This webinar will explore strategies to build a comprehensive approach to endpoint protection in rare disease clinical trials, thereby ensuring the integrity and reliability of study outcomes. The integrity of clinical trials depends on accurate and reliable data, making the protection of endpoints a critical aspect of the entire process. Endpoints, which are specific outcomes used to measure the effectiveness of an intervention, must be safeguarded to ensure the validity and credibility of the trial results. Endpoint protection is particularly important in rare disease trials as these studies often involve small patient populations and face distinct methodological challenges. Every data point is essential to the success of the study.
Join this webinar to gain insights into essential strategies for constructing a robust framework for endpoint protection in rare disease clinical trials.
Speaker
Angi Robinson, Senior Vice President, Specialty Areas, Premier Research
Ms. Angi Robinson has been designing and conducting specialty studies, including pediatric and rare disease studies, for more than 22 years. She has provided strategy, oversight and full management support for rare disease studies at Premier Research for over 18 years, including global programs in ultra-rare indications.
Ms. Robinson has a thorough understanding of drug development with extensive supervisory experience and management in conducting registrational-enabling clinical trials for orphan drugs. Ms. Robinson’s experience encompasses complex study designs such as PK/PD and adaptive design, and she has worked with products granted expedited designations by the agencies like FDA Fast Track, Breakthrough Therapy and PRIME designations — including advanced medicines. Specifically in orphan drugs, Ms. Robinson has supported 10 products resulting in FDA and EMA approval.
Ms. Robinson earned a bachelor’s degree in cell and molecular biology from Tulane University in New Orleans, LA.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited, to:
- Clinical operations
- Medical affairs
- Project management
- Regulatory affairs
What You Will Learn
Attendees will gain insights into:
- Agency guidance and reference
- Strategies for ensuring quality clinical research organization (CRO) oversight of clinical data
- The role of technology and data visibility in driving informed decision-making
- Real-world case studies demonstrating the value of proactive endpoint protection
Xtalks Partner
Premier Research
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
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