Our Core offerings
SDTM & ADaM Development
Regulatory Submission Support
SDTM & ADaM Development
- Full CDISC-compliant programming
- Custom ADaM datasets, metadata, define.xml, traceability
- Pinnacle 21 validation
TLF Generation
Regulatory Submission Support
SDTM & ADaM Development
- Clinical efficacy and safety reporting
- Tables, Listings, and Figures creation
- Custom visualizations (ggplot2, rtables, gtsummary)
Regulatory Submission Support
Regulatory Submission Support
Regulatory Submission Support
- FDA/EMA submission packages
- Define.xml, SDRG, ADRG, ISS/ISE programming
R Programming Solutions
Quality Control & Validation
Quality Control & Validation
- TLF and ADaM programming with tidyverse, admiral, rtables, metatools, ggplot2 with wide use of packages from Pharmaverse.
- Shiny apps, R Markdown automation, interactive dashboards.
- Performing independent validation programming using R.
- Building internal R capability through training and cross-skilling.
- Using open-source tools from the Pharmaverse community.
Quality Control & Validation
Quality Control & Validation
Quality Control & Validation
- Independent QC with double programming (SAS & R).
- Automated unit testing, audit readiness.
Flexible Resourcing
Quality Control & Validation
Flexible Resourcing
- Contract programmers (2–15 years’ experience).
- Dedicated project teams (FSP).
- Long-term partnership models.