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Drug Safety and ICSR Reporting

Drug Safety – MedInfo and ICSR Reporting

Samarind RMS’s drug safety module is fully integrated into the main package. As well as providing the ability to capture all the details associated with an adverse reaction and handling the transmission of the associated ICSR to the relevant authority or third party, it provides the ability to link adverse reaction information to the associated marketing authorisation, manufacturers and active ingredients as recorded in the regulatory part of the system.

As with the rest of the system, data entry is quick, easy and flexible, while still offering the security and auditability that is so important to everyone involved in the pharmacovigilance field.

Our Med Info section allows for the easy capture and tracking of all the information related to medical information enquiries. Entries are date and time stamped and automated alerts ensure that queries are dealt with in a timely manner, depending on the type of enquiry. Details can be linked to the appropriate active ingredient and/or product licence for future analysis and entries can be routed through to the relevant department as necessary.

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