Biostatistics and Data Management

CPC's biostatistical team bring to the project an understanding and knowledge of the disease area and the regulatory requirements for clinical development. This allows them to get involved upfront in the planning and design of the study. The involvement of the biostatistician through the entire study from the design, data collection and cleaning, analysis and reporting reduces risk, improves quality, shortens timelines and lowers costs.

The biostatistician collaborates with the sponsor to develop a comprehensive, well defined ICH compliant statistical analysis plan including:

• Testable and scientifically relevant hypotheses
• Clearly stated sample size justification and powering assumptions
• Statistical conventions and analysis definitions
• Comprehensive description of the statistical methodology
• Mock tables, listings and figures

CPC's biostatisticians bring to your project both industry and academic experience in a wide array of therapeutic areas.

Our Services Include:

• Clinical or product development plans
• Protocol and case report form development
• Statistical analysis plans and statistical programming
• Randomization schedules and treatment allocation plans
• Collaboration on reporting needs (ad hoc analysis, application support and safety reporting)
• Interim and final analyses
• Statistical support throughout your trial or clinical development
• Statistical interpretation and reporting for study reports, manuscripts and presentations
• Data integration
• Independent Committee management, support and reporting (data monitoring, steering and adjudication committees)
• Pharmacokinetic/Pharmacodynamic modeling

Pharmacokinetic/Pharmacodynamic modeling

• Developing PK/PD strategy as part of the drug development plan
• Sample size and power calculation
• Preparation of analysis plans
• Compartmental and non-compartmental pharmacokinetic analysis
• Assessment of PK/PD relationship
• Assessments of Bioequivalence/Bioavailability
• Preparation of analysis plans
• Pharmacodynamic analysis
• Sparse sampling analysis
• Bioequivalence analysis (individual and population)
• PK/PD modeling and simulation
• Tabulation, graphical display, analysis and interpretation of study data
• Preparation of stand-alone or summary reports

Data Management

CPC has data management expertise in all phases of clinical development (Phase I-IV) across a wide array of therapeutic areas.

The results of your trial depend on the quality and integrity of the data. CPC has established standards and procedures that are flexible enough to meet your project needs while ensuring the highest quality of your data throughout the entire study.

Our Services Include:

• EDC design and management
• Study setup and design for paper-based trials
• CRF design
• Data tracking, entry and verification
• Data edit specification, validation and query resolution
• Data integrity and reconciliation with external data sources
• Adverse event and concomitant medication coding