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FORMEDIX LAUNCHES DEFINE.XML TOOL
Formedix launches OriginTM
Submission Modeller, its Define.xml authoring tool and the latest
addition to the successful OriginTM Suite of products.
Burlington, MA – February 2008 - Formedix, a leading supplier of standards-based electronic trial solutions for the pharmaceutical industry,
announces the release of Origin™ Submission Modeller, its first
Define.xml authoring tool.
As one of a select list of Registered CDISC
Solutions Providers, Formedix, with its CEO Mark Wheeldon, has been an active supporter of the CDISC led drive for the global adoption of data standards in clinical
trials.
Mark said:
"Our new product, Origin™ Submission
Modeller, is the latest addition to our Origin™ suite of products
which have been proved to save our clients time and money.
It is used for the design of datasets and produces
human readable submission specifications and machine readable CDISC
Submission Metadata. It allows both authoring and management of
Define.xml files. Users are able to produce these without any
knowledge of XML, through use of a simple graphical user interface.
Furthermore, it enables template-driven dataset
creation which means that users require no knowledge of the CDISC Study
Data Tabulation Model (SDTM) or the Define standard."
Mark explained further:
"Origin™ Submission Modeller supports three
broad classes of templates allowing companies to create datasets that
comply with both the CDISC Study Data Tabulation Model and in-house
proprietary datasets.
A template based approach is brilliant in that it
allows for complete flexibility within the tool - now whenever changes
are made to the underlying CDISC standard we simply ship a new template
to our clients and they can create domains compliant with the latest
version of the standard. No more time spent mapping the changes
between , say version 3.1.1 and 3.1.2 - Origin™ Submission Modeller knows
all the changes and guides the user.
Another really neat thing is the ability for
customers to design their own implementation guides - that is their own
version of the CDISC standard - which not only complies with the core
CDISC standard but allows them to add new functionality such as their
own internal controlled terminology.
These templates ensure that, as people design
studies, they are not only CDISC compliant but match with your own
internal content standards, thereby maintaining a degree of governance and content standards
compliance. Naturally the product allows the storage of whole
libraries of datasets in a Define.xml format.
Formedix's consultancy services are often engaged
to convert proprietary metadata to Define.xml structures which, whilst
stored in a CDISC format, do not use variable naming conventions set
forth by CDISC. Now designers can benefit by being able to drag
and drop design not only CDISC SDTM based studies but also studies which
use their in-house proprietary standards.
The end result is more rapid development of
datasets which fit with your current in-house process but are also
future-proof for CDISC SDTM compliance. The tool has the
capability of producing human-readable specifications such as
Define.html which can be passed to external Contract Research Organizations
to give a clear description of exactly what you expect delivered
datasets to look like, increasing quality in your outsourced
clinical trials program."
Origin™ Submission Modeller is available for
immediate release and interested parties are invited to contact Formedix
to download a demo. It joins Origin™ Study
Modeller, Formedix's Clinical Trial Authoring and Specification Tool based on CDISC’s Operational Data Model
ODM, further strengthening the company's product and service
offerings which have been proven time and time again to save their
clients time and money.
About Formedix
Formedix develops enterprise pharmaceutical software solutions for the conception, generation, delivery and integration of electronic and paper-based clinical trials. By eliminating paper (where appropriate) and building upon industry data interchange standards such as CDISC, powerful Formedix software technologies significantly reduce both the cost of clinical trials and more importantly their duration, which is the critical path in drug development. Formedix has offices in the USA and UK and their customers include market leading pharmaceutical companies in the UK, USA and Europe.
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