Patient Recruitment System

Number of electronic health records screened:

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Workshop: Demonstrating How to Implement Risk-Based Monitoring

EFGCP Workshop on Quality Risk Management in Clinical Trials: Demonstrating How to Implement Risk-Based Monitoring
16 & 17 June 2014
University College London, United Kingdom



The interactive workshop is intended to develop practical strategies and approaches for risk management and risk-based monitoring (RBM) in clinical trials. The workshop was developed in close collaboration with thought-leaders from health authorities, industry, CROs, academia and patients representatives. Up to now discussions on clinical risk management have been mainly theoretical and the practicalities of ‘how to’ have not been sufficiently addressed.


Randy Ramin-Wright, Head of Quality Risk Management at ii4sm will facilitate with Peter Schiemann of Widler & Schiemann the session:


Design Space & Key Risk Indicators (KRIs)


Participants will learn about:

  • What KRIs (Key Risk Indicators) are and what they are good for?
  • How KRIs are shaped by the design space stipulated in the protocol
  • How KRIs are designed - the principles and practical exercises
  • How to work with KRIs for Quality Management purposes - case study exercises
  • How to use KRIs to steer Risk Based Monitoring
  • How to validate KRI thresholds

Randy looks forward to meeting you at the workshop. To register or for more information: E-mail This email address is being protected from spambots. You need JavaScript enabled to view it. or visit Additional Workshop Information


ii4sm has become a member of the Alliance for Clinical Research Excellence and Safety (ACRES) Technology Consortium to create an IT platform using existing technologies to fast-track the development of an integrated interface for: sharing of professional credentials, site-capability profiles and demographics for site-qualification assessments; online performance dashboard; risk-based quality management analytics and support; and cloud-based tools for enhanced compliance, safety-reporting and monitoring.

For more information:

see ACRES press release


contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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Transforming Life Science Data into Value

ii4sm supports the life sciences industry and its navigation through the seas of information for fast but safe maneuvering from point to point - Changing Course for Efficiency and Compliance

ii4sm offers innovative software solutions for the life sciences industry. Our Quality Risk Radar Software facilitates quality by design, risk-based monitoring and vendor oversight during clinical development. The Patient Recruitment System finds eligible patients in electronic health records according to the study protocol eligibility criteria.

Further, we offer risk management consulting and outsourcing services, with a focus on improving the processes in clinical development.