Are you ready to revolutionize the world of clinical trials and embrace the immense potential of mobile technology? We are excited to present our exclusive webinar on “FDA Requirements for Creating New Mobile Endpoints for Clinical Trials.” This is a rare opportunity to gain invaluable insights into the latest breakthroughs in clinical research and harness the power of novel endpoints to transform patient-centric assessments.

The FDA has established clear regulatory guidelines for mobile endpoints, emphasizing validation, data integrity, and patient safety. Per the FDA’s 2023 Digital Health Technologies for Remote Data Acquisition guidance, mobile endpoints must meet rigorous standards for accuracy, reliability, and reproducibility. The speaker, Dr. Mukesh Kumar will break down these regulations, highlighting key compliance requirements such as ensuring data security under 21 CFR Part 11 and validating sensor-based endpoints for clinical relevance.

Attendees will gain actionable insights into designing mobile endpoints that align with FDA expectations, including strategies for minimizing bias in data collection and ensuring endpoints are fit-for-purpose. Dr. Mukesh Kumar will share expert suggestions, such as leveraging real-world evidence to support endpoint development and engaging early with the FDA through the Pre-Submission Program to clarify regulatory pathways. He’ll also discuss common pitfalls, like inadequate validation protocols, and how to address them effectively.

This webinar is essential for clinical trial professionals aiming to innovate with mobile technology while staying compliant. Register now to learn from Dr. Kumar’s extensive experience and ensure your mobile endpoints meet FDA standards for successful trial outcomes. This session will provide critical insights into the evolving landscape of mobile endpoints in clinical research.

Why should I attend:

1. Empower Patients: This webinar focuses on identifying aspects of health that matter most to patients. By leveraging mobile technology, we can now assess these new endpoints with ease, ensuring that our clinical trials are centered around patient needs and preferences.
2. Unleash Your Potential: Through novel endpoints, we unlock the potential for larger and more sensitive trials. Reduced barriers to participation mean we can gather data from a more diverse pool of participants, leading to more comprehensive and generalizable results.
3. Obtain High-Quality Data: With the right measurement approaches and suitable mobile devices, we guarantee high-quality data collection, minimizing systematic measurement errors and ensuring the accuracy and reliability of our assessments.
4. Identify the Most Relevant Endpoints: Learn to identify and prioritize aspects of health that truly matter to patients, ensuring your clinical trials address their needs effectively.
5. Optimize Measurement Approaches: Discover how to select the most appropriate measurements, reflecting the intended scope of assessment and enabling meaningful changes to be interpreted as treatment benefits.
6. Embrace Mobile Technology: Understand how to leverage cutting-edge mobile devices for data capture, making your clinical trials more efficient, patient-friendly, and precise.
7. Set Standards and User Manuals: Develop robust standards and user-friendly manuals for the intended study population, making the adoption of novel endpoints seamless.

By participating in this training, you will be equipped with the necessary tools to expedite the adoption of novel endpoints in your clinical trials. The speaker will provide hands-on guidance, ensuring you gain practical skills that can be implemented immediately.

Who will benefit: 

• Clinical Trials Professionals
• Regulatory affairs professionals
• Clinical Research Managers and Associates
• Principal Investigators
• Site Managers and Research Coordinators
• Contract Research Organizations (CROs) Staffs
• Institutional Review Board (IRB) Members
• Drug discovery and development professionals (R&D and CMC)
• Clinical trial managers 
• Project Managers and Clinical trial specialists
• Pharmaceutical and Biotech Industry Professionals involved in clinical trial planning and execution.