XML4Pharma Newsletters
Nr.47: December 2014
Content:
- Serious discounts on software products
- FDA publishes SDTM and SEND rules
- Free web services for use in clinical research
- SDTM-ETLTM 3.1 released
- Source code of "Smart Dataset-XML Viewer" software now freely available
- The XML4Pharma demo application server up and running again!
Nr.46: November 2013
Content:
- FDA accepts define.xml 2.0
- Moving from define.xml 1.0 to define.xml 2.0
- SDTM-ETLTM 3.0 in development
- The new SDS-XML standard
- Tools for working with the new SDS-XML standard
- The "Smart SDS-XML Viewer"
Nr.45: February 2013
Content:
- SDTM-ETLTM 2.2 is released
- CDISC EU Interchange Bad Nauheim/Frankfurt
- Preparing for define.xml 2.0
- Blogging
- SDTM-ETLTM: suggesting the ideal length for an SDTM variable
Nr.44: October 2012
Content:
- Editorial
- CDISC publishes draft of v.2.0 of the define.xml standard
- FDA starts thinking about SDTM, ADaM and SEND submissions in XML
- CDISC Interchange Baltimore
- XML-Schema 1.1 is W3C recommendation
- HL7 certification received
- Some of our students projects
Nr.43: January-February 2012
Content:
- SDTM-ETLTM v.2.0 is out!
- CDISC Journal: our article
- Two new blogs
- HL7 training course
- Wayne Kubick is the new CDISC CTO
- A student's project: automated generation of SDTM databases for FDA-CDER
- CDISC publishes draft standard for SDTM Device Domains
- Cool Technology: XForms on the tablet
- CDISC European Interchange Stockholm
Nr.42: October 2011
Content:
- Professorship at the Joanneum University Graz
- The future of XML4Pharma
- CDISC publishes the "Study Design Model in XML" (SDM-XML) final
- SDTM-ETL v.1.4
- Gartner analyst discusses HL7-v3 messages
Nr.41: June 2011
Content:
- ODM-SDM (Study Design Model) extension to be published for public review in the next days
- ODM Study Designer ready for ODM-SDM
- XML4Pharma's SMART Challenge submission is now life
- CDER amendments of SDTM-IG 3.1.2
- New features in the upcoming release of SDTM-ETLTM
- CDISC Express - the next "silver bullet"?
- CDISC publishes new Controlled Terminology - also in ODM format
- Cool Technology
Nr.40: April 2011
Content:
- Join us at the European CDISC Interchange in Brussels
- XML4Pharma takes part in the SMART Challenge
- Electronic Health Reords exchange: messages or services?
- Heavy discussions again about the value of HL7-v3 and the RIM
- Status of the ODM-SDM extension
- Over 250 entries from XML4Pharma on the CDISC Public Discussion Forum
- More educational movies on SDTM-ETL
- Cool technology
Nr.39: February-March 2011
Content:
- Successful CDISC German-speaking User Group Meeting
- SDTM-ETLTM movies on the web
- XML4Pharma to present about "define.xml good practices" at the European CDISC Interchange
- Cool Technology: KNIME
- New versions of the ODMChecker available
Nr.38: January 2011
Content:
- Happy New Year!
- SDTM-ETL v.1.5 released
- SDTM-ETL for OpenClinica Users
- XML4Pharma at the DIA Euromeeting Geneva
- CDISC German-speaking User Group Meeting
- The future of the ODM standard
- Cool Technology: Open Data Kit (ODK)
Nr.37: November 2010
Content:
- CDISC North American Interchange
- The FDA at the CDISC Interchange
- German-speaking User Group Meeting
- End-of-year discount action for our software products 25% off
- A Schematron for ODM
- ODM-extension for the Study Design Model (SDM)
Nr.36: September 2010
Content:
- ODMDesigner 2010-R2
- SEND v.3.0 for public review
- German-speaking User Group Meeting Berlin 28.9
- ODM wiki
- XML4Pharma at the DIA 2011 Geneva Euromeeting
Nr.35: June-July 2010
Content:
- CDISC European Interchange
- ODM version 1.3.1
- A new, strongly improved version of the ODM Viewer is now available
- CDASH User Guide for public review
- CDASH v.1.1 for public review
- CDISC Metadata Submission Guidelines v.1.0 for public review
- News from the FDA front
- SDTM-ETL(TM) and ADaM support
Nr.34: March-April 2010
Content:
- FDA: No HL7-XML for SDTM submissions for the foreseeable future
- CDISC publishes draft pharmacogenomics domains
- XML4Pharma at the CDISC European Interchange
- SDTM-ETL v.1.4
- SDTM-ETL Light
- OpenCDISC 1.0 released
- CDISC ODM Designer Release 2010
- Chiba XForms is now BetterForm
- OpenXData: a mobile solution for clinical research?
