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Pharmacovigilance
Our experienced staff members support you
to evaluate and report safety information
at clinical trials and post marketing
intellim's Pharmacovigilance Services
Our experts support you to evaluate adverse events/reactions at clinical trial and post marketing, local and foreign safety information in literatures, report on the safety measures taken in foreign countries and others primarily, and prepare draft reports to PMDA.
In addition, intellim support to translate the safety information into English to prepare draft report to your foreign-based affiliates or partners companies in a timely manner.
intellim also support you risk-management plan, post marketing survey and other planning, its operation and safety reporting, in addition, we can support you to respond to re-examination by PMDA.
Our Services
Primary Evaluation, draft Report to PMDA and Report to foreign Regulatory Authority on local and foreign adverse reactions
Data entry of local and foreign adverse reaction (defect), its primary evaluation: Pharmaceuticals and Medical Devices in clinical trials and post marketing.
Preparation of draft Report to PMDA
Translation and Preparation: local safety information, draft CIOMS form for foreign affiliates and partners
Preparation of various documents (to respond to PMDA, draft materials for Safety Evaluation Committee, and others)
Primary Evaluation, draft Report to PMDA on literatures and information at conferences, Reports on the safety measures taken in foreign countries.
Summary of Results from Early Post-marketing Phase Vigilance and PSUR (Periodic Safety Update Reports: non-serious unknown, infectious disease)
Planning, Operation, PSUR and response to re-examination related to Treatment Outcome Study and Specific Treatment Outcome Study
Experienced Data management staff members and Statistician support you.
intellim will support you to draft your development planning, protocols and CRF (Survey sheet)
intellim also support you to negotiate with the medical institution for agreements.
Monitoring Support：Preparation of draft requisition form for re-examination, and direction to CRAs and MRs
Request for re-examination and collection of survey sheets
Consulting of all aspects of Pharmacovigilance, GVP and GPSP and others
Provide safety management services from early phases to late phase(PMS/Phase IV)
Data capturing to Safety DB
Available to utilize cloud safety database
Safety evaluation of AE(s)/ADR(s)
Domestic and global operations are providable.
Safety reports submission to authorities
CIOMS, SUSAR, Spontaneous report, preparation of SGML/ Individual Case Safety Report (ICSR)
Provide prompt operations to 7 days and 30 days report
Provide excellent medical translations
Periodic safety updatesre ports
Correspond to DSUR, PBRER, PSUR and reexamination reports
Consult Safety processes with high expertise for ICH M2/E2B
Support on mandatory processes
Transitional safety measures, Post marketing surveillance, Used result surveillance, Post launch surveillance
Support to draft Risk Management Plan
Provide training services to Safety personnel
AE/ADR Signal detection
For more information
If you have any comments, questions, please contact us.
To submit a more detailed RFI,
please contact us here.
intellim's Pharmacovigilance Services
