Testimonials

Boehringer Ingelheim
"Shafi Consultancy did some very complex and important data transformations for us for high profile multiple trials..."
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F. Hoffmann-La Roche
"Shafi Consultancy analysed a very large and complex database for us... "
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PharmaProjekthaus
"...responding to FDA questions at short notice under extremely short timelines, Shafi Consultancy has helped our client ... meet all their timelines..."
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IMS Health
"Shafi Consultancy supported us with essential data transformations and analyses that ensured we met our project timelines...."
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PRMA Consulting
"Shafi ran a bespoke SAS training session for a small group of us to...."
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Risk-Based Monitoring

Established risk-based monitoring application with...

...a proven track record.

Risk-based monitoring has been a key part of the clinical trial process for many years. However, it was not until August 2011 when EMA released their Reflection Paper and later FDA released their Guidance on Risk-Based Approach that this approach began to be widely adopted by the larger Pharmaceutical Organisations. The aim of risk-based monitoring was to improve the quality of the study data, and it was suggested that this might be better achieved by spending more resource on sites with lower quality data than by checking 100% data from all sites. Our Cent-RBM application has been designed specifically with this in mind.

As a pioneer in risk-based monitoring, we developed a web application in 2011 that allowed Central Monitors of a study to specify in the Monitoring Manual what should be monitored, how and when. By reviewing only a minimum amount of monitoring tasks as a starting point for each site, that could be increased and later decreased depending on the quality of the data from that site, the study team were able to allocate resources where it was most helpful. This not only raised the quality of the data as programs continuously checked the study database for fraud detection, safety monitoring, event monitoring, standard Source Data Validation (SDV), Source Data Review (SDR) and Unreported Event Monitoring (UER), it also significantly reduced the cost of monitoring.

Our experience and feedback over the years from maintaining risk-based monitoring applications for mega trials in over 70 countries and thousands of users has led us to develop our most intuitive application to date. Central Monitors can not only communicate with the CRAs and CMLs, they can also see straight away the sites that need attention, when visits should be performed, the visit reports, and how the sites have changed over time. The CRAs can submit their visit reports within the system that is then approved by the CML, and everyone can review the data used to assign risk score by reviewing the score report in logical groupings such as fraud detection and compliance.

All monitoring tasks are automatically assigned by the system based on the risk score of each site, and all activities are monitored by the Central Monitor to ensure the highest quality of monitoring is performed throughout the study. Analytics of the monitoring activities are key to ensuring successful monitoring and the best quality of data in the study database. This system not only brings everything to your fingertips, it allows you to see what is coming up and the impact of any interception immediately.

Benefits

  • Raise Quality of data by intelligent monitoring
  • Significantly reduce the effort and cost of monitoring
  • Continuous Data Quality Oversight using the ongoing trial database
  • Adapt monitoring requiements during trial conduct
  • One system for all monitoring taks, including visit reports
  • Seemeless communication within the systembetween Central Monitors and CRAs
  • Intuitive and easy to use with built-in training

Key Functions

  • Follows the process defined by TRANSCELERATE
  • Graphical interface to easily review, update & interpret data
  • Risk assessment, visit schedules and monitoring tasks are automaticaly derived for each site
  • Calculates risk of each site
  • Focuses monitoring resources to where it is required
  • CRAs can complete and maintain all monitoring reports within the system
  • Central Monitors and CRAs can review and update all monitoring activities from a single system

Contact us for a demonstration