Clinical Study Reports and Manuscripts


To augment our biostatistical services, we prepare clinical research reports and manuscripts. Our complete study documentation includes the research report with summary tables and graphics, clinical data listings and computer output of statistical analyses.

Our corporate SOPs and training programs are designed to ensure that the representation and interpretation of study results are consistent with the Protocol, Statistical Analysis Plan and study data. Our scientific and medical writers are committed to ensuring the clarity and accuracy of all reports and manuscripts.

The following is a list of clinical research report and manuscript writing services we offer:

• Clinical Research Reports:
 - Statistical Reports
 - Integrated Clinical Study Reports (ICH template, as per FDA's CTD)
• Safety/Data monitoring reports
• Interim efficacy reports
• Reports on post-hoc/exploratory analyses
• Integrated Summary of Safety and Efficacy Reports.
• Abstracts and Manuscripts:

 - Medical writing
 - Editing for publication
 - Graphics and visuals

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