Safety Data Assessment and Signal Evaluation

We can help you understand your pharmacovigilance data and support you when pressing time lines need to be met. Examples of our data assessment and signal evaluation services include:

  • Strategic advice on how to approach your safety question
  • Structured, systematic evaluation of pharmacovigilance data sets, both large and small
  • Literature research, review and critical appraisal
  • Full safety signal evaluation and documentation in compliance with applicable guidelines such as GVP Module IX - based on materials provided by your organisation and/or own research
  • Benefit-risk assessments
  • Medical assessment of single ICSRs.

We evaluate your pharmacovigilance data systematically, comprehensively, scientifically and - if necessary - quickly. We understand the ethical, regulatory and business implications that might arise from evaluation of safety data and liaise closely and sensitively with our customers while doing so.