Biostatistics and Statistical Programming

Biostatistics and statistical programming are two of the core competencies of Everest Clinical Research.

Our Biostatisticians and Statistical Programmers offer years of industry experience, therapeutic knowledge, and familiarity with regulatory requirements to assist you with a full range of biostatistical and programming services.

  1. Drug development program design, study design, protocol development, sample size calculation, statistical analysis planning, subject randomization, data analysis and reports generation for clinical studies of all phases (phase I-IV, retrospective observational studies, and patient registries).
  2. Data integration (e.g. ISS, ISE), data conversion from legacy datasets to CDISC compliant datasets. Assembling and performing QC on datasets, statistical tables, listings, and figures, study reports, etc. for regulatory submissions.
  3. Statistical analysis of study data in support of the development of investigator brochures, integrated summaries, post-marketing safety surveillance reports, abstracts, manuscripts, presentations and posters.
  4. Exploratory data analysis of completed studies for publications, signal detection, planning and designing of new studies. These include analyses of data from combined studies and individual studies, post-hoc analyses.
  5. Statistical analysis and programming support for DMC/DSMB activities, or unblinded data analyses for interim assessment of ongoing studies.
  6. Statistical analysis and programming support for health economics and outcomes research studies, payers and claims databases.
  7. Collaboration with researchers and publication teams to generate publications of study results.
  8. Medical Writers, Biostatisticians, and Medical/Regulatory Reviewers together develop abstracts, manuscripts, publications, presentations, and posters.
  9. Pharmacokinetic and pharmacodynamic data analysis and modeling.
  10. Due diligence activities.
    • Support both parties interested in a partnership/investment and parties interested in obtaining a partner
    • Statistical defense of data and analysis results
    • Statistical evaluation of data and analysis results of drug candidates
  11. Statistical analysis and programming support for medical devices and pre-clinical studies.

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