15 New England Executive Office Park
Burlington, MA 01803, USA
Contact Person: Nicola Rogerson, Marketing
Clinical Trial Design, Consulting, Data Management, Database Conversions, Electronic Data Capture, Electronic Submissions Preparation, Programming (Database/SAS/etc), Software Development & Evaluation
Formedix is a leading provider of software and consultancy services based on emerging data standards developed by the Clinical Data Interchange Standards Consortium (CDISC).
Since our inception in 2000, Formedix has delivered CDISC software and services that have resulted in time and cost savings in every key area of the clinical trial process from study set-up through to submission.
Formedix launched the first CDISC Study Design Tools, Origin Study Modeller™ and Origin Submission Modeller™ which output CDISC Database Metadata (Operational Data Model, (ODM) and Submission Metadata (CRT-DDS, define.xml) to streamline the creation of database and dataset specifications. Origin Study Modeller™ has been proven to deliver a three fold reduction in study database design time and is used by market leading biotechnology, pharmaceutical and medical device companies worldwide.
In addition, to our Origin™ Study Design tools Formedix has a data transformation engine which replaces manual programming effort with a CDISC metadata driven conversion process. Now the production of proprietary and CDISC Study Data Tabulation Model (SDTM) datasets from any type of raw data source is simple and scalable.
Formedix are one of the oldest members of CDISC with CDISC Registered Solution Provider status and representation on the CDISC Industry Advisory Board. Our lead CDISC consultant contributes to the ODM Technical Team where he won two CDISC awards for furthering development of this model.
Formedix was one of the first implementers of the content standards developed by the Clinical Data Acquisition Standards Harmonization (CDASH) initiative producing ODM forms, presenting at conferences/webinars and delivering training sessions on how best to implement CDASH alongside other CDISC models.
As well as our suite of CDISC software solutions, Formedix offers a comprehensive range of CDISC Planning, Preparation and Implementation Consultancy services which are designed to help a Company at any point in their CDISC adoption cycle