serviceMedical Writing

Experienced and reliable professionals quickly respond to your project needs in full compliance with regulations and guidelines

With guidance from professional medical writers, our vastly-experienced writing team provides various documents from applications and reexamination applications to preprints of scientific papers, all in compliance with guidelines.

Standard Operating Procedure

プロセスの詳細図

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*1 The number of reviews will be customized depending on the type of report, request, etc.
*2 The final draft is subjected to quality check by a third party.

Service Features

Point 1.: High-quality documents generated by experienced medical writers
Point 2.: Professional level of documents in English on drug development

Main Services with Details

GCP

We prepare the following draft documents:

Clinical study report
CTD (Common Technical Document)
Research papers on clinical study results
Protocol (draft)
Subject informed consent (draft)
Investigator’s brochure

PMS

We prepare the following draft documents:

Periodic safety report
Reexamination applications
Post-marketing study papers
Risk Management Plan (RMP)
Protocol and implementation guidelines
English translation of reports and applications

Cloud System “crossnote” Medical Writing Support Service

A comprehensive medical writing service utilizing cloud-based document writing support/management system

Using the cloud-based comprehensive documentation solution “crossnote,” we provide comprehensive support for effective, integrated and standardized medical writing services from the initial definition of requirements to system development and operation.

“crossnote” is a registered trademark of update it, inc.