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Data Analysis

Comprehensive data service to deliver high-quality data analysis

Analysing data

We have extensive experience supporting studies from the design and planning phase to performing analysis and preparing for study submission or grant application.  â€‹

Optimal Study Design

  • Study design and clinical trial planning 

  • Endpoint development

  • Sample size and power estimation

  • Protocol development

  • Treatment assignment/randomization scheme for participant and investigational medicinal product (IMP)

Data Monitoring

Statistical Analysis

  • Safety review and/or dose escalation 

  • Data Monitoring Committee (DMC) service

  • Integrated safety, efficacy, immunogenicity summary (ISS/ISE/ISM/ISI)

  • Bioresearch monitoring (BIMO) report

  • Statistical analysis plan (SAP)

  • Statistical table, figure, and data listing for clinical study report (CSR)

  • Pharmacokinetic (PK) and pharmacodynamic (PD) analysis

  • Statistical analysis section of a grant application

  • Exploratory analysis and report for publication or presentation​​

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