Drug Safety

Advancing Patient Safety with
data driven decisions

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.

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

Literature Management

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.

Aggregate Report 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.

  • DSURDevelopment Safety Update Report
  • PADERPeriodic Adverse Drug Experience
  • PBRERPeriodic Benefit Risk Evaluation Report
  • PSURPeriodic Safety Update Report
  • ASRAnnual Safety Report
  • ACOAddendum to Clinical Outcomes

Signal Management

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 Validation
and Confirmation

Signal Analysis
and Prioritization


for action

Risk Management Plan

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.

Safety information reviews & revisions
All sections of
medical assessments
Full safety
Efficient risk minimization measures

What makes us preferred
Drug Safety partner

In an ever-changing pharmacovigilance landscape, we give you the confidence you need in your Drug Safety solution
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