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Data Management Services
Data Management Unit plays a vital role in the data interpretation part of the bioequivalence/bioavailability studies. It is a critical process which leads to generating high quality, reliable, and statistically sound data from studies, which in turn drive decision making on the assessment of bioavailability/bioequivalence of the drug.
Our data management unit comprises skilled pharmacists and medical experts who work collaboratively to ensure data collection, integration, interpretation, and analysis are accurate, clear, and secure, which align with EMA and FDA requirements which are consistent with the ICH-GCP principles.
1.
Study design, sample size, and power calculation.
3.
Preparation of Integrated Study Report/ Abbreviated Study Report.
5.
Pharmacokinetics and statistical analysis using Phoenix® WinNonlin® and SAS®.
7.
Tabulation, graphical plotting, analysis, and interpretation of study data.
2.
Bioequivalence study protocol write-up with its appendices, including ICF.
4.
Design of CRF as per protocol requirement.
6.
Non-compartmental pharmacokinetics calculation and data plotting.