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Introducing the most advanced simulation-enabled tools for
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Correcting Site Enrollment In 3 Steps

Correcting Site Enrollment In 3 Steps

Patient enrollment is a common subject of discussion among both sponsors and research sites. Challenges to enrollment can be myriad, and the root causes are hard to pin down. But effective enrollment is critical to the ultimate success of any clinical trial, and there...

Reducing Protocol Deviations With Training-Based Metrics

Reducing Protocol Deviations With Training-Based Metrics

Protocol deviations can have a detrimental effect on new drug development, adding to costs and time to clinical trials and even putting the acceptability of data generated during a study at risk. Despite this, protocol deviations seem to be viewed as just part of...

Telling Ain’t Training

Telling Ain’t Training

Whether ensuring GCP compliance or the correct application of a study protocol, training is a critical part of any clinical trial. During the life of a study, there may be several points at which a sponsor may require additional or more intensive training to...

SIVs: Identify Skill Gaps Before Retraining

SIVs: Identify Skill Gaps Before Retraining

As a former CRA, I have spent the better part of my career mentoring, teaching, and helping CRAs become competent at monitoring clinical trials to ensure compliance with protocol and GCP. In light of this experience, I urge all CRAs and monitors to STOP THE MADNESS of...

Preventing Protocol Deviations With Simulation-Based Training

Preventing Protocol Deviations With Simulation-Based Training

Protocol deviations can have a devastating impact on the quality and integrity of key study data and potentially affect patient safety. And there can be serious regulatory repercussions for failing to follow the protocol precisely, as well. Taking the right approach...

Maximizing Site Enrollment with Improved Protocol Comprehension

Maximizing Site Enrollment with Improved Protocol Comprehension

Sponsors and CROs trying to achieve better enrollment in clinical trials often overlook the most essential stakeholder in the process -- the investigative sites that implement the trials and interact with the patients throughout the process. At any given moment, tens...

Behavior Should Drive Clinical Trial Training, Not Test Scores

Behavior Should Drive Clinical Trial Training, Not Test Scores

Behavior Should Drive Clinical Trial Training, Not Test Scores Applying analytics that focus heavily on measuring changes to research staff behavior during training can be a strong predictor of performance during an active clinical trial, leading to better protocol...

The Fallacy of Footnotes Within Clinical Protocols

The Fallacy of Footnotes Within Clinical Protocols

As part of our series covering all the do's and don'ts surrounding protocols, I wanted to call attention to one of the greatest urban legends in clinical research...the requirement to include endless footnotes (in size 6 or 8 font no less!), at the end of the schedule...

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