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.
Speakers
Lisa Dawson, RN, Senior Director of Safety, Catalyst Flex
Lisa Dawson is a registered nurse with 17 years of industry experience in both pharma and CRO settings. Lisa worked in various positions of responsibility of pharmacovigilance management. Lisa was Manager of Pharmacovigilance in a large global CRO with oversight of global clinical trials in all phases, development of procedural documents, collaboration with pharmacovigilance physicians and administrative staff, the Clinical Project Teams and Data Management to ensure company SOPs and regulatory guidelines were followed. Prior to joining Catalyst, Lisa worked in the biotechnology space and with a large pharma company.
Message Presenter
Emily Anderson, RN, Principal Safety Specialist, Catalyst Flex
Emily Anderson is a registered nurse with over seven years of experience in pharmacovigilance and drug safety in the CRO setting. Emily has worked on clinical trial studies in all phases and post-market surveillance, including transitioning studies at various stages from one drug safety partner to another (rescue studies). She is a mentor and trainer for other staff drug safety team members.
Emily has worked to improve processes and efficiencies within all drug safety departments she has been a part of. Emily has a strong focus on maintaining individualized and collaborative client relationships and provides clear guidance on how to maintain a well-functioning study from a drug safety perspective that is efficient and compliant with global regulatory guidelines.
Message Presenter
Julie Van Orsdel Daves, MSHS, CCRP, President & Principal Consultant, JVD Pharma Consulting, LLC
Julie Daves has over 25 years of experience in clinical development operations strategy and execution. Julie holds an MSHS in Clinical Research from The George Washington University School of Medicine & Health Sciences, and a BS in Zoology/Genetics from North Carolina State University. She has led teams to deliver complex, cross-functional clinical studies and programs in over 40 countries in multiple complex therapeutic areas. Her leadership roles span both small/mid-size biotechs and CROs; most recently she has served as Vice President of Clinical Development Operations for several small and mid-size biotechs.
Message PresenterWho Should Attend?
This webinar will appeal to Director level and above in the following fields:
- Clinical operations
- Data science, biometrics and data management, biostatistics, programming
- Site clinical trial staff
- Procurement/outsourcing
- Project management
- Medical writing
- PVG/safety
What You Will Learn
Attendees will learn about:
- How to hire team members to support a culture that aligns with an intentional approach
- Why a global approach is necessary and how such an approach supports clients and the need for responsiveness
- Identifying when it is time to bring in a new safety provider and how to minimize disruptions
Xtalks Partner
Catalyst Flex
Catalyst Flex, a solution of Catalyst Clinical Research, provides global functional services delivered by experts in clinical operations, data management, biostatistics and programming, safety and pharmacovigilance, and medical writing for the biopharmaceutical and biotechnology industries. As a functional service provider (FSP), Catalyst Flex supplies people, process, and technology solutions designed to meet each client’s unique clinical trial needs. Catalyst Flex’s flexible service model comes from more than a decade of listening to customers, devising customer-centric solutions, and helping customers advance clinical studies by leveraging expert teams and innovative technologies.
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