Development support.
How Clinical Safety impacts your trial outcomes.

What is vigilance within Clinical Safety?

Ensuring clinical safety pharmacovigilance within your clinical trials is paramount to the success of your organization’s global drug development efforts, and while your clinical research holds the promise of groundbreaking medical breakthroughs, it demands unwavering and meticulous attention to detail.

This entails comprehensive clinical risk management, as well as the rigorous implementation of safety protocols and procedures aimed at mitigating potential harm, minimizing medical errors, and averting adverse events and other hazards.

Pharmacovigilance within clinical safety extends its focus to the oversight of all safety management aspects throughout your clinical trial. This starts from the initial planning stages and Safety Management Plan, progressing through trial setup, monitoring, case reporting, and all the essential administrative tasks and documentation requirements.

This is essential not only for the well-being of trial participants but also for the integrity of the data collected, and the overall success and safety of your clinical research outcomes.

Click for further information from the European Medicines Agency.

Why choose Aegisana for your Clinical Safety requirements?

Whether your research spans diverse international settings or adheres to specific national guidelines, our team of clinical trial safety consultants can ensure each phase proceeds with meticulous precision and an unwavering focus on detail.

Tailored Safety Management.

We provide expert guidance on structuring the safety management of your trial. This includes a thoughtful consideration of factors such as study phase, indication, subjects, and other stakeholders involved in trial execution, all while maintaining a keen eye on your budget.

Comprehensive Safety Plan.

Our team can either prepare or methodically review your Safety Management Plan. This includes the creation of all associated forms, from Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) to Pregnancy Notification/Outcome, and Adverse Events of Special Interest (AESI) reporting.

Strategic Partnership.

We understand the value of our services goes beyond individual trials. That’s why we offer strategic partnership opportunities to collaborate across your development portfolio. By aligning with us at a strategic level, you benefit from our wealth of expertise and experience, enhancing the overall success and safety of your projects.

Reliability and Assurance.

We recognize the importance of meeting investor commitments and deadlines. Our commitment to delivering expert advice and on-time project deliverables is unwavering. Trust is paramount, especially in the early stages when pharmacovigilance and regulatory processes may not yet be fully established. 

A reliable choice to grow with.

At every step of the way, our goal is to provide you with the peace of mind that comes from a reliable partner in clinical safety, backed by a team of experts dedicated to your success.

As your needs evolve, we ensure we have the breadth of services, experience, and a proven track record to grow with you, maintaining that continuity and commitment throughout your journey.