Bioforum The Data Masters
On-demand
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Wednesday, July 24, 2024 · 10:00 AM EDTIntegrated summaries of efficacy (ISE) and safety (ISS) are required parts of NDA/BLA submissions as valuable tools for presenting and understanding the safety and efficacy of the product. Efficient and effective development of ISS and ISE involve...
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Tuesday, May 21, 2024 · 5:00 PM IDTWhen you think of a database lock, do you think of Data Management? Join us for a dynamic webinar exploring the intricate world of database lock processes and discover how Project Management plays a key role. You will learn proven PM strategies an...
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Tuesday, April 16, 2024 · 6:00 PM IDTDeveloping treatments for rare diseases pose many unique challenges that cannot be addressed by traditional study designs, including:
1) Prolonged enrolment periods and/or inability to enroll enough patients to formally power trials
2) Lack of c... -
Tuesday, February 6, 2024 · 10:00 AM KSTJoin Amanda Cross, Bioforum’s Chief Operating Officer, to learn how a data-first approach to outsourcing can speed your FDA submission timelines.
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Thursday, December 28, 2023 · 11:00 AM ISTThe webinar will be hosted in Hebrew
Join Limor Teomim and Ido Raz as they look at a strategic modernization approach to adapting computer system validation (CSV) to evolving technological landscapes define risks in software validation:
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Thursday, September 28, 2023 · 4:00 PM IDTJoin Sharon and Paul, Bioforum’s leading biostatisticians to discuss their experiences with the Risk-Based Quality Management (RBQM) and review of critical trial data. During the webinar we will demonstrate flexible strategies to support varying t...
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Wednesday, July 19, 2023 · 4:00 PM IDTHow to Get the Most From Your Medical Writing Vendor: An Open Discussion With Angela Burnett and Shiri Diskin
Medical Writing department heads from Bioforum and RRD International will discuss how to effectively select medical writing vendo... -
Tuesday, June 20, 2023 · 4:00 PM IDTJoin Tanya du Plessis and Tony Hewer as they look at an innovative approach to solving the mysteries of regulatory guidance around audit trail reviews:
• What do regulations (21 CFR Part 11) say about audit trail reviews?
• What’s the purpose on ... -
Wednesday, May 31, 2023 · 9:00 AM EDTJoin Tanya du Plessis and Bremer Louw as they a look at an innovative approach to solving two of the major challenges facing SDTM:
• How can you ensure all your clinical data end up in SDTM?
• How can you show an audit trail of your SDTM data tra...