Our service for you when contacting the reporter

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Follow-up Management

  • FU Request to reporter
  • Contact Management
  • Special Process (e.g. pregnancy / breastfeeding)
  • Reporting Time Frame Allocation
  • Cross-Check for product defects
  • Archiving according to Data Privacy Laws
=> Accurate follow-up for missing / unclear data, progress, and outcome

We gladly support you regarding the direct contact to the reporter of the respective AE, in order to collect follow-up data (according to Vol 9A) and, if required, to respond to requests regarding medical science or sales returns according to previously agreed template texts.

When contacting the reporter by phone we prepare standardised phone notes as Source Documents. In case of contacting the reporter by mail, we send you a draft of the letter or we send the complete letter with inserts directly to the reporter.