Individual Case Safety Reports

Our data management drives you to safety.

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What to Know

An Individual Case Safety Report or ICSR, gathers and assembles reported data about adverse events, complaints and other product issues. ICSRs are an important part of your pharmaceutical production and approval process. We prepare ICSRs to Health Level Seven standards.

Health Level Seven refers to a set of voluntary, international guidelines and methods. The HL7 standards are a significant part of ICSR activities because they establish protocols for how healthcare software programs communicate data to each other. These standards have been adopted by other safety and compliance bodies such as ISO and ANSI. Understanding and implementation of HL7 standards ensures proper data management.

How We Can Help

We can provide experienced ICSR consultants for your pharma product. Specializing in drug safety, the consultant(s) you choose can manage single aspects or comprehensive case processing. We can work with your in-house database or provide a validated, E2B compatible, total case processing solution.

  • Data collection
  • Database entries
  • Comprehensive coding
  • Medical assessment
  • Regulatory submissions