Clinical Data Management services provided by IDDI support all aspects of your study from set-up, implementation to submission. From creation of the data management section of the protocol to database lock, IDDI will guide you every step of the way.
- Reduced EDC set-up time, therefore reduced associated costs
- Broad experience supporting various indications and EDC systems
- Fully integrated EDC, IWRS and medical coding
- Robust CFR Part 11 validated web-based tools
- Database structure based on CDISC SDTM (adaptable to any proprietary structure if necessary)
- Efficient integration of external data (e.g. Central Lab, Reading center, Images, ...)
All studies are performed in compliance with FDA and CDISC requirements. To reach this target, the database structure will be transformed in SDTM structure associated with the appropriate documentation.
Our SDTM/ADaM experts have the ability and experience in developing eCRF's to CDASH standards and delivering data in STDM and ADaM standards.
- Defining XML
- Designing company specific CDISC Standards
- Extensive ODM-XML knowledge
- Therapeutic areas knowledge
- Extensive experience in CDISC SDTM and ADaM conversions and standards: