Our safety specialists collect, collate and assess individual cases safety reports received spontaneously or elicited within surveillance programs.
We ensure compliance with timelines, efficient handling and continuously high quality of the assessment.
Our service includes:
- Collection of case reports from clinical trials and
- spontaneous reporting systems,
- identification of duplicates
- Literature search
- Follow up with reporters and query processes for missing information
- Evaluation and MedDRATM coding
- Data entry in client’s or spm2 safety database
- Electronic or paper reporting of expeditable cases to competent authorities