Biostatistics

Obtain timely delivery of high-quality biostatistics with PPD’s comprehensive statistical services. Our expert statisticians design, analyze and report clinical studies across a broad range of therapeutic areas (including medical device) and are supported by robust processes and a global infrastructure.

Quality Deliverables, Global Standards

Located across four North American and three European sites, the 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 deliverables, from protocol writing through regulatory submissions

Comprehensive Analysis Plans

Concise, accurate reporting of 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 Reporting

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

Our 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
SAS software programming skills
Statistical methodology

Team members are also current with industry standards and market trends, such as Clinical Data Interchange Standards Consortium (CDISC) models.

Comprehensive Experience, Tailored 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, including integrated summaries of safety (ISS), efficacy (ISE) and submissions (NDA, MAA, BLA, PMA)
Preparation of regulatory and CDISC compliant electronic case report form tabulations (eCRTs)
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