Data Management Services

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Pharmacokinetic & Statistical Analysis

  • Non-compartmental pharmacokinetic analysis using validated Phoenix® WinNonlin® and Kinetica™ software.
  • Statistical analysis using validated Phoenix® WinNonlin® and SAS®.
  • Sample size and power calculation using SAS® software.
  • Assessments of Bioequivalence/Bioavailability.
  • Tabulation, graphical display, analysis and interpretation of study data.
  • Preparation of stand-alone or summary reports.
  • Data Management & Medical Writing.
  • Study design and development of Protocol and Informed Consent Form (ICF).
  • Designing of Case Report Form (CRF) as per protocol requirements.
  • Preparation of Bioequivalence Report, Clinical Report, Analytical Report and Statistical Report by GLP and GCP principles.