Post-marketing surveillance (PMS) refers to the collection of safety and/or efficacy data once a new therapy has received marketing authorisation (or conditional marketing authorisation). This is often mandated by medicines regulators and allows for the collection of long-term data in the clinical setting.
The wide expertise within TREAT-NMD allow us to contribute to post-marketing studies as an independent partner to pharmaceutical companies or clinical research organisations.
We work alongside our registry network and project partners to facilitate access to data that offers accurate and reliable measures of patient health and wellbeing.
TREAT-NMD is fully GDPR compliant, and our infrastructure is regulatory compliant. Our project management team, who have significant commercial and scientific experience, are responsible for TREAT-NMD’s role in post-marketing studies, and operate a flexible hybrid Prince2 project methodology.
We are proud to work with the Life Sciences Industry and Clinical Research Organisations in the design and management of robust and effective processes for PMS. Our collaborations ensure that safe and efficacious treatments for rare neuromuscular diseases will reach patient populations to improve health and quality of life for patients and their families.