Triage is the process of assigning the priority on a case to be processed and to assist in completing the case processing related activities within the required regulatory timelines and as per standard operating procedures.
Our professionals of specifically trained triage team can assess the individual case safety reports (ICSR) with good quality and assess the seriousness criteria, expectedness, listedness within the turnaround time of 24 hours from the receipt of the initial case.
We have specific quality review team set up to review the cases triaged and analyze the specific needs and analysis to provide better triage solution and help better assessment of ICSRs.
We would provide 24/7 triage services for ICSRs and help you in reaching the specific timelines and make the case available for processing at the earliest.
We have the dedicated team of ICH-GCP certified and experienced professionals for processing of individual case safety reports with required quality within the required timelines.We process serious and non-serious ICSRs from different source be it clinical trial, solicited or spontaneous cases and from literature source.
Our ICSR processing team is well-versed with MedDRA coding for adverse event selection, assessing the expectedness for the events and evaluating the listedness assessment between the event and the drug.
Our trained case processing team provide you with narratives for ICSR in details and in compliance with the client and regulatory requirements to help and analyze the case in a summarized format.
We have a dedicated quality review team to perform quality checks post ICSR processing and provide in-depth analysis to help improve the process. Our team is well trained in processing all types of ICSRs in view with the regulatory requirements from different countries and required ICH-E2B guidelines.
We have highly dedicated and trained team of healthcare professionals to review the medically relevant information in the ICSRs and provide in-depth analysis on assessment between the drug event pair and helps in providing the safety analysis of the product.
Medical professionals make sure that the appropriate MedDRA coding term is selected and assess the expectedness and listedness for the event.
Medical review team help in providing the in-depth analysis of the events reported for that particular product and help in the signal detection and risk management for that particular product.
With quality parameters in place, medical review team makes sure that the case quality in terms of medically relevant information is as per the required service level agreement.
INTERNATIONAL STANDARD OF ICSR QUALITY REVIEW PROCESS