Pharmacovigilance encompasses surveillance of adverse events after short-term and long-term use of medicines. We offer the following services on safety reporting:
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Dedicated persons and fax line to receive reports of SAEs at all times
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SAE collection, evaluation and classification
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SAE reporting as per sponsor's guidelines and safety related information
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Regular monitoring and reporting within international reporting time frames
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Follow-up with the sites and preparation of summary reports for onward submission to sponsor, ethics committee, regulatory bodies locally
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Addressing safety issues in a comprehensive and accurate manner
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Services
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