Supporting Your Regulatory Needs

We provide medical writing support for every stage in product development, from protocols, informed consent forms (ICF), and investigator brochures (IB) to clinical study reports (CSR). CMIC’s medical writers have backgrounds in preparing various clinical study documents, common technical documents (CTD), and regulatory dossiers. When you need clinical study documents, New Drug Application (NDA) dossiers (including gap analyses on overseas NDA dossiers), and Periodic Safety Reports, we can provide the support you need. Our medical writing services are available in Japan, South Korea, Singapore, Taiwan, Malaysia, Hong Kong, the Philippines, China, Vietnam, Thailand, Indonesia, Australia and New Zealand.

Our Edge in Medical Writing

Largest medical writing group in CRO industry in Japan

  • Comprehensive services for preparation of clinical study documents
  • Capable of synchronous preparation of CSRs and CTD.
  • Optimal proposals are offered by fully experienced medical writers.

We are experienced in supporting overseas customers

  • Our Medical Writing team can prepare clinical study documents as an In-Country Clinical Caretaker (ICCC), conduct gap analyses on overseas NDA dossiers, and support CTD preparation for NDA in Japan.
  • Strong expertise in ICH E3* and M4**

 [Footnote:] * International Conference of Harmonization Structure of Content of Clinical Study Reports (ICH E3). ** International Conference of Harmonization Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (ICH M4).

Services

  • Development and translation of clinical study documents
    • Protocol
    • Investigator Brochure (IB)
    • Informed Consent Form (ICF) and supplementary materials for subjects
    • Clinical Study Report (CSR)
    • PMDA consultation
  • New Drug Application support
    • Support for pre-NDA consultation including document preparation
    • Preparation of NDA dossiers (CTD)

Other Tailored Services

  • Support for post-JNDA inquiries/responses
  • Masking for CTD, review report
  • Documentation aligned with client’s SOP and style guide
  • English documentation for review by clients’ overseas affiliate
  • Standalone QC services on documents prepared by clients
  • Editing checks for all documents

Consulting Services

Regulatory Consulting

Project Management

Clinical Operations

Data Management

Statistical Analysis

Quality Assurance

Pharmacovigilance