Experienced Experts Provide Prompt and Accurate Support

Our experienced experts support collection, evaluation and analysis of safety information ranged from clinical trials, post-marketing clinical studies, post-marketing surveillance (specified drug use investigations, drug use investigations), academic literature investigations and reports development to the Pharmaceuticals and Medical Devices Agency. We also transcribe overseas adverse drug reaction/infection case reports into appropriate format for submission to the authority.

Major Services

  • Primary Assessment of Overseas Information in CIOMS and MedWatch Forms and Translation into Japanese
  • Primary Assessment of Clinical Trial/Post-Marketing Safety Information in Japan and Translation into English
  • English Translation (CIOMS/MedWatch Preparation) Services
  • Support for Instructions to Monitors and MRs
  • Preparation of Research Reports and Adverse Drug Reaction/Infection Case Reports (drafts) from Academic Literature and Submission to the PMDA
  • Preparation of Adverse Drug Reaction/Infection Case Reports, Research Reports, Measure Reports and Defect Reports (drafts) and Submission to the PMDA and Listed into SGML
  • Preparation of Adverse Drug Reaction Reports (Draft) for Overseas Offices and Regulatory Authorities in Various Countries and Translation into English
  • Provision of Consultation for General Pharmacovigilance Activities and Other Related Activities
  • Consultation by Contract Specialist Physicians for Adverse Events
  • Preparation of Various Reports (Preparation of Documents (Drafts) for Company Safety Evaluation Committees, Preparation of Documents (Drafts) for HQ and Overseas Affiliates)

  1. Our staff, having working experience in the safety information management departments of pharmaceutical companies and fluent in English, is able to provide you single support and full support.
  2. Through contracting with physicians who are knowledgeable in safety information and MedDRA, we are able to provide MedDRA coding consultation.
  3. Through our contract specialist physicians, we are able to provide consultation for adverse events which are difficult to assess.

[ Contact ] Sales Department TEL +81-3-5804-7577 / FAX +81-3-5684-7872

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