Local Product Development in Japan Services related to clinical studies for product registration in Japan

Local Product Development in Japan

Since its establishment as a regulatory consultancy in 1999, Cobridge has provided services related to clinical studies of pharmaceuticals, medical devices, and quasi-drugs and new excipients originating overseas as well as in Japan.

Cobridge prepare documents necessary for conducting clinical study in addition to attending PMDA meetings with our clients, selecting investigators and institutions for clinical studies, and supporting coordination for conducting clinical studies.

Registrations of pharmaceuticals and medical devices in Japan are increasing mainly relying upon foreign clinical data to reduce cost and time to obtain approvals. In order to use foreign clinical data for applications in Japan, foreign manufacturers must verify that the clinical study conducted in a foreign country complies with current Japanese GCPs. Conducting manual and logical data checks to verify the quality of clinical data, and preparing a clinical study report need expertise and experience.

Cobridge has supported a number of product registrations using foreign clinical data over the years since company establishment.  In addition to preparing application dossiers and addressing health authority queries, Cobridge provides comprehensive consultation, such as gap analysis, whether a clinical study conducted outside Japan is usable for a Japanese product application.

Services provided by Cobridge

Preparation of GCP SOPs

In consideration of the client’s business conditions, we provide services for preparation and revision of an international firm’s local office’s GCP SOPs to meet the standards of current Japanese GCPs.

Supporting and preparation of documents for clinical studies

Cobridge provides following services related to planning and conducting clinical studies in Japan

  1. Study design
  2. Sample size calculation (including reviewing literature)
  3. Protocol preparation
  4. CRF preparation
  5. Preparation of investigators’ brochure for both pharmaceuticals and medical devices
  6. Drafting of informed consent documents
  7. Preparation of Clinical Study Notifications
  8. Supporting selecting institutions and investigators

Assisting in meetings with the Japanese health authorities (PMDA)

  1. Preparation of briefing documents
  2. Arrangement of the meeting
  3. Attending the meeting with the client and addressing queries

Leveraging foreign clinical data for Japanese registrations

  1. Consultation for preparing protocol for foreign clinical study and clinical study report
  2. Gap analysis whether a clinical study conducted outside Japan is usable for a Japanese product application, Verification of compliance with Japanese GCPs
    • Preparation of GCP compliance check lists (required documentation for institutions, physicians, IRBs, trial agreements, investigational product, accountability, monitoring)
    • Assessment of trial agreements
    • Verification of data consistency and of fidelity to paper CRFs
    • Consistency of clinical data and study statistics
  3. Preparation of patient listings (both English and Japanese are available)
  4. Data analysis and preparation of clinical study report

Data Management and Analysis

  1. Designing and preparation of database (including preparation of data input screens)
  2. Preparation of protocol for statistical analysis
  3. Conducting statistical analysis
  4. Preparation of analysis summary, figures and tables
  5. Consultation for statistical analysis
  6. Preparation of patient listings

Medical Writing

  1. Preparation of Japanese and English study reports
  2. Preparation of the clinical modules of CTDs
  3. Preparation of manuscript drafts
  4. Comprehensive clinical study services

Addressing clinical-related queries from health authorities after submission

  1. Consultation for strategy to address queries
  2. Preparation of draft response to queries
  3. Proposal and conduct of additional statistical analysis
  4. Literature survey, obtaining necessary literature, and preparation of literature summary
  5. Attending meetings with the Japanese health authority

Support for GCP “Compliance Review”

  1. Preparation of documents for GCP Compliance Review meetings
  2. Assisting with and addressing of queries from the Japanese health authority
  3. Attending GCP Compliance Review meetings

Support for Good Post-marketing Surveillance Practice (GPSP) & Re-evaluation application

  1. Data management
  2. Data analysis and preparation of annual survey report
  3. Preparation of Re-evaluation report