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.
- Preparing of electronic report (draft) etc., to regulatory athorities in each region.
- 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.