Take the Pain Out of Data Safety Monitoring Boards (DSMBs)

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 organising 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, featured speakers 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:

• A bespoke approach to biostatistics, clinical data management and statistical programming to handle all DSMB requirements
• Pinpointing and targeting the data required based on the principles of patient safety and data quality
• Potential automations to bring efficiencies
• Close collaboration to work faster and easier – ensuring the success of the DSMB

Register for this 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.

Speakers

Liam Sheehan, Project Delivery Manager, Statistical Programming, Quanticate

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.

Message Presenter

Claude Price, Director, Clinical Data Management, Quanticate

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.

Message Presenter