Medical Writing is a core established function at ESTERN Medical. Our medical writing team is fully integrated with the design of R&D clinical writing, medical monitoring, pharmacovigilance and biostatistics.
The input of our senior research clinicians, statisticians, and lab scientists ensures that our client’s key messages are medically and scientifically sound and acceptable to the clinician and researchers.
Our group skillfully handles writing clinical projects related to pharmaceutical, biologics, and medical devices development.
ESTERN writers have experience with broad complex medical research topics.
Our documents undergo rigorous quality assurance review before delivery to our client’s review.
Our Medical Writing Projects include:
- Clinical Study Reports
- Protocols (INDs, NDAs, PMAs, 510Ks, IDEs)
- Investigator’s Brochures
- Nonclinical Study Summaries
- Briefing Documents
- Informed Consent Documents
- Adult & Pediatric Assent Forms
- Annual Reports
- Periodic Safety Update Reports (PSURs)
- Integrated Summaries of Safety and Efficacy (ISS/ISEs)
- Literature Reviews
- White Papers/Journal Article