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,
- infectious diseases,
- cardiovascular and
- gastrointestinal indications.
We have provided large and small volume reports and would offer you a tailor made report writing.