You can depend on our statistical programming and biostatistics team to operate in tandem for top-quality deliverables. Our team of dedicated programmers has years of Statistical Programming expertise, combined with an in-depth understanding of specific clinical subject matter and domain, which ensures meeting timelines with quality.
At ACL Digital, the statistical programming team includes qualified statistical programmers well exposed to studies of varied complexities and scales of data.
Statistical Programming for Clinical Data - Services
- CDISC Implementation – CDASH, SDTMs and ADaMs
- CDISC Conversion of Legacy Data
- QC/ Validation
- TLF generation
- Creating ADaM and TLF Specifications
- Ad-hoc analyses
- In-house Statistical Computing Environment available for Client needs
- Patient Profiles and Narratives generation
- R-programming expertise
- BMI OSI listings
- Generate define.xml
- Pinnacle 21 Report Compliance for Datasets, Authoring Reviewer’s Guide
- Clinical Pharmacology – PK/PD programming including PopPK analyses
- Epidemiology and RWE programming support, Support for Medical Affairs and Commercial requests
- Implementation of DMP (Data Management Plan) and SAP (Statistical Analysis Plan)
- Safety and Efficacy TLFs for CSR, and Regulatory Agencies submissions
- Safety Monitoring, Interim Analysis and DSUR support
- Exploratory analysis
- Integrated Summary of Safety and Efficacy analysis (ISS/ISE), Data Pooling