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XML4Pharma, a consultancy and software development company specializing in the implementation of CDISC standards, is happy to announce major new releases of two of its software products.
These new releases will be presented at the CDISC European Interchange, which takes place from April 20 to 25 in Budapest.
A new release (2009-R1) is announced of the by CDISC certified software package “CDISC ODM Study Designer”. This new version of our popular study designer fully implements the CDASH standard, i.e. it comes with a library of CDASH forms which can be added to the study design with a few mouseclicks only. Even after that, the forms can be edited and extended. Furthermore, many new features and enhancements have been added to the software.
A new release of the SDTM-ETL software (TM) will also be presented at the CDISC Interchange. SDTM-ETL is a software package to map operational clinical data (using the ODM standard) to submission data (SDTM standard), with at the same time, automatic generation of the define.xml file. The mapping can then be used to generate the SDTM datasets (SAS XPT format), or to generate and populate an SDTM database. The new version has many new features, making it even more easy to design and execute mappings between operational data and submission data, in an extremely user-friendly way.
Furthermore, XML4Pharma will give a presentation at the CDISC Interchange, titled “Integration of EHRs with CDISC, CDASH and ODM – A European Initiative”, and will be involved in the SDTM training given on day 1-2.
XML4Pharma, a consultancy and software development company specializing in CDISC standards,
today announced that its ODM Study Designer software has been certified by the Clinical Data Interchange Standards consortium (CDISC) as complying with the Operational Data Model (ODM) standard.
The ODM Study Designer is the first clinical study design tool that receives certification for all four metadata (study design) use cases.
The ODM Study Designer allows to set up clinical studies according to the CDISC ODM standard. Unlike other study design tools, it does not only export study designs in ODM format, but also imports study designs in ODM format from other sources. This makes it the product of choice for collaborative work involving clinical study design. Furthermore, the ODM Study Designer is the only software offering sofar that fully supports all vendor extensions to the ODM standard, according to the ODM Vendor Extension Mechanism.
With the full certification of the ODM Study Designer by CDISC, the pharma industry now has a software tool available for the set up and exchange of study metadata and study designs that is guaranteed to be fully compliant with the CDISC ODM Standard.
CDISC has published the final version of the ODM Standard version 1.3.
After a one and a half year of hard work, the CDISC ODM Team has published a new version of the ODM Standard.
This new version has many new features and enhancements, especially for EDC, improved data transmission and electronic submissions.
The standards document, XML-schemas and example files can be downloaded from the CDISC website.
Information about the new exciting new features and enhancements is available on our ODM 1.3 web page
EMEA has recently released its "Light Authoring Tool" (LAT) to help pharma companies assembling Product Information Management (PIM) files in electronic (XML) format.
More information on the LAT and support services by XML4Pharma is given on our PIM web page
Lincoln Technologies, a US based major provider of IT products and services for clinical trials and regulatory submissions, and a great advocator of the CDISC standards, has been acquired by PhaseForward.
According to PhaseForward: "Lincoln Technologies will be an engine for innovation for Phase Forward".
Until now, PhaseForward has not been able to implement the CDISC standards in its product offerings (ClinTrial, InForm), and this might exactly be the reason for the acquisition.
With the acquisition, ClinTrial users may finally start to hope for a CDM System that allows for import and export of CDISC ODM and Lab files.
More information about the acquistion may be found on the websites of PhaseForward and Lincoln Technologies
The Submission Data Standards (SDS) Team of the CDISC received the Food and Drug Administration’s Leveraging/Collaboration Award at the Office of the Commissioner Honor Award’s Ceremony on 10 June 2005. The award was given to CDISC for the “creation of the standard Study Data Tabulation Model (SDTM) and accompanying implementation guide for submission of data tabulation datasets to the FDA.”
The award, presented by Acting FDA Commissioner Lester Crawford, was accepted by Mary Lenzen and Wayne Kubick on behalf of the entire SDS team.
XML4Pharma congratulates the whole SDS Team for this FDA acknowledgement of their formidable effort to develop a standard for data tabulation datasets.
More information can be found on the CDISC website.
The CDISC Define.xml team has now released the final version of the "Case Report Tabulation Data Definition Specification" standard, better known as "define.xml", as it replaces the classic "define.pdf" file.
