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Within the scope of clinical trials, THERAPHARM is
able to arrange the entire management of adverse events in
either a French or European trial.
Depending on the Sponsor's request:
- Investigators' training (definitions, regulatory information, SOPs, ethical conduct, responsibilities).
- Assistance to Investigators for the management of Serious Adverse Events (SAEs), i.e.
- documentation of early report forms (minimal data required, available data),
- contacts with the Sponsor,
- follow up and documentation of follow-up report forms taking account of the event outcome and Sponsor's questions.
- Early and follow-up reports to Health Authorities.
- Notification to Ethics Committees and relevant Investigators.
- Summary reports for Health Authorities and Ethics Committees
- Follow up of adverse event recording during the study.
- Reconciliation of data bases.
Our objective: your quietness.
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A wide range of services
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