ICSRs Processing and Submission
We provide a cost-effective solution for managing safety data and taking care of your future requirements for processing ICSRs and enabling global reporting on time
Fidelity Health Service has an entire suite of drug safety solutions to ensure patient safety is protected throughout the lifecycle of a drug. Our team of experts has a deep understanding of regulations and is at the forefront of providing analysis and generating insight that adds to the quality of life. We are committed to advancing patient safety with data, drive, and decisiveness.
We provide a cost-effective solution for managing safety data and taking care of your future requirements for processing ICSRs and enabling global reporting on time
As a team of literature reviewers, we use carefully crafted search strategies to screen adverse events that contribute to case processing, aggregate reports, and signal management.
We support you with routine and ad-hoc aggregate reports for every stage of drug life cycle including development and post-marketing phase. Our team manages all the activities related to the creation and submission of first time-right reports.
We pore through every element of adverse event data to identify patterns and propose new safety information and activities triggered by the discovery of a new signal.
Signal
Detection
Signal Validation
and Confirmation
Signal Analysis
and Prioritization
Signal
Assessment
Recommendation
for action
We emphasize a rational approach for identified and potential risks. FHS team of specialists designs a specific and accurate minimization measures towards the risk. FHS compiles, composes, and updates risk management plans (RMPs) for various regulators globally. Our prime objective is to identify potential problems and address any issues that may arise before they escalate.
