Data Standards Implementation – SDTM
Comprehensive SDTM Standards Implementation Services
Data standardization into SDTM Standards improves the overall quality of data and efficiency review by regulatory authorities.
AS CDISC REGISTERED SOLUTIONS PROVIDER WE PROVIDE PROFESSIONAL EXPERTISE FOR THE CONVERSION OF CLINICAL DATA TO CDISC SDTM STANDARDS.
IDDI MAKES SURE YOUR DATA ARE READY FOR SUBMISSION.
- All pivotal studies conducted by IDDI are performed with FDA electronic submission requirements in mind. To reach this goal, IDDI transforms the database structure into an SDTM structure associated with the appropriate documentation.
- Our SDTM experts have the ability and experience in developing eCRFs to CDASH standards and delivering data in SDTM format.
- SDTM datasets are generated using the latest CDISC model in production at the start of the process.
- IDDI has the experience and capabilities of performing quality control/verification of existing packages to ensure they are ready for submission
- Our EDC is compliant with ODM standards
SDTM Standards Package
- Mapping to SDTM standards
- SDTM Annotated CRFs
- .xpt file generation
- xml and define.pdf file creation from SDTM dataset definitions
- Validation of data and define.xml files
- Creation of clinical data reviewer’s guide (cSDRG)
- SDTM format allows pooling of clinical trials for Integrated Summaries of Safety & Efficacy (ISS/ISE)
READ OUR CASE STUDY
SITUATION: ONE STUDY, TWO SPONSORS, MULTIPLE SYSTEMS
This collaborative study is run by two cooperative groups, with financial support from a multinational healthcare company. The study protocol was slightly different for each Sponsor.
Due to the collaborative nature of the trial, the study set-up incorporates two electronic data capture (EDC) systems and three different Interactive Response Technology (IRT) systems (two for randomization and one for drug supply).