Statistical Programming Services
Regulatory Submission & CDISC Compliance
- CDISC Submission Package Creation:
- Annotated CRFs (aCRF)
- Specifications for SEND, SDTM, and ADaM
- Development & validation of SEND, SDTM, ADaM datasets
- CRT Package Components:
- Define.XML
- nSDRG, cSDRG and ADRG
- Regulatory validation and compliance checks
- CDISC Submission Package Creation:
Legacy Data Handling
- Conversion of Legacy Data into CDISC-compliant formats:
- SDTM & ADaM
- Conversion of Legacy Data into CDISC-compliant formats:
Statistical Outputs
We offer full-service statistical programming support from protocol to submission:
- Tables, Listings, and Figures (TLFs)
- Interim Analysis & support for Data Safety Monitoring Boards (DSMBs)
- DSURs, PBRER, DMC reports, BIMO listings, Patient Profiles
- PK Merge Files, Programmable Protocol Deviations, RTQs
- Customized Reports/Datasets
- Pharmacodynamic (PD) Listings and Analysis
Specialized Reporting Services
Deep expertise in complex statistical and regulatory analysis:
- Safety Reports & Listings (per MedDRA and WHO-DD standards)
- Integrated Summaries:
- ISS (Integrated Summary of Safety)
- ISE (Integrated Summary of Efficacy)
- PK/PD Studies
- Bioequivalence (BE) and Bioavailability (BA) studies
- Observational Studies and Other
