Maria Fernström

Senior Director, Clinical Project Management and Medical Writing

Maria Fernström is Senior Director, Clinical Project Management and Medical Writing at Cytel. Maria has more than 25 years’ experience in the life sciences industry, which gives her a broad understanding of the drug development process from clinical trial planning and execution in Phase I to Phase IV according to ICH-GCP.

Maria’s team of highly educated medical writers with PhDs has a thorough understanding and ability to evaluate clinical regulatory documents and ensure that the documents are regulatory-compliant and submission-ready. The team has broad experience with indications and different regulatory documents, such as CSP, CSR, narratives, ISS, ISE, and Module 2 and 5 documents.