Since 2001 we have been members of CDISC, and soon after joined the CDISC Operation Model (ODM) and CDISC Define-XML teams. More recently, we became founding members of the CDISC XML Technology Governance team that oversees the technical direction of CDISC standards. We've added some impressive awards to our collection for our contribution to the standards.
Our solutions are aligned to CDISC standards and are used to standardize study designs and create more efficient studies. We've worked with organizations to streamline their clinical trial processes since 2000 and have proven significant time and cost savings each time.
Organizations working with Formedix leverage our experience to prepare submissions to regulatory bodies such as the FDA, EMA and PMDA. With extensive experience of CDISC standards and regulatory submissions, our expert team are well placed to help and advise you on your next submission.
We're regularly involved in:
- Introducing standards and providing training
- Designing and converting CDISC SDTM, ADaM and SEND datasets
- Creation of submission deliverables such as Annotated CRFs, Define-XML and Define.PDF files
- Creation of Study Data Reviewer's Guides, providing advice on reviewer's comments and questions.