Nr.33: January 2010
Content:
- January edition 2010
- CDISC publishes ADaM 2.1 and AdaM-IG 1.0
- SDTM-ETL software to provide support for ADaM
- CDISC publishes document "XML Schema Validation for Define.xml"
- ODM 1.3.1
- FDA changes direction about future transport format for SDTM submissions
- So, what to do?
- An alternative proposal
- Transforming ODM into SAS Transport 5
- CDISC publishes new CDISC Glossary v.8.0
Nr.32: November 2009
Content:
- ODM 1.3.1 for review
- SDTM-ETLTM v.1.3 final now available
- SDTM-ETLTM v.1.3 special offer
- Fully redesigned version of the ODMChecker is now available
- The ODM Wiki
- Akaza Research releases OpenClinica 3.0
- ODM, define.xml and XML-Schema 1.1
- CDISC publishes BRIDG 3.0
- CDISC publishes new Controlled Terminology
- OpenEHR starts cooperation with SNOMED-TC
- FDA starts accepting SDTM 1.2
- The pharao and his disease
Nr.31: September 2009
Content:
- SDTM-ETLTM v.1.3-beta now available
- New ODMViewer version available
- RPE Retrieve Protocol for Execution: a new IHE profile
- The success of OpenClinica
- Standards: can we learn from OpenTravel?
- The future of the ODM Checker
- EHRs, CDISC ODM and Veterans Affairs
- German CDISC User Group Meeting
Nr.30: June-July 2009
Content:
- New version of SDTM-ETL TM now available
- New version of the ODM Study Designer available with CDASH
- CDISC Intrachange
- XML-Schema 1.1 is coming
- DataSci versus Medidata (again)
- Flexcipio and BioClinica obtain ODM certification
- CDISC-EHR integration the next step
- Roche chooses for Medidata (and for ODM?)
Nr.29: April-May 2009
Special Edition: CDISC European Interchange
Content:
- CDISC published SDTM 1.2 and SDTM-IG 3.1.2
- Protocol Representation Group publishes draft of Protocol Representation Model v.1.0
- The CDISC European Interchange day 1 and 2: SDTM Training Course
- CDISC European Interchange the German User Group Meeting
- CDISC European Interchange the main conference
- CDISC European Interchange the XML4Pharma booth
- Some afterthoughts triggered by the CDISC European Interchange
Nr.28: February 2009
Content:
- CDASH is out and hot!
- CDASH and EHR Integration
- CDISC-EHR Integration: first commercial system goes life
- CDISC European Interchange 2009
- CDISC German-speaking User Group Meeting, February 19, Berlin
- Schematron and XML-Schema version 1.1
- Initiative for an ODM extension for ePRO
- HL7-v3-XML messages for SDTM submissions
Nr.27: July-August 2008
Content:
- XML4Pharma's ODMDesigner receives CDISC ODM Certification
- CDISC European Interchange 2008
- CDISC German-speaking User Group Meeting, September 2, Basel
- CDISC and HL7-XML messages
- CDISC and electronic signatures and certificates
- Initiative for an ODM extension for ePRO
Nr.26: November-December 2007
Content:
- CDISC International Interchange Bethesda
- XML4Pharma at the CDISC Interchange
- David Iberson-Hurst joining the CDISC organization
- CDISC SEND group reestablished FDA pilot
- German speaking CDISC User Group
- EHR CDISC Integration demo available
- CDISC ODM and Iternationalization
- SDTM-ETLTM demo at CDISC Interchange
- CDISC European Interchange 2008
- Fast Track receives ODM Certification
- X-Smiles releases version 1.0 of its XForms browser
- DataSci strikes again!
