Clinical Trial Safety

What are the benefits of early PV partnerships during clinical development?

Strategic foresight that streamlines the drug development process and lays the foundation for robust patient safety data  

At Allucent, we emphasize the significance of establishing early PV partnerships. Our proactive approach ensures that our clients benefit from a well-crafted PV strategy right from the outset.  

By collaborating closely from the early stages of clinical trials, we offer tailored solutions that align with our customers’ specific needs. This strategic foresight not only streamlines the drug development process but also fortifies the foundation for robust patient safety, through early centralization of safety data.   

Allucent’s approach offers multiple benefits, from operational efficiency, simplified sponsor oversight and improved safety surveillance across studies.  It also prepares our clients for a seamless transition to expanded access and compassionate use programs and into post-marketing surveillance.  

Conducting ph III studies and considering a regulatory filing in the next 6-12 months?

Ensure pharmacovigilance systems and processes are established to avoid delaying regulatory submissions.

At Allucent, we support companies in the preparation for a regulatory filing by setting up the post-marketing PV system in advance. Within Europe this is mandated by legislation and ensures that relevant systems and processes can be established without delaying regulatory submissions.

Allucent technology and expertise supports customers with the development of a global safety database and the migration of legacy data in readiness for post-marketing pharmacovigilance and safety monitoring.