Clinical Biostatistics Services

PPD’s clinical biostatistics team offers more services than statistical analyses for phase II-IIIb trials. It brings an understanding of the science of disease and compounds as well as provides valuable upfront study design and planning assistance. Clients benefit from comprehensive planning because it reduces the risk of compromised study timelines and errors. Our expert biostatistics teams design, analyze and report clinical studies across a broad range of therapeutic areas and are supported by robust processes and global infrastructure.

Quality Deliverables, Global Standards

Located across several North American and European sites, the clinical biostatistics team is experienced in all phases of global clinical trials, facilitating worldwide consistency of standards and quality. Our working practices include:

• Programming based on written specifications
• Independent quality validation of formal deliverables to verify accuracy and audit readiness
• Senior statistical review of all statistical deliverables, from protocol writing through regulatory submissions

Comprehensive Analysis Plans

Concise, accurate reporting of clinical study results begins with development of clear protocols and user-friendly case report forms. 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

Complete, Concise Biostatistics Reporting

Based on a well-developed plan, statistical analysis implementation provides sponsors with timely, high-quality deliverables. We ensure complete, concise biostatistics reporting through:

• 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

Client-Focused Biostatistic Teams

Our biostatistics teams are focused on sponsor needs, timelines and client-specific analysis standards. We have the flexibility to support aggressive timelines, project priorities and various business models, and work closely with the client, facilitating collaborative, proactive communication.

Expert Statistical Scientists

PPD's global biostatistics team has a broad range of therapeutic experience, and statisticians hold advanced degrees. All of our statisticians and statistical programmers receive ongoing, intensive training that incorporates:

• Industry information such as 21 CFR Part 11
• GCP and ICH standards
• SASsoftware programming skills
• Statistical methodology

Team members are also current with industry standards and market trends, such as Clinical Data Interchange Standards Consortium (CDISC) models. Our biostatistics data are formatted to CDISC standards for consistent reporting to clients and regulatory authorities.

Comprehensive Experience, Tailored Biostatistics Services

PPD's extensive biostatistics services can be tailored to meet the needs of your project:

• Program development plans, individual study design, and formulation of analysis strategies and supporting methodologies consistent with ICH guidelines
• Detailed statistical analysis plans, according to sponsor's specifications and approval
• Randomization schedules created and managed to ensure integrity of treatment masking
• Scientifically-sound interpretation and reporting of results, and efficient production of analysis summaries
• Continuing scientific collaboration on ad hoc analyses, regulatory interactions, applications (IND, CTX, IDE) and annual safety reports
• Regulatory submissions (NDA, MAA, BLA, PMA)
• Interim analyses and data safety monitoring boards (DSMBs)
• Real-time analysis, frequent automated production and secure Web posting of treatment-masked analysis summaries
• Statistical support of adaptive designs
• Analysis of epidemiological endpoints, patient reported outcomes and econometric measures/reimbursement strategies