CAN WE OPTIMISE YOUR SURVEILLANCE?
Phlox PVMed Consultancy offers full support of safety surveillance including
- setting up robust surveillance processes with pragmatic documentation that is end user friendly
- create a bespoke surveillance strategy for products with complex requirements, including advanced therapeutic medicinal products (ATMPs), specific potential risks or vulnerable patient populations
- review of process to ensure compliance with all international regulations
- pragmatic and time efficient solutions for performing and documenting effective surveillance rather than a simple “box ticking excercise” to ensure regulatory inspectors are satisfied
- clear analysis and summaries to support decision making regarding risk based approaches to safety surveillance and clinical trial monitoring
- supporting the implementation of AI tools to ensure continued compliance with regulatory requirements and clear understanding of the caveats and limitations of the intended use.