Vaccine studies often rely on rapid and efficient execution across global, multi-center populations. However, strategies for accelerating trials must never compromise data integrity or regulatory compliance.
In this vaccine-focused webinar, Clario’s experts will discuss the evolving standards for safety and toxicity grading within vaccine trials, along with best practices for designing reactogenicity diaries that capture local and systemic symptoms accurately. The session will explore why Bring Your Own Device (BYOD) is often the preferred modality for modern vaccine trials when considering participant burden, data integrity and speed. It will also examine how electronic diaries (eDiaries) can improve accuracy and provide regulatory-ready data for faster and accurate decision-making. The unique challenges and considerations for assessing cardiac safety in vaccine development will also be discussed.
Register for this webinar to discover how advanced eCOA, cardiac monitoring and digital endpoints can ensure your vaccine trials meet the highest standards of quality, safety and regulatory readiness.
Speakers

Todd Rudo, MD, EVP & Chief Medical Officer, Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety.
Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high-quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.

Saima Khakwani, Scientific Advisor, eCOA Science and Consulting, Clario
Saima Khakwani is a Scientific Advisor at Clario and the internal subject matter expert for vaccines. She specialises in eCOA design, with a focus on reducing patient burden and improving data quality through best practices in diary design, including the use of paper and free text.
With over six years of experience supporting Phase II and III trials across multiple therapeutic areas, Saima has led scientific contributions in oncology, respiratory, pain, diabetes, cardiac disorders and vaccines.
Saima continues to contribute to internal research aimed at improving the quality of clinical trial delivery and has authored and co-authored numerous scientific publications.

Fabian Chen, MD, PhD, VP and Deputy CMO, Cardiology, Clario
Dr. Fabian Chen is Deputy Chief Medical Officer – Cardiology and Vice President at Clario. In addition to providing leadership for Clario’s Cardiac Safety department, Dr. Chen offers expert consultation to clients on scientific and regulatory strategy. Dr. Chen has nearly 20 years of clinical cardiology and pharmaceutical research experience. Recent positions include Chief Medical Officer at the University of Pennsylvania Gene Therapy Program and Vice President of Clinical Development at Rocket Pharmaceuticals. Dr. Chen also has over 10 years of experience in both early and late-stage clinical development, working at Merck and Novartis Pharmaceuticals.
Fabian received his undergraduate degree from Harvard College and his MD and PhD from Yale University. He completed his internal medicine and cardiology training at the University of Pennsylvania School of Medicine. Prior to entering the pharmaceutical industry, Fabian was a faculty member of the departments of Medicine, Pediatrics and Molecular & Cellular Physiology at the University of California, Los Angeles.
Who Should Attend?
This webinar will appeal to clinical trial professionals in the following fields or having the following titles:
- CEOs/Chief Medical Officers/Chief Scientific Officers
- Clinical Data Managers/Clinical IT/Clinical Monitoring
- Clinical Operations/Clinical Development
- Clinical Research/Clinical Pharmacologists/Clinical Scientists
- Data Science/Health Economics and Outcomes Research
- Imaging Scientists/Medical Affairs/Medical Monitor/Head of Development for Program
- PK Experts/Protocol Managers/Regulatory Affairs
- Sr. Managers, Trial Initiation
What You Will Learn
Attendees will gain insight into:
- Regulatory alignment: Apply FDA and EMA safety and toxicity grading guidance to keep eCOA data in vaccine trials compliant with regulatory standards
- Effective symptom tracking: Incorporate Bring Your Own Device (BYOD) solutions and well-designed reactogenicity diaries to improve compliance, reduce participant burden and capture accurate, timely data
- Electronic Participant-Reported Outcomes (ePROs): Implement eDiaries to improve accuracy, minimize errors and deliver near real-time, regulatory-ready data for faster decision-making
- Cardiac safety assessment: Understand appropriate incorporation of ECG and cardiac imaging in vaccine trials, with case discussion of vaccine-related myocarditis
Xtalks Partner
Clario
Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence-generation solutions that combine medical imaging, eCOA, precision motion, cardiac and respiratory endpoints.
For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have been deployed over 30,000 times to support clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2012.
For more information, go to Clario.com or follow us on LinkedIn.
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