Clinical Trials
Statistical Excellence

A pharmaceutical company required robust statistical analysis and regulatory compliance across multiple jurisdictions to facilitate entering new markets. They needed expertise in trial design, analysis and approval processes to be compliant with both FDA and European regulatory frameworks.

• Develop comprehensive statistical analysis plan consistent with existing IRB

• Use pilot data to carry out an interim analysis

• Adapt the design if required to achieve a sufficient sample size

1. Trial Design Optimisation

• Adaptive trial methodology development

• Power calculations and sample size determination

• Protocol development and refinement

• Data quality assessment

2. Statistical Implementation

• Statistical Analysis Plan (SAP) development

• Interim quantitative analysis of efficacy and sample size

• 50% reduction in preliminary analysis time

• Qualitative Benefits

• Streamlined pathway to approval

• Enhanced data quality

• Timely intervention for data collection issues in the early stages

• Accelerated market access

• Robust regulatory compliance

"UMBIZO's statistical expertise and regulatory knowledge proved invaluable for our multinational trials. Their adaptive trial designs and analysis capabilities significantly reduced our time to market."

Clinical Research Director

• Statistical Analysis Plan: 1 month

• Pilot analysis and interim report: 3 weeks

• Ongoing preparations for longitudinal data and final SAR

Expanding our adaptive trial methodologies and developing automated statistical analysis tools for complex trial designs.