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. We offer documents in English for global review in addition to documents in Japanese.

Standard Operating Procedure

Detailed view of process

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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 and Details

GCP

We prepare the following draft documents:

  • Clinical Study Report
  • CTD (Common Technical Document)
  • Research papers on clinical study results
  • Protocols
  • Supporting materials for informed consent
  • Investigator’s brochure

PMS

We prepare the following draft documents:

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

Cloud System “crossnote” Medical Writing Support Service

A comprehensive medical writing service based on 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 & operation

Flow of the MW Support Service

flowchart

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Assumed target document

Periodic Safety Reports (RMP compliance version), Reexamination Application data, periodic reports of unknown/non-serious ADR/infection, annual report (including DSUR), Periodic Infection Reports

Service Features

Point 1.
Use of a template, and a streamlined operation by a high-level documentation/review/document management function
Point 2.
Such functions and information required for MW as writing, review, and document management are all put together in one system
Point 3.
Because of the standardization of operational flow, products, and import forms, a certain level of quality is guaranteed even when the target drug or the person in charge changes,.

Functions of “crossnote”

Documentation function

  • Template based document writing
  • XML structured document
  • Simultaneous editing/simultaneous review
  • Assurance of consistency among documents

Document management function

  • Most recent version, one-stop management
  • Version management/comparison of documents
  • High-speed full-text search

Others

  • Advantage of an application type system
  • Industry-reliable package system
  • Document management function

crossnote® is the registered trademark of update it, Inc. crossnote cloud service is a service provided by ShareSite Inc.

ADDIN EX

Our EDC System provides speed,low cost and high quality

For more details

For further information onINTAGE Healthcare Inc., click here:

If you have any questions or comments, please do not hesitate to contact us.

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