A top 5 pharma company was conducting an EMA-mandated post-authorization safety study for a hematology asset

As part of the final report, the EMA required a systematic literature review to evaluate the incidence of specific adverse events

Used PICOTS framework and protocol to clearly define the research question and methodology

Conducted a comprehensive search followed by systematic screening and data extraction by dual independent reviewers

Critically assessed risk of bias and quality of included studies

Analyzed relationships between studies, exploring patterns and investigating heterogeneity

Systematically presented extracted data, facilitating comparison and interpretation of findings across research designs and contexts 

Followed PRISMA guidelines to ensure transparency and completeness in the review and writing process

SLR submitted to the EMA as part of a broader post-authorization safety study; client evaluating full publication and poster to highlight results