Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Ed Chappell
Solutions Consultant, UK
Keynote: J Clin Trials
Now you can, with our off-the-shelf clinical metadata repository (MDR) and clinical trial automation platform. We’ve taken away those time-consuming and expensive manual tasks - from study set up to submission. Our clinical MDR provides a central home to govern your organizational standards. Here you can manage, update, approve and share organizational standards. Even import existing content – standards, studies, forms and datasets - from your EDC and e-clinical databases. And by building your standards library in a central MDR, you can easily reuse content across studies and standards. Think about all the time and resources you’ll save not having to retype and duplicate content many times over. What’s more, the Formedix platform is built on CDISC standards. Both current and previous versions of CDISC are supported. So you know you’ll always comply with the relevant regulatory requirements. And if you need help automating study design and build, we can do that too. Our clinical trial automation tools use the content in your MDR to build your studies much faster. Whether you want to design eCRFs, build EDCs, design or convert datasets, or make define files… Formedix helps you do it in a fraction of the time.
• Easily create, maintain & reuse standards in 1 library
• Comply with latest & previous CDISC standards
• Easily automate CRF annotations & EDC builds
• Convert datasets to SDTM in 1 click
• Start right now, it’s off-the-shelf – no complex implementation
Ed Chappell has been with Formedix for over 12 years as a Solutions Consultant. He has authored and presented the Formedix training courses for SEND, SDTM, Define-XML, ODM-XML, Define-XML and Dataset-XML. Ed has been heavily involved in the development of the Dataset Mapper ETL language. He has also led the Formedix clinical data programming team which includes Interim Analysis (IA) SDTM and FDA SDTM clinical submissions.