Nr.25: September 2007
Content:
- CDISC International Interchange Bethesda
- XML4Pharma at the CDISC Interchange
- SDTM-ETLTM 1.1 now available
- CDISC publishes SDTM 1.2 and SDTM-IG 3.1.2 for public review
- FDA launches pilot to submit CRFs in ODM format
- CDISC Controlled Terminology
- For techies: XForms, Ajax and dojo widgets
- First German-speaking CDISC User Meeting
Nr.24: July-August 2007
Content:
- Office closed for summer holidays
- New features of SDTM-ETLTM 1.1
- The CDISC Intrachange
- An interview with Ilya Sterin from Nextrials
- CDISC publishes first ODM certifications
- XForms 1.1 implementations
- Restyling of the XML4Pharma website
Nr.23: June 2007
Content:
- SDTM-ETLTM 1.0 now available
- XML4Pharma at the CDISC European Interchange
- CDISC publishes Controlled Terminology
- XClinical and ClinPhone receive ODM Certification from CDISC
- XML4Pharma CDISC Implementation Services
- New version of the ODM Viewer available
- New version of the ODM Study Designer available
- Nextrials bases EDC system on native XML database
- New software offering: the Define.xml Checker
- Mozilla Foundation makes version 0.8 of XForms plugin for Firefox available
- XMLNotePad 2007
Nr.22: March 2007
Content:
- SDTM-ETL: mapping ODM to SDTM
- CDISC European Interchange
- CDISC end-to-end
- Upgrades of ODM Viewer and ODM Study Designer
- XQuery becomes a W3C Recommendation
- The future of the CDISC ODM Checker
- New CDM System based on CDISC ODM and native XML database
- XML4Pharma and EDC Vendors
Nr.21: January 2007
Content:
- Happy New Year !
- CDISC publishes ODM 1.3 Final
- DIA Basel November 2006
- Consolidation in the e-Clinical world ?
- Business Case for CDISC Standards
- Sylva collins to join Kendle
- IBM goes for XForms
- XML4Pharma launches new EDC technology based on ODM 1.3 Standard
- XML4Pharma develops Java widgets based on ODM 1.3 for use in EDC
Nr.20: October 2006
Content:
- EDC threatened by dubious patent ?
- The Changing World of Clinical Trials, DIA Basel, November 2006
- ADam 2.0 released by CDISC
- Our latest article in Applied Clinical Trials
- Consolidation in Europe's drugs sector
- The CDISC ODM Checker as a server application
- The ODM Study Designer v.1.1
- The ODM Study Designer and future CDISC Standards
Nr.19: May-June 2006
Content:
- CDISC published ODM 1.3 for review
- XML4Pharma at the Berlin CDISC European 2006 Interchange
- The ODM Study Designer now launched
- EDC, XForms and Ajax
- Does Oracle Clinical go CDISC ?
- CDISC ODM Checker v.0.7 now available
- XForms 1.0 Second Edition is now a W3C Recommendation
Nr.18: March 2006
Content:
- CDISC to publish ODM 1.3
- EMEA makes PIM Light Authoring Tool (LAT) available
- European CDISC 2006 Interchange
- XML4Pharma to give seminar at the CDISC Interchange
- The ODM Study Designer
- XML4Pharma starts Semantic Web activities
Nr.17: January 2006
Content:
- Happy New Year !
- CDISC 2006 Interchange
- eCliniqua predictions for 2006
- Achieving Cost Savings using EDC Effectively
- FDA updates XML-Schema for SPL
- The new ODM Study Designer
- CDISC Glossary version 4 available
- ODM on your PDA ?
Nr.16: November 2005
Content:
- A new tool for designing clinical studies in CDISC ODM format: the ODM Study Designer
- Four Worlds One Vision: DIA Conference Prague
- CDISC Lab Standard Implementation
- CDISC ODM 1.3: new features and enhancements
- Automatic generation of eCRFs from ODM study setups : technology now generally available
- CDISC ODM Checker v.0.6 now available
- IBM Releases XForms Generator
Nr.15: September 2005
Content:
- Lincoln Technologies acquired by Phase Forward
- Update of the CDISC ODM Viewer soon available
- Improvements on the XML4Pharma Demo Application Server
- Deutschsprachiger Kurs όber CDISC ODM und define.xml
- The CDISC ODM Viewer
- Oracle and XQuery
- CDISC US Interchange
- News from the CDISC ODM Team
- Oracle makes JDeveloper IDE available for free
- Altova and XMLSpy heavily criticized
Nr.14: May 2005
Content:
- CDISC Interchange 2005 - Paris
- News from EMEA: new version of PIM
- New brochure available on tools for working with CDISC ODM, Lab and Define.xml
- The FDA publishes about the use of the CDISC define.xml standard
- Interactive eCRFs and the CDISC ODM standard
- The new ODM extension mechanism: new sample files available
- Archiving clinical data and ODM file sizes
Nr.13: March 2005
Content:
- XML4Pharma develops CDISCLabChecker for Gereq
- The ODMViewer is back !
