ITCT 2017: Tools and Processes for Data Driven Monitoring and a Risk Based Approach
Algorics’ CCO Rob Nichols joined Mark Paul, Senior Vice President, CROS NT to present how clinical trial professionals can harness the power of data visualization and statistics to enhance the collaboration between clinical operations, data management and biostatistics. The presenters also provide an overview of technology solutions to enable a risk based approach in accordance with the guidelines set out in the new ICH GCP E6 (R2) Addendum.
Trials, Tech and Transformation 2017: Adopting Risk Based Approaches to Monitoring
Algorics’ VP Clinical Solutions Abby Abraham joined Brian Sweeney, Director Strategic Accounts, MedNet Solutions to present two complementing case studies on Adopting Risk Based Approaches to Monitoring:
• We share our experience through a blended case study
• Risk planning and mitigation – How do we do it?
• Data driven monitoring – Does it work?
• Risk based scoring – Is it close to reality?
• Understand success factors and challenges during implementation.
SCOPE Summit 2017: Risk planning & mitigation - Overcoming traditional mindsets
Risk planning is the corner stone for the successful conduct of clinical trials. Algorics has collaborated with a CRO to apply risk planning and wider risk based monitoring (RBM) principles on a study. The case study focuses on the risk planning framework, systematic methodology adopted, and advantages gained from implementing new technology. Experiences drawn from cross-functional collaboration, development of a holistic Integrated quality and risk management plan (IQRMP) and creation of risk indicators is discussed.
SCDM 2016: Successful Implementation of Risk Based Monitoring – What is Needed in Clinical Data Operations Today?
Algorics’ Abby Abraham chaired a session at the recent SCDM event in San Diego, including RBM experts and industry colleagues from Roche, Quintiles & MedNet Solutions. In this presentation, Abby reviews the evolution of RBM and explores the technology integration required to ensure efficient and scalable operational delivery and adaptions to changes associated with RBM adoption.
Acuity Data Visualizations feature in SQA Annual Meeting
Michelle Holbrook Thompson from FDA Quality and Regulatory Consultants (FDAQRC) presented an educational poster titled, ‘Stack, Swarm, Arc oh My! – The Power of Data Visualizations’ featuring visualizations created in Algorics’ Acuity.