White papers

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

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.