PPD Functional Service Partnership (FSP) Biostatistics and Programming Solutions
Gain confidence, clarity and focus with biostatistics and science expertise
PPD’s global biostatistics and programming team brings a deep understanding of the science of disease and compounds . To keep pace with innovations in biostatistics, you need expertise that blends scientific and technical knowledge to deliver more effective clinical designs, more detailed data analytics and more accurate data interpretations. Our experts apply experience in all phases of clinical trials, in all parts of the globe and across a broad range of therapeutic areas to deliver the insights that will drive your asset forward.
Our experience enables you to develop and implement a broad range of adaptive trials and innovative design approaches (e.g., platform, basket and umbrella designs) and leverage Bayesian analyses such as continual reassessment method as well as statistical forecasting, simulations, estimands, missing data, interim analysis and more.
Adopting these approaches can help accelerate timelines, reduce costs, and focus development on the most promising agents at the right doses in the right indications for the right patients. We proactively work in collaboration with our clients, as well as across the industry to facilitate collaboration and idea sharing. For example, our cross-functional adaptive design working group has helped to forge the advancement of adaptive designs for over ten years, and our cross-functional estimands working group focuses on optimizing estimands implementation.
Propel quality and compliance with robust technologies, processes and global infrastructure
Collecting and analyzing data is complex. By partnering with the experts at PPD, you gain access to solutions, processes, tools and technologies — both industry standard and proprietary — that drive quality, efficiency and compliance with every deliverable. Some of the systems we employ include:
- Biostatistics Technology Infrastructure (BTI) – proprietary SAS-based computational platform that combines hardware, software, and global processes to provide complete traceability, version control, and speed for project deliverables
- Data Transfer Exchange (DTX) – is a game-changing suite of macros to assist in the creation of study data tabulation model (SDTM) and non-standard transfers through a metadata-driven approach
- Define on Demand (DOD) – The CDISC Define -XML standard represents the industry standard for all eCRTs (electronic Case Report Tabulations)
- Program Builder Tool (RACE-PBT) – uses metadata to create executable SAS Programs that produce outputs and templates sheets to use for future studies to provide cost savings, faster deliverables and high quality
- Preclarus® – proprietary patient data dashboard that provides a dynamic visualization-based view of SDTM data
- FACTS™ – software to model, simulate and execute early-stage adaptive trials
- East® – software to model, simulate and execute later stage adaptive trials
- R – is a programming language for statistical computing and graphics
Keeping pace with the rapid evolution of our industry requires agility. From adopting wearables and data collection devices, to leveraging virtual sites, to applying metadata solutions to our statistical deliverables, we’re prepared to quickly adapt procedures and apply the latest cutting-edge technical solutions to your project.
We’re also leaders in our industry’s knowledge and understanding of global regulatory requirements and take an active role in standards development. PPD supports and contributes in several ways:
- Corporate sponsor of CDISC (Clinical Data Interchange Standards Consortium) since 2000
- Participant in the CDISC advisory board, the submission data standards, and Clinical Data Acquisition Standards Harmonization (CDASH) teams
- Engagement with International Conference on Harmonisation (ICH E9 (R1)) since draft guidance was released to lead a cross-functional estimands working group to ensure compliance
Our global infrastructure also supports client-specific support for country, regional and global deliverables with consistent worldwide standards of quality delivery. 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
Customized solutions to meet your specific needs
Before awards are made, PPD ensures your specific needs and expectations are fully understood, which enables teams to be quickly allocated to meet your precise requirements.
To span all time zones and provide 24-hour coverage to you, we have employees located across the globe – with key locations in North America, Europe, Africa, and Asia Pacific. Crucial client-facing roles are strategically placed in the same time zones as your functional and clinical teams, so our combined team becomes a unified group integrated with your biostatistics function.
Our project teams are designed to plan and execute the study analyses efficiently and with scientific integrity. Each project team is empowered with the flexibility to provide solutions that meet your unique needs and include a customized mix of roles. A typical team may include a lead biostatistician, a senior statistical reviewer, a lead programmer and additional supporting staff.
Biostatistics team members have a broad range of therapeutic experience, most often holding advanced degrees. In collaboration with the client’s assigned clinical and statistical scientists, PPD’s assigned lead biostatistician will create a detailed statistical analysis plan (SAP) for the study.
Dedicated staff managers ensure that all staff assigned to a partnership receive internal PPD training along with specific project and therapeutic training and “just-in-time” training for particular tasks. All our statisticians and statistical programmers also receive ongoing, intensive training that incorporates:
- Industry information such as 21 CFR Part 11
- Good Clinical Practice (GCP) and ICH standards
- SAS® software programming skills
- Statistical methodology including adaptive design
With this proven approach, we collectively create successful teams, encourage knowledge sharing, and produce positive, productive interactions throughout the duration of our partnership.