Clinical programming services
Clinical programming services include statistical programming, summary and statistical reports for non-clinical and clinical studies, including:
- Study analysis and reporting
- Prepare statistical analysis plan (SAP)
- Prepare analysis dataset specifications
- Generate analysis datasets and/or ADaM datasets
- SCS/SCE (pooling) database preparation
- SCS/SCE (pooling) statistical analysis
- Tables, Listings and Figures (TLF)
- CDISC SDTM,SEND and ADaM data conversion
- Creation of CDISC documentation ( Reviewer’s guide; Define.xml)
- SAS programming for interim and final analysis
- Interim analysis and DMC Support
- Patient profiles and ad-hoc reports
- PK/PD model development and analysis
- Perform SAS programming verification and validation
- Provide all programming documentation
- Ad hoc or exploratory programming
Clinical Data Interchange Standards Consortium (CDISC) devised the SDTM and ADaM models to standardize data structures for submission of raw and analysis data from clinical trials. These standards are highly desirable by various regulatory authorities worldwide, including US-FDA.
CRC has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider (Gold Member). We have converted more than 100+ studies (ANDA, NDA) as part of regulatory submissions, all of which have been accepted by the FDA.
We have an in house team of expert with strong technical understanding of both Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), corresponding implementation and Reviewers’ guides, CDISC terminologies and the related regulations.