Excelya’s 30+ Medical Writers average over 10 years of experience to make sure your documents meet the highest quality standards in record time. We leverage that experience to produce documents at every stage of the clinical research protocol lifecycle, from development and submission to publication.
Located in France and Greece, our team of PhD and Master’s level writers have contributed to over 100 peer-reviewed papers in high impact journals.
Our Medical Writers can help prepare a wide range of clinical regulatory documents across the research lifecycle, from study initiation to publication.
Study development and submission:
Documents are written according to ICH recommendations and reporting guidelines for health research.
Our three-pronged methodology for quality control leverages our peer review process:
In addition to the writing activities, I was asked to prepare the future regulatory submission in the context of the European Medicines Agency (EMA Policy/0070) guidance related to the publication of clinical data for medicinal products for human use.
This mission was very rewarding and required rapid adaptation with a deep dive into the regulatory environment and therapeutic area of the product