Signal management

Signal Sentinel^® – efficient and cost-effective

In accordance with the AMG and Guideline on Good Pharmacovigilance Practice (GVP), as part of their pharmacovigilance activities, marketing authorisation holders are obliged to provide signal detection and immediate information about newly discovered risks or a change in the benefit-risk profile of the drug to the respective higher federal authorities and the EMA.

In order to provide marketing authorisation holders with targeted support in fulfilling this obligation, we offer the database-driven Signal Sentinel®, which is a powerful and efficient instrument for signal management.

• Individual report

   

  We prepare complete signal detection reports for you according to the Signal Sentinel method – with side effect reports, literature reports, and authority reports. In addition, there are data from sponsored and published studies. This is followed by signal validation, analysis, and evaluation as well as concrete recommendations for action.

• Pooled report

   

  The literature-based, drug-related part of the Signal Sentinel® report is provided digitally as a master with tabular display of the side effects from literature reports. In addition, the report shall include:

  • • Discussion of the published studies
    • List of sources
    • Line listing of literature cases
    • Notes on further processing of the report

• Signal management-SOP

   

  The purpose of this SOP is to ensure that the signal management for drug risks of a medical nature carried out by companies or their contractors (must be evaluated and documented to fulfil the pharmacovigilance requirements) is carried out according to a uniform procedure and in accordance with regulatory requirements.

   

  By complying with this SOP, signals indicating a change in the benefit-risk profile of a medicinal product by a company can be identified and evaluated, and appropriate action can be taken in a timely manner.

Would you like to know more?

We are pleased that you are interested in our signal management services. We would be happy to present our working methods in detail – just contact us.