XML4Pharma Services
XML4Pharma provides the following services
Consultancy:
- Consultancy in the area of CDISC Standards,
especially CDISC ODM,
Define-XML,
SDTM and
SEND,
Dataset-JSON,
the modern submission format, and CDISC CORE, which is expected to replace Pinnacle21 soon as the validation tool used by the regulatory authorities such as the FDA, PMDA, and NMPA.
- NEW: CDISC-CORE consultancy: implementation and integration, development of "custom" (organization-specific) CORE rules
- CDISC Implementation services
- CDISC Library API Implementation
- CDISC Transformation Services
- Consultancy in the area of XML and JSON technologies - education/training, selection, implementation
- EHR-CDISC Integration
- Development of tailored software for working with CDISC standards
Software and Consultancy for working with the CDISC Library API
The CDISC Library API (formely SHARE-API) has now been made available to all CDISC members.
This API is meant to be used using RESTful Web Services, which is the most modern way of machine-machine communication.
XML4Pharma has made some contributions to the development of this API, including making "how to" examples available (link requires a CDISC login),
and has itself also made free RESTful Web services
available for working with CDISC standards (which in some cases go considerably beyond what the CDISC Library offers).
As a recognized specialist in RESTful Web Services and in CDISC standards, we are now offering consultancy and software development services for working with the CDISC Library API.
So, if your company would like to use the CDISC Library API, but does not have the necessary resources or knowledge to do so, we will be happy to help you.
Software development:
- Core technologies: Java, XML, JSON, XML-Schema, XSLT, XPath, XQuery (and other XML related technologies)
- Development of software and systems for working with the CDISC set of standards, especially ODM. SDTM/SEND and Lab standards
- XSLT stylesheet development for transformation of XML documents into HTML,
PDF (our specialty) and XML to XML transformation
- Technical support of Java-based open-source clinical data management systems
- Tailored software development
- Translation of legacy software to modern computer languages (Java, Python)
- Development of software for working with the CDISC set of standards
- Tailored RESTful Web Services software development(clinical data exchange, BioInformatics, ...)
Examples of important systems that we developed
- The CDISC ODM Checker (freely available for CDISC members)
- The SDTM-ETL software for designing and executing mappings between ODM and SDTM
- The CDISC ODM Generator for converting character-delimited "flat text" files, SAS Tranport 5 and sas7bdat files into CDISC ODM, including merging them into a single ODM file (e.g. for archival).
- Many other products for working with the CDISC set of standards
- Web Services demo/prototype for clinical data exchange
- Software for retrieval of clinical data from a CDMS (relational database) or EDC system and transformation to ODM format (several companies)
- Web-enabling and RESTful Web Services enabling of legacy software
XML4Pharma, Griesegg 39, 6464 Tarrenz, Austria
