Presentations

Outsourcing in Clinical Trials Nordics 2017: SDV in Risk Based Monitoring

Algorics’ CCO Rob Nichols joined Richard Davies, Executive Director Business Solutions, OmniComm Systems to review the changing practices around Source Data Verification (SDV). The presenters discussed the power of a fully automated approach to assessing site performance and in real time driving changes to onsite monitoring practice, including dramatic SDV reduction.

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.

On Demand Webcast: Risk Based Monitoring Adoption Simplified

Algorics’ CCO, Rob Nichols joins senior executives from DATATRAK to take on the topic of simplifying the adoption of Risk Based Monitoring (RBM). This on-demand webcast provides an overview of the regulatory backdrop for RBM and tips for successful implementation.