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.
- 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)
- 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.
- Through contracting with physicians who are knowledgeable in safety information and MedDRA, we are able to provide MedDRA coding consultation.
- 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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