Formedix can help you introduce CDISC into your clinical data management and biostatistics operations enabling you to satisfy clients' CDISC requirements within RFPs.  Furthermore, CDISC enables several key quality and efficiency benefits in many areas of your data management and biostatistics operations resulting in greater customer satisfaction and retention.  Just some of the areas in which CDISC can help you and your clients are as follows:-

• Study Specification - With the use of tools such as Origin Study Modeller^TM your organisation can design EDC/CDM systems 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 to produce and and easier to review leading to shorter review time and less review and approval cycles enabling you and your client to move more rapidly onto study execution.
• Establish libraries of Database and Submission Design Content - This makes the creation of subsequent studies quicker and easier for your clients.  Furthermore, if you store and maintain these libraries for your clients they will be less likely to move to an alternative contract research organisation in the future.
• Delivery of Raw Data and Submissions Data in a Client Neutral Format - Are you tired of supporting the myriad of formats and dataset configurations for each and every one of your clients?  Chances are that your clients are tired of specifying and testing that each and every one of the datasets and variables you have delivered exactly matches their own specification.  Adopting the CDISC SDTM submission format for dataset structures ensures that there is no ambiguity in what you have delivered, automation can be introduced to produce these datasets and quality can be machine tested rather than manually tested.  A win-win for all in terms of efficiency and quality, enabling your organisation to scale more effectively and serve more customers with fewer resources. 

Whether you have started down the road of CDISC adoption or are new to the standards we would love to come and speak to you to talk about CDISC, the benefits of the standards and to share our experience and expertise in implementing CDISC.  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it  to make an appointment today.