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Drug Safety / ISO ICSR

Better safe than sorry

​​​​​​The risk of adverse events or side effects is always present in clinical development and the post marketing of medicinal products. So it is little wonder that companies and regulators are increasing scrutiny to improve the safety of drugs, for instance through GVP and the upcoming ISO ICSR standard used in E2B (R3) safety reporting.

NNIT can help you implement and maintain a safety reporting system that enables you to react swiftly and comply with regulatory requirements. We offer a number of safety systems including ArisG and Oracle Argus, configuration-based pharmacovigilance safety suites that provide complete case management and regulatory reporting functionality.

We have the necessary business knowledge and process experience within pharmaceutical development to help you decide upon the best solution for your organization, as well as the technical capabilities to ensure daily operation and the seamless integration with your existing systems and SOPs.

For the upcoming ISO ICSR requirement, NNIT can help you build the conversion between the R2 and R3 formats and prepare the business for the upcoming process and system changes.




 

 

Rasmus Koch Nelund+45 3079 6411rmne@nnit.com ​​​Vice Presidenthttp://www.linkedin.com/in/rasmusnelundRasmus Koch Nelund