Formedix can introduce CDISC into your clinical trials process helping your organisation's drug development programs and business in several key areas as described below. 

• Take advantage of CDISC's Domain Knowledge and Reduce Submission Design and Case Report Form Development Effort - CDISC have defined all the safety domain datasets and variables that are required to support the submission of your latest drug.  These datasets can be used off the shelf enabling more efficient deployment of internal resources and/or cutting down on the use of costly external consultants.  Furthermore, additional study specific datasets are easy to define using the concepts contained within the CDISC Submission model.  Standardized case report forms corresponding to the safety datasets are also under development under a CDISC initiative entitled Clinical Data Acquisition Standards Harmonization (CDASH) which will bring the same advantages to CTF development as highlighted above.
• Control External Technology Vendors and Contractors (EDC vendors, CROs and Laboratories) - Upfront study specification of CRO clinical data management and/or EDC requirements is often a tedious, manual and time consuming affair involving hand creation of database specifications in Microsoft Excel and manual form layout in tools such as Microsoft Word.  Now, with the use of tools such as Origin Study ModellerTM your organisation can design CRO/EDC specifications and produce machine readable CDISC  Operational Data Model (ODM) metadata which is used to dynamically create human readable reports such as case report forms, event/form matrices and database specifications tailored to different members of the study set-up team.  These specifications are quicker and easier to produce and easier to review leading to shorter review time and less review and approval cycles saving time and money.  Easier to understand specifications also have the effect of reducing CRO/EDC vendor rework - how many times have you delivered clear specifications that were incorrectly implemented leading to costly rework and time overruns?  Now you have control over your external contractors and can machine check the quality of their database builds and/or the datasets delivered by your CRO/EDC partner against he specification you originally delivered.
• Vendor Neutral Design Libraries and Export Formats Deliver Clear Advantages - The establishment of vendor neutral CDISC based libraries of database and submission design content makes the creation of subsequent studies quicker and easier.  Furthermore, you will no longer be tied to a particular CRO or technology vendor due to proprietary import or export formats and can choose best in class vendors who consistently deliver quality solutions on time and on budget.
• Delivery of Submission Data in a Partner/Regulator Neutral and Friendly Format - Are you facing delays in securing milestone payments or regulatory approval due to difficulties with your partners or the FDA understanding the variables or arrangement of your clinical trial datasets?  Adopting the CDISC SDTM submission format for your clinical trial dataset structures ensures that there will be no ambiguities since datasets, variables and controlled terms are all documented within the CDISC standard.  The FDA is keen to welcome new adopters of the CDISC SDTM prior to regulation, and delivery of submissions in this format will help to expedite review times.