Having problems with too many Protocol Amendments? Then our Study Quality Management (SQM) Pilot Project is for you, as it enables you to:

  • Pilot a risk-based approach to Study Quality Management
  • Pilot SQM Technology
  • Gain experience with the approach and the technology
  • Make an informed decision about how to proceed

For further details, download Pilot Project Description - Study Quality Management.
For further information regarding how to get started, go to Getting Started.

Clinical operations is regularly confronted with and challenged by executing clinical trials globally, implementing poorly designed study protocols within complicated processes using a multitude of vendors and collaborating with investigator sites with disparate experience levels and fluctuating clinical resources. Under these conditions, Sponsors are accountable for complying with country regulations, ensuring patient safety as well as study data quality. These challenges are formidable and as such can be daunting and lead to study quality degradation.

Clinerion's risk assessment application, Study Quality Management, enables clinical operations organizations to take a risk-based approach to Study Quality Management. It delivers significant business value by:

  • Shortening the average time to study dossier submission by minimizing the number of study protocol amendments by informing the study protocol design team of quality risks prior to protocol approval
  • Lowering operational costs by controlling risk with responses that are commensurate with the calculated risk level

This is achieved by the application of a standard set of industry-tested risk metrics. The risk calculation engine underlying all of the risk assessment applications computes an overall risk score for each risk entity that is based on structural and operational risk factors. This way, the true risk exposure of a study protocol or trial site is assessed.