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Patient Safety & Risk Management

Ensuring patient safety throughout a product's lifecycle

A trusted partner for the medicines and medical devices industry

We have developed a comprehensive and ISO accredited service that operates across 20 jurisdictions in Asia-Pacific, Canadian, the EU and the United States. Providing high-quality patient safety & risk management that starts at a product’s development stage and going into post-marketing surveillance.

Our processes are based on a robust Quality Management System, ISO 9001:2015 accreditation and the integration of industry best practice. We have also been inspected by the FDA in 2015 and the TGA 9 times since 2018, with no critical findings identified. We are extremely proud of these results, which continue to confirm our position as the foremost pharmacovigilance and medical information provider in the region.

We can help you

At Commercial Eyes we understand the importance of progress and have invested heavily into our technological capabilities, to allow for the high volume of safety processing in-house, and fully functional remote working services.

Our distinct solutions for your business include the Oracle Argus Safety Database and a dedicated Patient Safety team.

Management of local and global PV Systems
Support for clinical trial and post-marketing surveillance
Coverage of all vigilance requirements for devices, vaccines and medicines
End-to-end ISCR management, medical review, signal detection and aggregate reports compilation
RMP and ASA development
Preparation of safety database exchange agreements
Sponsor representation as the health authority contact person and qualified person for pharmacovigilance in AU & NZ
Inspection readiness activities including implementation of internal and partner PV audits

Patient Oriented Programs
- Patient Access Program
- Product Familiarisation Program
- Sampling and co-pay programs
- Patient Support Program
- Nurse Support Program
- Allied Support Programs
- Clinical Audits
- Chart Reviews
- Risk management programs
Collaborative database design, validation and management
Digital platform
App development
Enrolment and registration management
Inbound/outbound call management
Notifications management
Program Administration
Pharmacy administration
Reporting metrics and reconciliation

OUR IMPACT

9

TGA Inspections with no critical findings

30+

Client audits on average per year

37+

Clients where CEPL is the nominated QPPV-A and/or CPPV-NZ

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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