PV/PMS Service
Support during development and after manufacturing and sales
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●Taking advantage of our experience in staffing and translation services, we can respond to a wide range of acceptance, evaluations (drafts), report for authorities (drafts) preparation, translations, etc. of ICSRs (individual case safety reports). ●We will respond flexibly according to the purpose and request, such as project support, contracting only necessary work, or dispatching human resources. ●If you have any problems about PV/PMS, we would like to hear from you and help you solve the problem, so please contact us first. |
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■Business Support
◆ICSR (Individual Case Safety Report) Related Services **after clinical trial & marketing
●Input-related: Case acceptance, numbering, database input
●Evaluation (draft) preparation: 0th evaluation, re-assessment instruction (draft) preparation
●Translation: CIOMS (Overseas Case Report) Form (draft) preparation, translation overseas PV/PMS Information/CIOMS Form, etc. into Japanese.
●Report for Authorities (draft) preparation: Side effects and infectious diseases case report (draft), research report and overseas measures report (draft) preparation
◆Translation
●Documents and materials required for PV/PMS
●Literature
●Attachments, etc.
■Consultants or business support
◆Document-related operations
●RMP (Risk Management Plan)
●Various periodic reports
◆Other PV/PMS operations
●Self-inspection, education and training
●Preparation and revision of SOP, manuals, etc.
●Launch of PV/PMS Division/Business Improvement etc.
■Other supports
◆Screening operations of Literature and Academic Society Information
☆Post-marketing surveillance (PMS) support services
◆For PMS contract / registration / progress management, medical institution support (including monitoring), DM / statistical analysis, etc., We will carry out in collaboration with department in charge in our company.
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