Statistical Excellence for Phytopharmaceutical Market Entry

A leading manufacturer of phytopharmaceuticals sought to enter the German market with their solid dose, plant-based treatment for urinary tract infections. They required comprehensive statistical expertise to develop a robust Phase II trial proposal that would meet strict European regulatory standards while demonstrating efficacy and safety.

• Develop comprehensive statistical action plan for Phase II clinical trial

• Create IRB proposal compliant with German regulatory requirements

• Design appropriate analysis strategy and table shells

• Analyse interim pilot data to inform final trial design

• Ensure statistical robustness for successful market entry

1. Trial Design Optimisation

• Comprehensive literature review of UTI treatments

• Power calculations and sample size determination

• Endpoint selection and validation

• Risk-benefit assessment framework

2. Statistical Implementation

• Statistical Analysis Plan (SAP) development

• Table shells creation for regulatory submission

• Interim analysis methodology

• Adaptive trial design to optimise resource allocation

3. Regulatory Compliance

• IRB proposal development aligned with German requirements

• Documentation for European regulatory frameworks

• Quality control protocols

• Data management strategy

Quantitative Outcomes

• 40% reduction in statistical planning time

• Optimised sample size based on pilot data analysis

• Identification of key efficacy markers

• Enhanced statistical power through refined methodology

Qualitative Benefits

• Streamlined pathway to German market approval

• Enhanced data quality assurance

• Early identification of potential regulatory hurdles

• Robust foundation for future European market expansion

• Scientifically sound approach to natural product validation

"Umbizo's efforts proved invaluable for our Phase II trial planning. Their meticulous approach to the IRB proposal and analysis of our pilot data significantly strengthened our regulatory submission. The team's understanding of phytopharmaceutical research challenges and European regulatory requirements was exceptional."

Head of Clinical Development

• Statistical Action Plan: 3 weeks

• IRB Proposal Development: 1 month

• Pilot Data Analysis: 2 weeks

• Final Documentation: 3 weeks

Expanding the statistical framework to support Phase III trials and developing specialised approaches for plant-based medicines across multiple European markets.