Clearly defining study objectives and validating study design is essential to project success. The data sets, collection process and interpretation and reporting mechanisms need to be optimized to ensure the statistical accuracy of your trial, whether for traditional designs or emerging strategies. Our statisticians are involved with protocol and clinical program development; and provide input on the eCRF design for best data collection practice.
Our experience translates to expertise in statistical consulting, design and operation of traditional and adaptive design trials for all phases from initial dose titration through post-approval services including:
- Protocol design, analysis and endpoint strategies
- Development and implementation of statistical methodologies
- Statistical Analysis Plan (SAP) development
- Data analysis and reporting
- Medical writing services
- Clinical development planning
- Randomization schedule creation
Based on a well-developed plan, the statistical analysis implementation provides Clients with timely, high-quality deliverables. We ensure complete, concise reporting in CDISC or CDASH through:
- ICH compliant analysis strategies
- Production of audit-ready tables, listings and figures
- Development of comprehensive methods reports describing planned and exploratory analyses
- Collaboration with medical writers and clinical scientists ensuring appropriate interpretation and documentation results
- Support for manuscripts and abstracts
Download our brochure to learn more about how we Innovate and Integrate to Execute your clinical studies.