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Study Reporting

The Atlantia Clinical Research team provides a comprehensive study reporting service. Our statisticians adhere to ICH-GCP standards to produce a statistical study report, and if the client requests, a full clinical study report. Atlantia maintains no rights to Intellectual Property generated from this study. Atlantia maintains ownership over its procedures and software, but not the data generated. The study reporting phase or close-out phase includes biostatistics analyses and a clinical study report along with a final presentation:

  • Biostatistics Analysis: The Atlantia team along with several biostatisticians with expertise in a wide range of health areas, are able extract and analyse data from the electronic data capture system. A statistical analysis plan is tailored to the sponsors study to ensure the most accurate analysis of primary, secondary and/or exploratory outcomes is conducted. The Statistician will prepare and finalise the Statistical Analysis Plan (SAP), including mock tables, which will be signed by the sponsor, in advance of database lock. Once the database is locked, the statistician will perform the statistical analysis and provide a draft of the Tables, Figures, Listings (TFLs) for review. The dataset will be available on SPSS, Excel Compatibility or CSV formats. Once approved by the sponsor a final version will be issued.
     
  • Clinical Study Report (CSR): Out Scientific team will prepare a CSR and the draft will be circulated to the sponsor.A final draft will be prepared with comments, corrections and amendments included. The results will be presented in a final study close-out meeting.

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