Understanding the new ICH-GCP Landscape
In this white paper, Algorics’ VP Clinical Solutions Abby Abraham explores the latest ICH GCP revision and questions whether organizations can implement today’s regulatory requirements using conventional approaches. Whilst industry stakeholders are coming to terms with these new requirements, organizations utilizing traditional models of clinical research conduct and monitoring are in different stages of process gap identification and solution planning to become ICH-E6 (R2) compliant. Understandably, there are challenges to building or modifying processes and methodologies on the existing clinical execution model, which addressed ICH-GCP requirements when the last amendment was implemented more than 20 years ago. Abby Abraham reviews the important aspects to consider while implementing ICH-E6 (R2) and asserts that industry needs to seize this opportunity to transform.
Enriched Execution of Risk Based Monitoring by Leveraging Different Data Sources
Experts from Algorics and DATATRAK discuss how Risk Based Monitoring (RBM) needs to include components related to operational and logistical components that have impact on the risk planning and monitoring framework of a clinical study. Find out more about how best of breed technologies can support scalable compliance to the latest ICH-E6 requirements in a cost-effective manner.
Practical approach using an RBM framework to develop site risk profiles
In this case study Algorics’ Abby Abraham examines a practical approach using an RBM framework to develop site risk profiles.
Risk based monitoring (RBM) has been a widely discussed topic in clinical research in recent years but currently there is limited literature providing examples of practical application of techniques, in particular where an organization has limited resources for implementation of new approaches to trial oversight. The biopharma industry currently relies on extensive feet-on-the-ground monitoring to provide an assessment of site risk.
This exploratory case study illustrates how RBM can be applied using Acuity, and examines both data-driven models and centralized manual data review.
Is Risk Based Monitoring (RBM) an opportunity or challenge for mid-size CROs?
In this paper, Algorics experts look at the barriers that have slowed RBM adoption and outline some of the functional changes that need to occur to refine the operational model to an organization’s specific needs and culture. This white paper will support those currently developing their RBM adoption roadmaps.
Site monitoring - Transformed forever?
Algorics’ VP Clinical Solutions, Abby Abraham, discusses the realignment of processes and roles, and adoption of software technologies that require serious consideration when organizations consider implementing RBM.
Executing Risk Based Monitoring - Is it really technology enabled?
Abby Abraham, Algorics’ VP Clinical Solutions, explores the role of technology in RBM and asserts that ,”Process must precede people and technology requirements in RBM. It is imperative to address technology alignment to enable the process of executing RBM”.