Summit Analytical’s experienced team provides a wide range of statistical consulting and program level planning services for clients. Our staff are acutely aware of the vital role and added value that an experienced Biostatistician can add to the pharmaceutical, biotechnology, device and biosimilar development process. We have the rare ability to work seamlessly with each project team in order to provide not only quality analyses, but also sound statistical solutions to complex development programs. We provide clients statistical consulting and planning services for the following:

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• Research and planning for target product profiles (TPP) and Clinical Development Plans (CDP)

• Program level statistical methods for endpoints and assessments at each phase of development

• Developing the PK/PD strategy for a drug development program

• Statistical planning to support global regulatory applications (e.g., INDs, NDAs, BLAs, ANDAs, IMPDs, PLAs, PMA, 505 b(2), and 510(k))

• Regulatory Meeting support and statistical representation (e.g., Pre-IND, EOPII, Pre-NDA/BLA, and Type C meetings)

• Regulatory Advisory committee support, preparation, and representation.

• Market Access Statistical Support:

  • EU, NICE Commission, and Government Insurance Payer Panel analysis and reporting

  • US Insurance and Pharmacy and Therapeutic Committee cost/benefit analysis and reporting

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