Our Expertise in Biostatistics & Clinical Trials

We provide advanced statistical methodologies and analytics platforms to support all phases of clinical research, from trial design to regulatory submissions.

1. Clinical Trial Design & Study Protocol Development

• Statistical guidance for Phase I-IV clinical trials

• Randomisation techniques for unbiased study designs

• Sample size calculation & power analysis to ensure study validity

• Adaptive trial designs for flexibility in clinical research

2. Statistical Analysis & Data Interpretation

• SAS-based data processing & analysis for clinical endpoints

• Descriptive & inferential statistics for trend identification

• Survival analysis & time-to-event modelling

• Bayesian & frequentist methodologies for data validation

3. CDISC-Compliant Data Management

• End-to-end support for CDISC (SDTM & ADaM) standards

• Data cleaning, transformation & standardisation

• Automated submission-ready datasets for regulatory review

• Integration with EDC (Electronic Data Capture) systems

4. Real-Time Monitoring & Risk-Based Analytics

• Interim analysis & adaptive trial monitoring

• Risk-based monitoring (RBM) for early issue detection

• AI-powered anomaly detection & trend forecasting

• Data visualisation dashboards for real-time insights

5. Regulatory Submission Support

• Preparation of clinical study reports (CSR) & statistical summaries

• Compliance with FDA, EMA, ICH-GCP, and other regulatory bodies

• SAS-based TFL (Tables, Listings, and Figures) generation

• Support for New Drug Application (NDA) & Biologics License Application (BLA) submissions