XML4Pharma is a CDISC Registered Solutions Provider specializing in XML technologies for pharmaceutical research. The company develops software and provides services for implementing CDISC standards, including SDTM ETL and define.xml creation. They support pharma companies, CROs, and academic institutions with data standards implementation and integration using Web Services and native XML databases.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical sponsors, CROs, and research institutes must adopt CDISC standards (ODM, SDTM, Define‑XML, Lab) for clinical data exchange and regulatory submissions, but implementing, validating, and maintaining these XML‑based specifications is complex, time‑consuming, and prone to errors when done manually.
Solution
XML4Pharma delivers a suite of CDISC‑focused software tools and professional services that automate the creation, transformation, validation, and exchange of CDISC XML documents. The platform leverages native XML databases, XSLT/XPath processing, and SOAP/REST web services to map ODM metadata to SDTM datasets, generate Define‑XML specifications, and convert Lab ASCII files to XML. Integrated validation engines (ODM Checker, Define‑XML Checker, Lab Checker) ensure conformance to CDISC rules, while eCRF generation and electronic signature modules streamline data capture and regulatory compliance. Consulting, training, and custom development services help organizations adopt the standards efficiently and integrate them into existing clinical data management workflows.
Target Audience
Primary customers are pharmaceutical sponsors, contract research organizations, data‑management companies, and clinical technology vendors that need to create, exchange, or validate CDISC‑compliant clinical data.
Features
- SDTM‑ETL: visual mapping engine that transforms ODM metadata into SDTM/ADaM datasets and produces accompanying Define‑XML files.
- ODM Study & Define‑XML Designer: unified GUI for designing clinical studies in ODM and authoring Define‑XML without manual XML editing.
- CDISC ODM Checker and Define‑XML Checker: schema‑ and Schematron‑based validators that detect both structural and semantic violations, reducing false‑positive errors.
- Lab ASCII‑to‑XML Converter and CDISC Lab Checker: automated conversion and validation of laboratory data in both ASCII and XML formats.
- Native XML database demo with XPath query support for rapid retrieval of eCRFs and metadata.
- SOAP and RESTful web services (including CDISC Library API integration) for programmatic exchange of ODM files between sponsors, CROs, and EDC systems.
- Automatic PDF report generation from ODM documents and eCRF creation via XForms, enabling end‑to‑end electronic data capture.
- Electronic signature module supporting XML‑Signature standards for 21 CFR 11 compliance.
- Tailored consulting, custom software development, and accredited training courses on CDISC implementation and XML technologies.