- XML4Pharma at the 2nd European CDISC Interchange in Paris
- News from CDISC: the new ODM extension mechanism
- CDISC, eCRFs, XForms and PDAs
Nr.12: January 2005
Content:
- Happy New Year
- Eight tools for working with CDISC standards now available online
- Adobe PDF forms and XForms: competitors or allies ?
- News from CDISC: the define.xml standard, and a new ODM extension mechanism
- Oracle declares war to native XML databases ?
Nr.11: November 2004
Content:
- A new tool: CDISC Lab ASCII to Lab XML Converter
- New applications on our demo application server
- The final version of the new CDISC define.xml standard
- The CDISC ODM and Lab Implementation Workshop
- XML4Pharma at the DIA e-Clinical Interchange in Washington
- Best Practices: Web-based CRF saves Wellspring 30 percent over paper records
Nr.10: September 2004
Content:
- CDISC ODM & Lab Implementation workshop: registration now open
- GAML is dead ! Long live AnIML !
- New standards from CDISC
- Some improvements on the XML4Pharma application server
- Freely available for CDISC members: the ODM Checker v.0.5
- XML4Pharma teaching at the October DIA Meeting in Arlington (VA)
Nr.9: July 2004
Content:
- CDISC ODM and Lab Implementation Workshop - Munich, September 30
- LIMS and XML
- New applications on the XML4Pharma application server
- The ODM Checker v.0.5 is now available
- Oracle Clinical and CDISC XML
- The XML4Pharma application server and automatic creation of eCRFs
- Native XML databases
- XML4Pharma at the October DIA meeting in Arlington
Nr.8: May 2004
Content:
- The XML4Pharma Application Server is now up and running !
- CDISC European Interchange
- Oracle Clinical and XML
- Automatic creation of eCRFs
- The XML4Pharma application server and automatic creation of eCRFs
- Native XML databases
Nr.7: March 2004
Content:
- XForms: our services
- Soon available: upgrade of CDISC ODM Checker
- In progress: the XML4Pharma application server
- CDISC Protocol standard underway
- First European CDISC Interchange
Nr.6 : January 2004
Content:
- Move of XML4Pharma to Germany in completion phase
- Bristol-Meyers Squibb chooses for XForms
- Final CDISC ODM 1.2 released
- Java 1.5 is coming !
- Transforming XML documents into Excel Worksheets
Nr.5 : November 2003
Content:
- XML4Pharma gives Web Services course at InfoTechPharma 2004
- CDISC releases ODM 1.2
- XML4Pharma moving to Germany
- CDISC-ODM Checker now available
- XML implementation of the CDISC Lab Standard released
- XForms makes it to a W3C Recommendation
Nr.4 : July 2003
Content:
- XML4Pharma is a "CDISC Registered Solutions Provider"
XML4Pharma has recently received certification as a "CDISC Registered Solutions Provider".
By this certification, CDISC endorses that XML4Pharma is experienced in the implementation of CDISC standards.
- Now available: the CDISC ODM Checker (test version)
The CDISC ODM Checker is a tool to check whether an ODM file is conform the standard.
The tool goes far beyond that of traditional XML checkers, as it also checks whether the data in the ODM file
are consistent, even when the ODM file is only incremental.
The ODM Checker will be made available for free to CDISC members.
- 21 CFR Part 11 and XML
Can your company ensure that all its electronic data are still readable by the FDA in 20 years from now ?
Discover how XML can help you to archive data in an open-standard, vendor-neutral format.
- Brookhaven Database goes XML
The well known PDB database, containing all known experimentally determined protein structures, now
makes these structures available in XML format.
Nr.3 : April 2003
Content:
- XML4Pharma at the Pharma IT Summit and at IT Pharma Solutions 2003
- CDISC soon to release XML-Schema for Lab standard
- XML4Pharma develops CDISC-XML-Checker
- Web Services
- Presenting: Generalized Analytical Markup Language (GAML)
- The eCTD (v.3) in table form: new version available
Nr.2 : December 2002
Content:
- XML4Pharma at InfoTechPharma 2003
- XML4Pharma courses
- XML4Pharma and CDISC
- The eCTD: publication of final release
- All you need is SOAP
- ODM Editor and Reporter
- Oracle announces XML DB and SQL/XML
- Latest news: CDISC publishes production release of Lab standard
Nr.1 : August 2002
Content:
- XML4Pharma lectures at international eCTD course
- Website in XHTML
- XML4Pharma invited to give post-conference course at InfoTechPharma 2003
- XML4Pharma tips: filtering in XML
- Volunteering at CDISC
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