During the “Risk Based Trial Monitoring: A Technology Amplified Approach” webcast, attendees submitted a few questions related to our proprietary TEMPO eClinical platform.  As a proprietary cloud-based application, TEMPO™ serves as the technology foundation to all of Clinipace’s clinical development service delivery teams.

Several of my colleagues assisted in sharing their insight and providing answers to the questions below.  If you’d like to view the recorded webcast, please visit: http://ow.ly/iWtgV. 

We currently use eCRF and review the query quality, e.g., top 10 queries, then analyze the reason behind it. How is your trigger system different or better than how we currently conduct our review? 

Trigger thresholds are customized for each study.  As part of an overall risk based approach, adaptive monitoring practices involve the use of real-time data to initiate a site visit when it is justified by on-site workload, quality signals and risk signals. A risk based approach utilizes alerts, triggers and predictive clinical data enabled by technology to make proactive decisions about the quality and status of on-going studies.

The adaptive approach (once risks have been assessed) is clearly outlined within your Quality Plan, Project Plans, Data Plans, Monitoring Plan and Risk Plans.  All plans must support one another, and the inter-relationship of these plans provides an algorithmic approach to risk based monitoring.

I assume Clinipace has a technology to allow effective risk based monitoring.  Is your technology compatible with commonly used eCRFs, e.g, meta data?  Can it extract data from an eCRF and build alerts, etc? 

Yes, Clinipace can work from other EDC data streams within TEMPO™ Trial Manager to create a risk based monitoring approach.  However, there are some drawbacks when the TEMPO platform does not directly house the EDC, Trial Manager, Data, electronic Trial Master File (eTMF), etc.

Risk-based monitoring requires real-time data assessment for maximum efficiency.  Data streams from other sources may experience a time lapse, full data exports can be difficult and there can be a lack of confidence in the ability to provide a full audit trial.

Do you have any success stories around getting remote access to sites’ electronic medical record systems to really facilitate remote source data verification?

The use of sites’ electronic medical record system is a tremendous opportunity and sets the stage for the “next frontier”.  The health industry needs to standardize electronic medical records (EMRs) so data can be assessed efficiently.  Leveraging risk-based monitoring across a single platform system and using an EMR system will revolutionize today’s traditional approach.

In your “single system”, what platform are you using? Is it an internally developed system or commercially available system?  How does Clinipace define trigger thresholds? Defined by Statisticians? Clinicians? Other?  Shouldn’t QA’s role be to review RBM monitoring plan, and advise clinops on appropriateness?

Clinipace’s proprietary TEMPO™ eClinical platform allows for more ease in the creation of trigger thresholds, which are customized for each study.  The Project Plans take on an even more important role in risk-based monitoring as multiple functional groups must be part of establishing trigger thresholds.  Functional groups include:  Study Start-Up Services, Monitoring, Quality, Data, Medical, Biostatics, and Project Management.  This begins at study start-up (with feasibility and site activation) and continues through the monitoring phase (with quality signals to many queries and high/low enrolling sites) and ends after study closure when the completed study file is transferred.