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Xtalks, Online
2025-04-23
Effective collection and continuous monitoring of patient safety data in clinical trials is essential to protect patients and detect important safety signals. A robust safety database is crucial for accurately assessing and characterizing the risks of new drugs. Decisions about the safety and efficacy of investigational drugs, devices or therapies rely on the integrity of collected trial data, making timely and accurate safety reporting vital in clinical research.
In this webinar, learn how a different approach to safety is particularly helpful supporting the advancement of drug development programs. Each patient, study and serious adverse event (SAE) is unique, and their stories need to be told in a distinctive way. Providing high-quality, non-assembly line case processing is safeguarded by intentionally choosing tenured case processors who display a higher level of quality.
Assigning a Lead Safety Specialist to every project has proven successful for guidance, budget management and quality assurance. The expert speakers will discuss the critical role of the Lead Safety Specialist and the benefits of leveraging their medical training and expertise, pulling from their wealth of previous experience in bedside nursing to develop strong safety narratives that create accurate and efficient clinical study reports.
Cultural values, specifically listening and flexibility, are often underemphasized when in fact they are critical pillars in the delivery of safety services to clients. An intentional hiring process can ensure that team members align on key values and bring their talents to support each client, study and safety event with the utmost attention.
Register for this webinar today to explore a patient-centric approach to safety data collection and monitoring in clinical trials.
Keywords: Clinical Trials, Drug Development, Drug Discovery, Clinical Research, Drug Safety, CRO, Patient Safety, Pharmacovigilance, Investigational New Drug, Clinical Data, PV, Data Management, IND
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Organized by:
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Xtalks |
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Invited Speakers:
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Lisa Dawson, RN, Senior Director of Safety, Catalyst Flex
Emily Anderson, RN, Principal Safety Specialist, Catalyst Flex
Julie Van Orsdel Daves, MSHS, CCRP, President & Principal Consultant, JVD Pharma Consulting, LLC
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Deadline for Abstracts:
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2025-04-23
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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