Biostatistics
The PPD™ clinical research business of Thermo Fisher Scientific’s global biostatistics and programming team offers more than statistical analyses. We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance that:
- Accelerates decision making
- Reduces risk of compromised timelines and errors
- Ensures consistency and quality of global deliverables
- Optimizes efficiencies with robust processes and global infrastructure
Comprehensive experience, tailored biostatistics services
Our comprehensive clinical biostatistics services can be tailored to meet the needs of your project:
- Clinical development planning, study design, analysis and endpoint strategies, as well as supporting methodologies and statistical analysis plans
- Randomization schedule creation and integration with investigational product management, interactive response technology (IRT) systems, as well as other project planning needs
- Scientifically sound interpretation and reporting of results with efficient, quality production of full-output deliverables
- Real-time analysis presentations and frequent, automated and secure web postings
- Statistical consulting, design and operation of adaptive design studies for all phases of trials, from initial dose titration through post-approval services
- Our biostatistics team has been engaged with International Conference on Harmonisation (ICH E9 (R1) since the draft guidance was released and is leading a cross-functional working group to ensure full compliance at every stage
Complete, concise biostatistics reporting
Based on a well-developed plan, the statistical analysis implementation provides customers with timely, high-quality deliverables. We ensure complete, concise reporting through:
- A centralized computing platform that unifies global biostatisticians and programmers, increasing productivity, saving time and enhancing data security
- Analysis strategies that are ICH-compliant
- Production of audit-ready tables, listings and figures
- New drug application (NDA) submission-ready data delivery in Clinical Data Interchange Standards Consortium (CDISC) format
- Integrated submissions of statistical sections
- Data and safety monitoring board (DSMB) output, interim analysis and investigational new drug (IND) safety updates
- Development of comprehensive methods reports describing planned and exploratory analyses
- Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results
- Support for manuscripts and abstracts
Expert statistical analysis
Our global biostatistics team has a broad range of therapeutic experience, and our statisticians hold advanced degrees. We add value to client projects with data-driven information, analysis, interpretation and study design.
