Pharmacovigilance in Clinical Trials: Where Safety Meets Smart R&D
In clinical research, safety builds credibility.
Pharmacovigilance (PV) keeps trials safe, compliant, and inspection-ready — ensuring every participant’s well-being and every data point’s reliability.
And for sponsors running clinical trials in Australia, partnering with an experienced PV service provider delivers more than compliance confidence — it can also unlock valuable R&D tax savings.
Why PV Matters in Clinical Trials
Every trial generates safety data that needs expert handling — fast, accurate, and compliant with ICH, TGA, EMA, and FDA standards.
A trusted PV partner can manage:
- Safety set up: Safety Management Plan preparation
- Adverse event and SAE collection
- SUSAR assessment and reporting
- Safety database hosting (e.g., Argus, ArisG)
- Medical monitor
- DSUR preparation and ongoing signal review
- PV intelligence
This ensures regulatory compliance, inspection readiness, and peace of mind — from study start-up to closeout.
The Australian Advantage
Australia’s R&D Tax Incentive (R&DTI) recognises clinical trials — including pharmacovigilance — as eligible R&D activities under the Clinical Trials Determination.
That means PV costs like safety monitoring, SAE processing, DSUR preparation, and database management when undertaken in Australia by appropriately qualified professionals may form part of your eligible R&D spend when directly linked to the trial.
The Takeaway
Pharmacovigilance protects patients and data — and when structured as part of your clinical strategy in Australia, can also benefit your bottom line.
By partnering with a qualified PV service provider and leveraging Australia’s R&D and grant ecosystem, sponsors can achieve the perfect balance of compliance, safety, and financial efficiency.
Reach out to our Patient Safety team at @CommercialEyes if you would like to discuss your clinical trial patient safety strategy in more detail [email protected]
Lorenza Ricacho
Regional Head of Patient Safety
Lorenza has been with Commercial Eyes since 2011 and leads our Patient Safety and Risk Management team supporting our clients from the pharmaceutical, medical devices, generics & OTC, cosmetics sectors...
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