Regulatory Compliance & Data Strategy
Ensure data integrity and meet stringent global regulatory standards (e.g., FDA 21 CFR Part 11).
Regulatory Compliance & Data Strategy
Where precision meets Strategy
- Service: Consultation on data governance, system validation, and the development of compliant computational frameworks.
- Expertise Applied: Designing systems for audit trails, electronic signatures, and controlled documentation.
- Client Benefit: Mitigated regulatory risk, successful audits, and foundation of trustworthy data.
We provide expert statistical design, modeling, and analysis for health-related research, supporting everything from clinical trials to public health studies.
Applications:
Clinical trial protocols (Phase I–IV)
Epidemiological studies (cohort, case-control, cross-sectional)
Vaccine and drug efficacy evaluations
Observational studies and registries
Benefits:
Optimize trial design with accurate sample size and power calculations
Improve credibility with peer-reviewed statistical methodologies
Gain meaningful health insights from population-level data