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Periodic review of safety data is a cornerstone of ongoing benefit risk evaluation. Periodic safety reports are mandated for all medicinal products, independent from development stage.

ONE–OFF PSUR and Annual Safety Report writing:

In times of peak workload, pressing timelines or competing priorities: spm2 would write reports on demand according to your standards and SOPs. We promise timely delivery and high quality reports.

Implementation of periodic report writing systems:

In addition we could offer you to build a complete PSUR writing system, including SOP development, templates and mock reports, data presentation and evaluation, implementation of workflows, training of staff, quality control etc..

spm² possesses a wealth of experience in PSUR and annual safety report writing.

Our physicians have written reports

  • in oncology,
  • CNS,
  • infectious diseases,
  • cardiovascular and
  • gastrointestinal indications.

We have provided large and small volume reports and would offer you a tailor made report writing.