Celerion is committed to delivering high quality reports within the established timelines facilitated by our team of medical writers with extensive clinical experience and qualifications, including PhDs, public health, nursing and science degrees.
This clinical knowledge is an invaluable component of the skills required to produce a high-quality clinical study report. The medical writing team’s broad background in pharmacology, physiology, therapeutics, and acute and chronic diseases ensures that the medical writer looks beyond the basic safety analysis and considers other factors that may cause or contribute to clinical results. The team works closely with the physicians and principal investigators to ensure reporting accuracy.
To further enhance the scientific input for protocols and reports, Celerion has consolidated the study design/protocol development scientists and medical writers into the same team. This approach has improved the accuracy of data and shortened project timelines.
Comprehensive medical writing and reporting services:
- Generate and verify preferred term coding of adverse events, medical/surgical histories and concomitant medications
- Written interpretation of safety results for ICH-compliant study reports
- eCTD- and ICH E3-compliant clinical study reports