Email: contact@prodatainsight.com
Our Services
We map you clinical data to meet the standards.
CDISC Data Mapping
Compliance with Clinical Data Interchange Standards Consortium (CDISC) standards during clinical trials reduces the time to regulatory submission and enables better communication between team members.
With over 12 years’ experience working with CDISC Standards, our subject matter experts lead the training and implementation of standards around the globe. They are at the forefront of the transformation of the standards working closely with CDISC on Biomedical Concepts. Our team of highly qualified consultants will ensure that your CDISC data is submission ready. We work closely with you as part of your team to implement CDISC standards across the clinical data lifecycle. We deliver high quality data, first time every time.
CDISC FDA Submission Support
PDI’s programmers and statisticians have supported multiple successful FDA submissions. We can produce the ISS, ISE and their associated integrated CDISC databases, together with all submission CDISC deliverables (such as Define.xml and Reviewer’s Guides).
CDISC Training and Advice
We are CDISC authorised trainers in SDTM and ADaM. We advise pharmaceutical companies all the way from first steps of implementing CDISC through to full implementation.
CDISC Conversion
We were founded on our SAS and CDISC expertise and we can provide comprehensive and effective SAS CDISC programming support for CDISC conversion of legacy and ongoing studies. PDI’s programmers and statisticians have converted over 200 studies to CDISC standards.
SDTM
ADaM
SDTM
CDISC is the standard for submitting clinical data to regulatory agencies. As a member of the CDISC organization, PDI keeps its knowledge of SDTM implementation guidelines current. Our SDTM services include
- developing SDTM datasets for ongoing studies
- converting existing databases to SDTM standards.
ProDI utilizes industry standards/references in the creation of SDTM datasets:
- CDISC SDTM Implementation Guide
- CDISC SDTM guidance
- SDTM Controlled Terminology
- Indication-specific SDTM specifications, if applicable
Our processes in SDTM development are as follows:
- Map raw data variables to SDTM domains (identify domains, required, expected, permissible and relationship variables)
- Create annotated CRFs
- Create SDTM specification documents
- Program and validate SDTM domains
- Create Define.xml
- Create Study Reviewer’s Guide
- Produce Submission Package
- Quality Control at each step of the process
ADaM
On the basis of the statistical analysis strategy and the table, list, and figure shells, ProDI creates the specifications for ADaM datasets. The SDTM datasets are the preferred source data for the ADaM datasets, while they can also be made using the original (native) study datasets.
We implement industry standards/references when creating ADaM datasets:
- CDISC ADaM Implementation Guide
- CDISC ADaM OCCDS Guide
- ADaM Controlled Terminology
- Indication-specific ADaM domain specifications, if applicable
Our processes in ADaM development are as follows:
- Map relevant raw or SDTM data variables to ADaM domains
- Determine derived variables for analysis
- Determine analysis flags (population, sub-group, criterion-based) needed for analysis
- Create ADaM specification documents based on the above
- Program ADaM domains
- Validate ADaM domains
- Create Define.xml
- Create Study Reviewer’s Guide
- Produce Submission Package
- Quality Control at each step of the process
Partner with PDI and embark on a transformative journey towards data-driven excellence.