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Post-Authorization Safety Studies
When you need to conduct robust post-authorization safety studies, we work with you to deliver high-quality safety data that meets regulatory standards and prioritizes patient safety.
Improve Your Product Safety Assurance with PASS
Post-authorization safety studies (PASS) are instrumental in showcasing the superior safety profile of your products, improving market access, and meeting regulatory or HTA requirements. A well-designed and executed PASS provides crucial real-world data (RWD) that informs regulatory decisions and deepens understanding of your product’s safety profile and post-authorization outcomes. It also helps regulatory authorities and payers make informed decisions about product value.
Our priority is to deliver reliable and high-quality safety data for your product with thorough outcome validation for improved market access and patient safety. Conventional adverse event reporting often underreports events and observes only selected patient populations. In contrast, population-based database studies on safety provide a more comprehensive and efficient approach to address these evidence requirements. Cytel’s real-world evidence (RWE) experts leverage claims and registry databases to conduct robust PASS. In addition, we offer solutions for long-term registries and follow-up, pregnancy exposure studies, and HCP and patient surveys, ensuring a thorough and holistic approach to your research needs.
Contact usDiverse, Multinational Regulatory Expertise
We ensure your study execution is both tailored and comprehensive by customizing our approach to each country’s regulations and operational needs. While prioritizing adherence to the Food and Drug Administration (FDA) guidelines throughout study design and execution, we also proactively address potential data validity and representativeness challenges. Our deep understanding of regulatory frameworks ensures the success of your PASS. Our contributions have been incorporated into submission packages for regulatory bodies like the FDA, the European Medicines Agency (EMA), and HTAs.
Our Expertise in PASS: Ensuring Patient Safety Globally
Global to local support: We perform both national and multinational PASS. Cytel has developed a uniform framework to help you streamline activities across multiple countries for multinational studies. For example, we have exclusive access to German claims data, ensuring comprehensive and reliable insights for your research.
Unique insights and experience: We support you with capabilities in safety assessment, causality evaluation, risk minimization, drug utilization studies, health professional and patient surveys, and quantitative bias analysis.
Diverse databases expertise: Our experience with multinational databases allows us to fully harness the potential of RWD sources and ensure the validity of your safety data.
Recognized research expertise: Our commitment to excellence has earned us recognition as a research hub by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP Centre), collaboration with Flatiron, and being a EU2P Partner, underscoring our dedication to performing high-quality, impactful safety studies.
180+
RWE/HEOR experts worldwide, including seasoned senior staff with extensive experience in PASS.
300+
Peer-reviewed publications, focusing on externally controlled arm studies and comparative analyses using indirect evidence.
7,000+
Access to oncology network of 7000+ physicians
10
Years of experience of our senior RWE staff in PASS
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Book a free, no-obligation strategy session with a Cytel expert to get advice on how to improve your drug's probability of success and plot a clearer route to market.
