Safety data evaluation and signal assessment
Let us 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
- Preparation of responses to safety questions from regulatory authorities, such as PRAC requests
- 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.
The challenge: Triggered by a spontaneous report of a fatal ADR associated with a generic drug, a European health authority questions the overall benefit-risk balance of the concerned product and requests from the originator MAH submission within 6 weeks of a full signal evaluation and benefit-risk assessment.
Our contribution: In close co-operation with the originator MAH and the generic company, Mark Waring Pharmacovigilance Services reviews all relevant data and prepares a response package including a signal evaluation report, benefit-risk assessment, and labelling update proposal within the requested time frame. Important bias is identified in two pertinent published pharmacoepidemiological studies and is highlighted in the submitted report as an alternative explanation for the suspected association.
The outcome: The proposed labelling update is accepted with minor modifications. The marketing authorisation is maintained without any modification to the approved indication.