Clinical Biostatistics Services
PPD’s global biostatistics and programming team offers more than statistical analyses. It brings an understanding of the science of disease and compounds as well as provides 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 Services
PPD's extensive biostatistics services include comprehensive analysis plans that 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 voice response (IVR) and interactive Web response (IWR) 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
Complete, Concise Biostatistics Reporting
Based on a well-developed plan, the statistical analysis implementation provides sponsors with timely, high-quality deliverables. We ensure complete, concise reporting through:
- Biostatistics technology infrastructure (BTI)
- 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 tables, listings and figures, audit-ready at delivery
- 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
PPD's global biostatistics team has a broad range of therapeutic experience, and our statisticians hold advanced degrees. We add value to client projects and support our organization with data- driven information, analysis, interpretation and study design.
Comprehensive Analysis Plans
Reporting of study results begins with development of clear protocols and user-friendly case report forms (CRFs). Our statisticians help with protocol and clinical program development. We assist in CRF design – for best data collection practices – as well as with data monitoring, collection and management methods. From there, our statisticians interact with sponsor scientists to develop a comprehensive statistical analysis plan, including:
- Overview of study objectives, description of study population, sample size rationale and statistical power
- Conventions and definitions for summary and analysis of demographic, baseline, efficacy and safety data
- Detailed description of statistical methodology
- Shells of all planned tables, listings and figures
