Pregnant and Breastfeeding Patients Who Use Your Company's Products Deserve To Be Heard. We Developed Innovative Solutions to Bring You Their Data Fast

Every pregnant and breastfeeding woman is unique, and collecting their data requires a tailored approach with an eye for quality and efficiency. We pride ourselves on our ability to bring our collective knowledge and expertise in Drug Safety Operations to all of our partners:

  • Analyzing data collection requirements
  • Identifying and implementing innovative and effective strategies, processes and technology solutions
  • Tailoring our comprehensive service to match individual situations

Combining the latest technologies with years of Drug Safety Operations experience, our team adopts an intelligent approach to developing and implementing quality data collection solutions. We use a suite of techniques to identify and resolve data discrepancies and assure data quality.

Individual Case Safety Report (ICSR) Management (pre- and post-marketing):

  • Case Receipt and Data Entry
  • MedDRA, WHO-Drug Dictionary Coding
  • Narrative Writing
  • Quality Control
  • Assessment and Medical Review
  • Submission of Reports to Health Authorities and Stakeholder
  • Health Authority Liaison

Contact us now to see how we can help you

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