Formedix Launches Origin™, the First CDISC Based Trial Specification and Authoring Environment.

By radically streamlining the clinical trial specification process, Origin Study Modeller™ allows companies to slash study set-up time by at least 50%.

GLASGOW, UK – June 16th, 2003 - Formedix, a leading supplier of standards-based electronic trial solutions for the pharmaceutical industry, is pleased to announce the launch of Origin™, the first clinical trial specification tools based on CDISC XML data standards, at the Drug Information Association’s (DIA) 39th Annual Conference to be held on 15–19 June at San Antonio, Texas.

The first product in the Origin™ suite, Origin Study Modeller™ enables companies to significantly reduce the cost and length of their clinical trials by markedly decreasing the upfront study set-up time. Origin Study Modeller™ provides an electronic trial specification and authoring environment in which all trial role-players can work in parallel to read, edit, define, share and manage trial designs, hence streamlining the trial creation process.

Origin Study Modeller™ is the first commercially available tool that allows users to capture the content and structure (metadata) of their clinical databases in CDISC Operational Data Model (ODM) format. ODM is the emerging pharmaceutical industry data standard created by the Clinical Data Interchange Standards Consortium.

Mark Wheeldon, Formedix CEO, said:

“Presently most clinical trials are designed on paper by multi-disciplinary teams working in a sequential and time-consuming way. Each time a new trial comes along it’s like re-inventing the wheel; the whole process is laborious and error prone. However, through the pioneering work of CDISC, the situation is certainly improving. CDISC is developing electronic data models to support the global standardisation of clinical trial data acquisition, exchange, submission and archiving. 

“Standards such as these only become truly useful though when tools and services appear to implement them. Formedix’s Origin Study Modeller ™ is the first trial-authoring tool that enables users to describe and capture the content and structure of a clinical trial database and output it in a portable format that is fully compliant with the CDISC ODM1.1. Furthermore, our engineers have incorporated a straightforward drag and drop interface that allows trial personnel to easily produce specifications without requiring knowledge of XML or the underlying Operational Data Model”. 

The US Food and Drug Administration (FDA) have recently endorsed the use of CDISC models commenting that “innovation depends on standardisation”. Origin™ fully implements CDISC data standards to optimise trial specification and facilitate reuse of valuable trial design content in future trials. For the first time all trial role-players will be able to work in parallel within a clear, globally understood framework. 

The new software has been in development for over two years and has already been successfully trialed by a number of pharmaceutical companies. Benchmarking data from these trials showed that by using Origin Study Modeller™ an average 50% reduction in trial specification time is achievable.

Mark added:

“Process optimisation is vital for any drug company, whether it be during trial set-up, implementation or execution. Our standards-based software will help the Pharmaceutical Industry yield greater returns on investment and speed up the process of getting their drugs to market.”

Formedix is also happy to announce that it has recently closed a second round of funding with which it will increase its presence in the US and expand its clinical data standards consultancy and training practice. Utilising Formedix’s expert knowledge in the standards arena, advice and guidance will be provided on business re-engineering and return-on-investment projections for clients who are considering migrating to CDISC data standards.

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.