Medical Writing
Passion for new science and medicine combined with the joy of writing
METRONOMIA, your choice for Medical Writing when:
- You require highly skilled Medical Writers with an MSc/PhD in life sciences who can expertly drive your documents from start to submission readiness, for all stages of clinical drug development
- The need for high-quality clinical and regulatory documentation delivered in a timely manner
- Your documents and communications are subjected to rigorous quality control to ensure compliance with applicable standards and guidelines
- A collaborative partnership – our experienced Medical Writers closely collaborate with your Teams and within Metronomia so that documents benefit from a wealth of experience
- The need to access up-to-date regulatory guidance and insights
- Documents are diligently prepared for the intended target audience; patients, the general public, the scientific community or regulators.
Do not miss the chance to achieve the maximum potential of your information and data through our expert writers. We would be pleased to assist you in the standardization and harmonization of your scientific writing, from one project to an entire clinical development program or portfolio.
Medical Writing services include:
- Clinical Study Protocols (CSP)
- Clinical Investigation Plans (CIP)
- Clinical Study Reports (CSR)
- Clinical Evaluation Reports (CER)
- Investigator Brochures (IB)
- Post Market Clinical Follow-up (PMCF) plans
- Observational Plans
- Statistical Analysis Reports
- Annual Reports/DSURs/PBRERs
- Patient Safety Narratives
- Dossiers, Integrated Summaries of Safety (ISS) and of Efficacy (ISE)
- CTD Module 2 documents for Initial New Drug Applications (INDs), Marketing Authorization Applications (MAA), and New Drug Applications (NDAs)
- Patient information
- Plain Language Summaries (Lay Person): Clinical Trial Results, Informed Consent, Clinical Trial Synopses
- Scientific Publications
- Non-clinical Medical Writing, read more
“We are proud to have such broad scientific and clinical experience in our medical writing team, ranging from pre-clinical and clinical development to preparation of peer-reviewed journal articles. It is great fun to work in close contact with the masters of biostatistics, statistical programming and clinical data management! Just contact us to see what we are made of!”