Services for Pharmaceutical and Biotech Companies
At DNM Data Solution, we provide comprehensive clinical data services tailored to the needs of pharmaceutical and biotech companies. From protocol planning to submission support, our expertise ensures accuracy, compliance, and efficiency at every stage of the clinical trial process.
Clinical Data Programming
- Development and validation of SDTM and ADaM datasets
- TLF programming (Tables, Listings, Figures) for clinical study reports
- Ensuring adherence to CDISC standards and submission readiness
Resourcing & Recruitment
Statistical Planning & Analysis
- Flexible staffing solutions for clinical programmers and biostatisticians
- Project-based, contract, and full-time placements
- Talent matched based on domain expertise and real-world project experience
- Statistical Analysis Plan (SAP) development
- PK/PD analysis and modeling support
- Interim and DMC analysis setup and execution
Regulatory & Submission Support
- Preparation of submission-ready datasets and outputs
- FDA submission support aligned with regulatory expectations
- Quality control for consistency, accuracy, and traceability