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 PresenterWho Should Attend?
- Clinical Trial Managers
- Clinical Project Managers
- Clinical Study Managers
- Heads of Clinical Operations
- Senior Clinicians
- Principle Investigators
- Clinical Safety Officers
- Principal Statisticians
- Portfolio Delivery Managers
- Senior Research Associates
- Principle Programmers
- Heads of Programming
- Heads of Statistics
What You Will Learn
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
Xtalks Partner
Quanticate
Quanticate, headquartered in the UK and USA, is a leading global Clinical Research Organization (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As The Clinical Data Experts, our team provides high-quality, efficient outsourcing solutions for companies who need additional capacity or who want to outsource certain activities in their entirety.
Our clinical and post-marketing services include scalable on-site and off-site clinical data management, biostatistics, clinical programming, PK/PD analysis, medical writing, pharmacovigilance and consultancy. Quanticate was announced a five-category winner in the annual CRO Leadership Awards for Quality, Reliability, Productivity, Regulatory and Innovation. Quanticate was the first CRO to introduce the Centralized Service Provision (CSP) approach to outsourcing supported by its data centralization and visualization tool for both single study and cross-study data analysis.
Please visit the website at www.quanticate.com for further information and access to white papers.
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