Many drug development programs fail because of poorly designed clinical studies. The smart use of advanced biostatistics can help you make better informed decisions throughout the life of your program. Certara’s global team of biostatisticians have more than 100 years of combined experience.

We can support you from phase I to IV. Our expertise culminates from a deep understanding of regulatory guidances. Consequently, we support post-approval regulatory commitments, regulatory responses for statistical questions, regulatory briefing book preparation, and face-to-face regulatory meetings. In addition, the team has extensive experience with medical experts as well as key opinion leaders for publication support. By working with Certara biostatisticians, you can help ensure that your clinical trials are conducted in most efficient and cost-effective way.

Data Management

Data management oversight services include:

  • Manage vendor used for electronic case report form (eCRF) build and data management
  • Contribute to eCRF design & development
  • Perform User Acceptance Testing to ensure that the Electronic Data Capture (EDC) system fulfills the requirements for a clinical study
  • Review of data management documents, e.g., Data Management Plan, Data Validation Manual, eCRF completion guidelines, edit check specifications
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Data Management
Statistical Programming

Statistical Programming

Our highly experienced statistical programming team has supported all phases of drug development and provides the following services:

  • Data Transfer from all parties: Sponsor, CROs, central labs, etc.
  • SDTM Dataset programming
  • ADaM Dataset programming
  • TLF programming
  • Review of data for consistency and scientific integrity
  • Support for DSMB/DMC outputs
  • Submission-ready data delivery including SDTM & ADaM Define.XML, Reviewers’ Guides and Pinnacle 21E checks
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Statistical Support

Our highly experienced team of biostatisticians have extensive experience supporting all phases of drug development including:

  • Study design including power and sample size calculations, as well as the statistical section of protocol
  • Development of Statistical Analysis Plan (SAP) and TLF shells
  • Interim analysis planning
  • Analytical reporting
  • Clinical Study Report authoring & review
  • DSMB/DMC participation
    • Development of Stopping Rules
    • Voting statistical board member
    • Independent reporting statistician
    • Charter development/authoring
    • Unblinded DMC team independent of blinded study team
  • Regulatory support including
    • ISS/ISE and submission consulting
    • FDA advisory committee panel support
    • Statistical representation for FDA or global regulatory meetings including briefing books
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Statistical Support
Our Experts
Tom Peppard
Tom Peppard Senior Director

Tom has worked in drug development for 25 years as a statistician and statistical programmer, developing and evaluating clinical trial designs and writing and executing statistical analysis plans. Presently, he works with a global health funding organization to maximize the benefits of their philanthropic activities by helping teams to make data-driven investment decisions to maximize the informativeness of clinical trials through innovative and efficient trial designs.

In his current and previous roles Tom has provided statistical consulting, sample size calculations, study design/simulations and study analyses to pharmaceutical and biotechnology clients. He has collaborated on the formulation of clinical development plans, including: review of literature to determine effect sizes required for approval and commercialization; review of health authority approval documents to devise strategies for endpoints; and evaluation of operating characteristics for interim analysis and program-level decision criteria.

Prior to joining Certara Tom served as the Data Science and IT lead for a consulting company that he founded with several former colleagues. In this role, Tom worked with external providers to solve technical problems, developed a file security model that met business needs and prioritized hardware/software investments. He was responsible for maintaining the company’s statistical programming environment in a qualified state, consistent with 21 CFR Part 11 requirements, including the validation of additions and changes to the environment. He developed corporate SOPs for the QC of statistical analyses, the validation of system-level code, the maintenance of the computer network and the plan for business continuity/disaster recovery.

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