Companies that submit their CRT data definitions in this new format are expected to get a considerable advantage, as the new format allows the FDA to treat the data much faster.
XML4Pharma actively participated in the development of the technical part of this new standard, and will in near future start with the development of tools for working with define.xml files. New tools already envisaged are: a Checker tool, and Builder tool.
The final version of the define.xml (CRT-DDS) standard can be found on the CDISC website.
The ODM 1.2 has some provisions for Vendor Extensions, using the xs:any and xs:anyAttribute mechanism of XML-Schema. The disadvantage of this however is that the extensions themselves cannot be checked against their own XML-Schema.
As the define.xml team wanted to build the XML implementation of their standard as a "Vendor Extension" to the ODM, the question came up how a define.xml file could then be checked against the standard. Therefore, Anthony Friebel from the SAS institute, constructed a considerably improved XML-Schema for the ODM 1.2, which allows import of "Vendor" XML-Schemas, so that tools to check "extended" ODM files (such as the define.xml) can easily be developed.
As a contribution to this effort, XML4Pharma constructed and tested a number of example extensions, such as an extension to incorporate XML-elements from the CDISC Lab standard into a standard ODM file.
With the excellent knowledge of this new extension mechanism, XML4Pharma can now give vendors full support in the implementation of this new technology, including the development of XML-Schemas to extend the CDISC ODM 1.2.
Details about the new extension mechanism for the ODM 1.2 can be found on the CDISC website
XML4Pharma recently released a tool for converting CDISC Lab files in ASCII format into CDISC Lab files in the more covenient XML format.
Read the press release here:
The Drug Information Association has asked Jozef Aerts of XML4Pharma to give a basic CDISC XML workshop at the joint DIA - CDISC meeting
(titled: e-Clinical Interchange: From Clinician to Submission) in Arlington on Monday, October, 18th.
The workshop will give the participants a basic introduction to CDISC XML, XML-Schema, and XSLT for transforming XML documents.
The FDA has announced that the Study Data Tabulation Model, developed by CDISC, is now accepted as a standard for submitting data to the agency. In its press release the FDA states:
The importance of a standard for the exchange of clinical trial data cannot be overstated,” said Dr. Lester M. Crawford,Acting FDA Commissioner. “FDA reviewers spend far too much valuable time simply reorganizing large amounts of data submitted in varying formats. Having the data presented in a standard structure will improve FDA’s ability to evaluate the data and help speed new discoveries to the public
A PowerPoint presentation from the FDA about the importance of data standards can be found here.
The FDA press release can be found here.
Jozef Aerts of XML4Pharma has been invited to give 2 workshops at the European CDISC Interchange conference
which takes place from May 9-11 at the the Chateau Du Lac, near Brussels.
The first workshop, given on Sunday, is a general XML workshop, learning the attendees the principals of XML.
The second workshop, given together with Dave Iberson-Hurst (Assero) is a CDISC Implementation workshop.
This workshop gives the participants a jump-start in the technical implementation OF CDISC ODM and Lab, through examples,
demos, and source code that is delivered during the workshop.
CDISC has now released the proposal for the 1.2 version of the ODM (Operational Data Model).
This new version is fully downwards compatible with the 1.1 version, but has also some major improvements.CDISC, the Clinical Data Interchange Standards Consortium,
has accepted the application of XML4Pharma - Computer Chemistry Consultancy to become a "CDISC Registered Solutions Provider".
This means that CDISC recognizes the capabilities of XML4Pharma to provide quality services related to the CDISC set of
standards, and especially in relation to the ODM, the (XML based) operational data model for exchange of clinical data.
XML4Pharma - Computer Chemistry Consultancy has been working with the ODM for over a year now, has performed
technical implementations of the ODM, and has developed a number of tools and products to work with the ODM.
We are currently transforming our website from good old fashion HTML to the new XHTML
standard. Why ?
First of all, as XML evangelists, we have to give the good example.
Secondly, moving to XHTML gives a lot of new possibilities. For example, it is easier to
transform an XHTML file to a JSP file. You can use an XML editor to do this, and your JSP will
automatically be checked for well-formedness and validity. This surely accelerates the development of
JSP pages (who loves it to debug JSP files ?)
XML4Pharma will give a half day seminar on XML at InfoTechPharma, an important congress about pharmaceutical IT.
