General Data Protection Regulation compliance for EU data subjects. Data minimization, consent management, and right to erasure.