Medical Writing

Benefits

  • We provide high quality services with our well-experienced medical writers
  • We offer total support with one-stop services. With a combination of writing and regulatory operation support services, we can make efficient and optimal proposals for submission to the authorities
  • We have resources and knowledge to meet your needs and handle urgent requests

Our medical writing services

Preparation of:

  • Clinical protocols
  • Investigator’s Brochures (IBs)
  • Clinical study reports (CSRs)
  • Common technical documents (CTDs)
  • Responses to PMDA queries
  • Development safety update reports (DSURs)
  • Early post-marketing phase vigilance reports
  • Periodic safety reports
  • Periodic benefit-risk evaluation reports (PBRERs)
  • Re-examination application
  • Articles
  • Other documents
  • Document quality control (QC)
  • Document translation

(Available in Japanese and English)

Examples of experiences

Oncology-related:

Preparation of:

  • Documents for Phase I clinical trial (drafting of a protocol, a case report form, an informed consent form, and IB)
  • CSRs for Phase II clinical trial
  • CSRs for Phase III clinical trial
  • CTDs M2.5 and 2.7
  • DSURs
  • Periodic safety reports
  • Articles

Central nervous system-related:

Preparation of:

  • ASEAN CTD M3 and M4
  • Re-examination application
  • PBRERs

Autoimmune disease-related:

Preparation of:

  • Periodic safety reports
  • Re-examination application

We have abundant experiences in various fields.

Process

We will suggest the optimal process for your project to ensure high-quality deliverables.

Example of process


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