Besides XML, other important themes at this years event are grid computing, knowledge management and BioInformatics.
Computer Chemistry Consultancy - XML4Pharma, will lecture at the IBC Life
Sciences course "The Electronic Common Technical Document and Electronic
Submissions" in London on 19-20 September. We will give a lecture with the
titel "What do I need to know about XML to work with the e-CTD?"
The following topics will be handled:
More details about this course and the programm can be found at the IBC Life Sciences website
CDISC, the Clinical
Data Interchange Standards Consortium, announced the release of the final 1.1
version of the Operational Data Model (ODM).
The ODM is a vendor-neutral, open, XML-specification for storing and
exchanging clinical data in clinical trials.
The use of the final ODM v.1.1 will be demonstrated by 30 companies in the
industry at the CDISC Clinical Data Connectathon, held in conjunction with
the DIA Annual Meeting on 18 June 2002 in Chicago.
The final version has a number of changes relative to the draft version. This means that old ODM files (made using the draft specification) do not comply anymore with the final specification. XML4Pharma however, has developed a XSLT stylesheet to transform ODM-XML files made under the draft specification, to ODM-XML files which comply to the final 1.1 specification.
The stylesheet is freely available for download.
XML4Pharma - Computer Chemistry Consultancy will be present at the CTD Practical
course organised by IBC LifeSciences, in Friedrichsdorf/Bad Homburg
(Germany), on April 22 and 23. This two day training course also contains an
afternoon session on the e-CTD (the electronic Common Technical Document), which
is in XML-format.
For people in Regulatory Affairs departments this is an ideal opportunity to
learn about the CTD and to meet people and companies providing services in
relation to the eCTD, such as XML4Pharma.
XML4Pharma has been selected by the
organizers of InfoTechPharma 2002 to give the conference course on XML on February 12th in London.
InfoTechPharma is the world annual meeting place for R&D and production
informaticians working in the pharmaceutical industry. Last year, the
InfoTechPharma was attended by over 300 participants from the pharma and
biotech industry. It is regarded as the most important meeting in the field
in Europe.
This year's conference has sessions on Strategy, In Silico Biology, Infrastructure, Regulatory Affairs, ChemInformatics, Architecture & Planning, eClinical, Alliances & ASP's, Information Management and on Compliance & Validation.
Speakers include CIO's, VP's and directors from AstraZeneca, Novartis, Pfizer, GSK, Hoffman La Roche, Wyeth-Ayerst, Schering Plough and Bayer.
The conference is accompanied by an important exhibition with almost 40 exhibitors.
The Food and Drug Administration (FDA) announced a CDER Patient Profile pilot project using the CDISC Submission Domain Models. Volunteers will be chosen involving the testing of the Patient Profile Viewer, software that allows a reviewer to display data collected from case report tabulations (CRTs) submitted in electronic format. The CDISC Submissions Data Model (SDM) is the second of a series of new open standards developed by CDISC. CDISC is regarding XML-technology as the enabler of new, open standards for information exchange. More information can be found at the CDISC website.
The Clinical Data
Interchange Standards Consortium (CDISC) has released Operational Data
Model (ODM) Draft V1.1 for public comment. The ODM is a new XML-standard,
allowing Pharmaceutical Companies the archiving and exchange of clinical
trials data with study metadata. The ODM contains the essential elements to
transmit most information about the conduct of a clinical trial. Third
parties (pharmaceutical companies, software vendors) are however allowed (and
encouraged) to extend the new standard for special cases.
XML4Pharma believes
the release of this ODM is a major step in efficiency improvement of clinical
data acquisition and exchange. Unlike earlier "standards", this is not a
propriety standard. As it uses all the power of XML, this standard is open,
human-readable, contains the metadata, and is extensible.
Moreover, it is widely supported by the pharmaceutical industry: version 1.0
was implemented by 23 companies in a proof-of-concept in July 2001.
XML4Pharma will surely support and evangelize this new
standard.
After the FDA made demonstration software available for creation of "Cumulative Table of Contents" in XML format (TOCeditor) in January, it recently presented a prototype standard method for reporting stability data in electronic format using XML. The complete information about this tool can be found at the FDA website
A demo is included (Internet Explorer required).
