Ergomed’s medical writing team will be with you for the duration of your clinical trial.

 

An interconnected team, every member of the medical writing team has a backup for every project enabling us to work as a seamless unit, offering full backup support.

We offer the full range of study documents including clinical study reports, protocols, investigator brochures, dossiers for IND and IMPD, informed consent and child asset forms and briefing books.

Before your study starts, the Ergomed medical writing team will write, review and quality check all documents while our protocol optimization service coordinates the internal and external experts to design the study and write your protocol. As well as assisting with briefing books, we can also write or update your investigator brochure, assist with compiling your IMPD or convert your IND to an IMPD.

During your study, our team is on hand to amend your protocol in the shortest time possible as well as update ICFs or other documents. Our medical writing experts can also support activities when sponsors are ready to start sharing information on the progress of the study.

At the end of the study, our streamlined processes mean we deliver the clinical study report as quickly as possible after the final results. We continue to support until the completion of the appendices documents and publishing of the CSR to eCTD compliant standards.