Complex and adaptive trial designs reflect the ongoing evolution in cancer research and demand more flexibility, precision, and innovation than traditional trials.
In this webinar, you’ll hear from the clinical development experts working with sponsors to unravel the complexities of these studies, offering a deep dive into the strategic approaches and innovative solutions essential for navigating them. Engage with these leading experts as they share insights, practical solutions, and forward-thinking strategies to address the most pressing challenges in regulatory compliance, statistical methodologies, and data management.
Whether you are a seasoned professional or new to the field, this webinar will equip you with the knowledge and tools necessary to excel in the evolving landscape of clinical research.
Register for this webinar to learn about regulatory navigation, effective data management, strategic approaches and innovative solutions essential for managing complex oncology clinical trials.
Speakers
Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials
Matt Cooper has 25 years of experience in the life science industry conducting clinical trials across all phases. His experience spans roles at sponsors, sites and the NHS, and he has extensive experience in site management and expanded use of oncology therapies. He is passionate about building effective relationships between industry stakeholders to drive innovation and patient access.
Jim Eamma, MSc, Executive Director, Therapeutic Strategy Lead, Oncology, Worldwide Clinical Trials
Jim Eamma’s experience in scientific and clinical research spans more than two decades and includes work in academic, clinical and CRO settings. Although oncology is his primary area of focus, he has also worked on clinical trials in several therapeutic areas. His intimate knowledge of studies at the level of the investigative site gives him the logistical and practical perspective needed for effective leadership and oversight.
Who Should Attend?
This webinar will benefit Vice Presidents, Directors, Managers, Department Heads, Scientists and Researchers working at pharmaceutical and biotechnology companies in the following areas:
- Clinical affairs
- Clinical R&D
- Clinical research
- Clinical operations
- Medical affairs
- Project management
- Regulatory affairs
- Strategic planning
What You Will Learn
Attendees will learn about:
- Navigating regulations: Simplified strategies for overcoming regulatory hurdles
- Statistical and data strategies: Insights into adaptive randomization, interim analysis and data harmonization
- Patient recruitment: Innovative tactics for effective enrollment
- Project Optimus and dosing: Understanding the impact of FDA’s new directives on trial design
- BOIN design insights: The growing significance of BOIN designs in trial outcomes
- PK and PD data essentials: The importance of PK/PD data in cohort decisions
- Global cohort dynamics: Managing cohort complexities across diverse locations
Xtalks Partner
Worldwide Clinical Trials
Worldwide Clinical Trials (Worldwide) is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications, from discovery to reality. Our full-service clinical development capabilities include bioanalytical laboratory services and Phase I-IV clinical trials, as well as post-approval and real-world evidence studies – all powered by our talented and accessible team of clinicians, scientists, and researchers who bring their first-hand expertise to each clinical program.
At Worldwide, we understand that each customer and project are unique, so we take a collaborative and personalized approach to identify and meet specific needs and goals. Anchored in our company’s scientific heritage, we are therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. We apply this deep therapeutic knowledge to develop flexible plans and quickly solve problems in the rapidly evolving clinical development landscape.
Our team of 3,000+ professionals spans 60+ countries, and believes that through collaboration, and a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays an important role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.
For more information, please visit www.worldwide.com or connect with us on LinkedIn.
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