Safety reports & writing

Whether an unscheduled PSUR request pops up out of nowhere or your PV function is just chronically understaffed: we can help you get that report out on time and in good quality. We have extensive experience in authoring clinical and postmarketing period safety reports – both big and small and for a wide range of products. Report formats include for example:

• Periodic Safety Update Report (PSUR)
• Periodic Benefit-Risk Evaluation Report (PBRER)
  
• Addendum to the Clinical Overview (AddCO)
  
• Development Safety Update Report (DSUR)
  
• Periodic Adverse Drug Experience Report (PADER)
• Protocols and reports for post authorisation safety studies (PASS)
  

We can contribute individual sections or produce full, ready-to-submit regulatory documents. In either case, format and content are in line with all applicable regulations and guidelines such as GVP, ICH, US CFR and CIOMS, as well as in compliance with your organisation's procedures and standards. We can also advise and support you with other product safety documents, such as labelling documents (CCDS/CCSI, SmPC).

The challenge: An initially assigned service provider fails to deliver a PBRER draft for a major oncology product with more than 20 safety topics and >4000 new ICSRs. To ensure compliance with regulatory submission timelines, a full draft report is required within 10 calendar days.

Our contribution: Mark Waring Pharmacovigilance Services steps in immediately and finalises the PBRER draft in acceptable quality, within the ambitious timeline.

The outcome: The report is submitted on time. There are no comments on report quality in the corresponding PSUR assessment report. The client decides to outsource preparation of future reports for this product to us.