Data Safety Monitoring Boards (DSMBs) need to be conducted under demanding time constraints. Therefore, preparing for them can be a fraught and challenging experience; having to juggle all of the ongoing activities of a study in full-swing with the additional workload of writing charters, finding extra resources, and even board members organizing and scheduling the meetings themselves isn’t easy. All of this extra work sometimes feels like it can limit the time spent doing a thorough data review, especially if it involves wading through 1,000s of pages of data listings.
In this webinar, Quanticate will explain how to overcome these problems and how a team structured approach to DSMBs can save time and reduce stress.
Key discussion topics will include:
Watch this on-demand webinar to learn how to provide the outputs and summarise data in such a way so that clinicians don’t need to overthink their interpretations, letting them focus on the safety of the patients in their study.
Claude Price has over 18 years’ experience within clinical research, covering roles in both Clinical Data Management (CDM) and Project Management. The majority of this time has been spent in CDM at various CROs, both large and small. Claude has been responsible for overseeing large portfolios and managing Data Management groups, whilst working across numerous therapeutic areas and study phases.
Liam has been with Quanticate since 2011 and has worked on a range of clinical trials across Phases I-IV, as both a lead statistical programmer and as a lead statistician. He has been responsible for the production and QC of datasets, tables, listings and figures, sample size calculations, randomisations, and has written and QC-checked SAPs and Statistical Reports. This has given Liam the experience to project-manage the Statistics and Programming department to ensure the deliverables are on time and to the highest quality. Liam holds a BSc (Hons), Mathematics and an MSc with Distinction, Statistics with Applications in Medicine.
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