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Safety management

Our delegation is to ensure the safety and reliability of pharmaceutical products,medical devices,quasi-drugs, cosmetics,regenerative medicine products,etc.

We provide services/support for safety management: consultations for safety management prior to conduction of clinical trial, gathering safety information during clinical trial, and management of post-marketing safety information,etc.
Flexible services are provided to short and long term duties in order to satisfy sponsors’ needs.

Our Services

  • Preparing of electronic report (draft) etc., to PMDA.
  • Preparing of notification in writing (draft) to Investigator and head of the study sites.
  • Preparing of periodic report (draft), drug reexamination report (draft) and treatment outcome report (draft).
  • Coding (MedDRA), Database entry, SGML creation, CIOMS writing, adverse event report writing, translation (English ⇔ Japanese)
    *Both for on-site/ off-site
  • Medical evaluation by medical experts (consulting by our contract specialist physician and creation (draft) of written opinion of reporting entity).
  • Quasi-drugs/ cosmetics adverse reaction report.
  • Seminars about newly amended system for reporting adverse reactions of Cosmetics/ Quasi drugs.
  • Preparing of DSUR.