XML4Pharma

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XML4Pharma

Courses, Trainings, Presentations and Seminars

As an evangelist of the use of modern technologies in the pharmaceutical industry, XML4Pharma is providing a number of courses and trainings, presentations and seminars.

Courses/Trainings

LOINC and UCUM courses for healthcare and clinical research

More and more European countries are now mandating the use of LOINC and UCUM for Electronic Health Records (EHRs).
We are specialist in both LOINC and UCUM, member of the UCUM committee, and have developed lots of applications for the use of these standards, as well for healthcare as for clinical research.
Due to this obligation in many countries to implement LOINC and UCUM, we have developed several courses and trainings:

Introduction to LOINC: codes, short and long names, axes. LOINC answers and associated units, amd much much more (half day training)
Implementing UCUM: introduction to UCUM, automating unit conversions, annotations, ... half day training)
LOINC and UCUM: a combination of both these trainings (full day training)

How to comply with CDISC ODM, Define-XML and Lab standards (1 day)

We often get the question: "What should we do to comply to the CDISC technical set of standards ?"
Well, this course gives you the answers. It treats the ODM, Define-XML and Lab standards from the viewpoint of conformity. It learns you about those parts from the standard that are not covered by XML-Schema, about conformity levels, and how conformity can be reached by setting up the correct procedures in your organization and in cooperation with your business partners.
Topics covered are:

ODM, Define-XML and Lab: what are they meant for and how do they work ?
ODM, Define-XML and Lab: what is described in the standard but not covered by the XML-Schema ?
Conformity levels: what do they mean ?
Stepwise implementation of ODM, Define-XML and Lab standards
Tools to validate ODM, Define-XML files against the standard
Tools to validate Lab files against the standard: Lab ASCII implementation
Tools to validate Lab files against the standard: Lab XML implementation
Lab: Transmission agreements

This course is given by Jozef Aerts, who was one of the members of the CDISC Conformity Task Force.

How to comply with SDTM, SEND and ADaM submission standards (CDISC CORE) (half to 1 full day)

This training is regularly provided by us on behalf of CDISC. Please see the CDISC web site for more details.

Of course we do also provide CDISC CORE Implementation consultancy services.

Introduction to XML for working with the CDISC set of standars (1 day)

This basic XML course gives you a jump start in the use of XML for CDISC ODM and Lab.
We learn you everything you need to know about XML to be able to work with the CDISC set of standards: all the working examples are from the CDISC ODM and Lab (later also from the Protocol and define.xml standard).
Dependent on the kind of company and YOUR requirements, the following topics are treated:

XML and the ODM - introduction to XML: elements, attributes, namespaces, entities
The rules of the game: understanding XML-Schema (using CDISC Lab or ODM Schema)
Tools for working with XML: editors, viewers, checkers
XSLT: transforming XML documents to XML, HTML, PDF, SQL, ...
Quering XML documents: using XPath and XQuery
The structure of the define.xml (CRT-DDS) file, for submitting metadata to the FDA

CDISC-ODM and Lab Implementation (1 day)

This training is especially designed for Data Management companies, CROs, and Clinical Data departments at pharma companies. It learns you about the opportunities brought by the use of XML in the CDISC standards, and leans you how you can start implementing the CDISC set of standards without high costs.
Basic knowledge of XML is required.
Dependent on the kind of company and YOUR requirements, the following topics are treated:

Defining protocols and CRFs in the ODM (for sponsors)
Automated database construction from the MetaDataVersion section of the ODM (CROs and Data Management compnies)
Retrieving information from databases in the form of XML (How to ... )
Transforming database information into valid ODM-XML and Lab-XML using XSLT
Importing ODM or Lab data in a relational database and CDMS
Checking whether an ODM file is valid
Electronic Signatures in ODM 1.2 (XML-Signature) - how to do it
Automatic creation of eCRFs from the ODM
Native XML databases - what are they ?
Web Services for automated exchange of clinical data
The new mechanims for Vendor Extensions in ODM (1.2.1)

Web Services and APIs for Clinical Research Application Integration (half day or 1 day)

In the world of clinical research, the use of APIs and RESTful Web Services is rapidly growing. For example the CDISC-Library API is more and more used for application integration at CROs and sponsors, in order to improve efficiency enormously, often replacing the use of (hard to maintain) Excel worksheets.

Another example is the NLM Unit Conversion web service, enabling to almost fully automate the conversion between "SI units" and "US Conventional Units" for CDISC/SDTM submissions for different regulatory authorities, and the LOINC-SDTM Conversion RESTful Web Service" allowing to fully automatically populated the values for SDTM --TESTCD, --TEST, --SPEC, --LAT, --DIR, --EVLINT, --COLSRT, --RESTYP, --RESSCL when the LOINC code (obtained from the lab or the EHR) is known.

This course can now also be given at YOUR location, and adapted for YOUR specific needs !

Conditions are identical to those of our CDISC-ODM implementation course

These trainings are usually given on-site at your location, saving your coworkers traveling time and costs, and enabling us to customize the course to your special needs (when desired). Minimum group size is 5, maximum group size is 10.

These trainings can however also be provided online when necessary.

Languages: we can provide these trainings in English, German and Dutch, with the course materials in English

In our experience, it is extremely advantageous to combine this course with 1-3 days of consultancy, after which your company will be really ready for using the CDISC ODM or Lab in production.

The cost for each of these courses is € 2500 (SFr. 2400 / US$ 2850) for a group of 5-10 people (ex.VAT if applicable) for a full day, plus travel costs.
Please contact for prices for half day trainings

Course organisation Conditions

Note: We also provide trainings on behalf of CDISC. See the CDISC Education" web page for all details.

Program Course organisation Conditions

Presentations

We are known for our excellent presentations on the use of CDISC standards and related technologies at CDISC Interchanges and Phuse conferences.
If you want to have a repetition of one of these presentations, either online on on site for your company, please Send us an email. The advantage then is that we can easily extend, or even adapt the presentation to your needs, and allow much more time for discussions.
We can of course also develop a presentation tailored to your needs.