We understand CDISC
Do you need CDISC compliant datasets? At Quotient we understand CDISC, its impact on early Phase studies and its importance to your future regulatory authority submission, which is why we are an established CDISC Gold Member. CDISC is built into our standard data management and statistical procedures; we have delivered hundreds of SDTM and ADaM datasets and we can do the same for you.
- Development of dataset specifications and an aCRF with reference to SDTM and ADaM Implementation Guides.
- Programming of SDTM and ADaM datasets according to specifications, including verification, quality control and validation via an OpenCDISC validator and an electronic check of the dataset structures versus the dataset specifications.
- Provision of metadata files and blankcrf.pdf
- Includes all clinical, pharmacokinetic and scintigraphic data
- Optionally, we can also provide a full define.xml package including: define.pdf, trial design datasets, subject level datasets, traceability documentation and a data reviewers guide in pdf and linked to SDTM define.
Standardising study data with CDISC