Joining a select list of only eight other companies worldwide, Formedix has been included in Cdisc's programme of Registered Solution Providers
Formedix, a supplier of standards-based electronic trial solutions for the pharmaceutical industry, is pleased to announce its inclusion in the Clinical Data Interchange Standards Consortium (Cdisc) list of Registered Solution Providers.
The Clinical Data Interchange Standards Consortium (Cdisc) is developing standard data models to define how data should be collected, exchanged and stored during and after clinical trials. As a service for organisations looking for assistance in implementing these data models, Cdisc has compiled a list of suppliers, Registered CDISC Solution Providers, (RCSP) whom they regard as qualified consultants, system integrators and subject matter experts.
Joining a list of only eight other RCSP companies worldwide, Formedix's in-house experts have over 15 years of data standards experience and are ideally placed to deliver a range of professional services to organisations considering the adoption of Cdisc data standards.
Mark Wheeldon, Formedix CEO, said: "As an active supporter of the Cdisc led drive for the global adoption of data standards in clinical trials, Formedix is delighted that Cdisc have added us to their list of preferred suppliers.
We are strongly convinced that the future of clinical data management lies in the industry wide adoption of clinical data standards and so in addition to developing a range of professional Cdisc consultancy and training services, all of our clinical trial software products have been carefully designed to meet Cdisc data standards".
The Cdisc data models can be split into four main categories: the Operational Data Model (ODM) has been developed to support the acquisition, interchange and archiving of operational data; the Submission Data Model (SDM) refers to the standard metadata models being developed to support the data flow from the operational database to regulatory submission.
There are also models covering exchange of laboratory information (the Lab model) and guidelines for the creation of statistical analysis data sets (the Adam model).
Wheeldon explained: "Formedix's lead product, Origin Study Modeller is a clinical trial authoring and specification tool based on Cdisc's operational Data model ODM.
It is the first commercially available multi-user tool that allows a study team to rapidly and collaboratively define the content and structure of their clinical databases and output these designs in the vendor neutral format of the ODM.
Its intuitive interfaces allow Cdisc newcomers and specialists alike to create and manage the specification of any clinical study and easily share it internally or with external partners.
"Furthermore the ability for more than one user to create content concurrently and for different trial role-players to visualise the clinical database in customised styles appropriate to their job function enables all trial personnel to work collaboratively and so reduce trial specification time." In addition to companies using the Cdisc data standards, in particular the ODM, to streamline the upfront specification of clinical trials, there is currently much interest surrounding the use of data standards to expedite the regulatory review and approval cycle for new drug applications.
In anticipation of completion of the imminent FDA guidance document on the use of the latest version of the Cdisc Submission Data Model (SDM), the race is on for vendors who can produce tools to implement this data model.
