Risk based monitoring. It’s about the people.

June 17, 2018

It will come as no surprise to anyone who is actively involved in clinical trial operations that the heart of the matter in clinical trial monitoring is people.

I have written herehere and here about how people are the key assets and vulnerabilities in medical device clinical trials.

Understanding people and providing timely and high-quality communications rests is a key to data-driven decision making. There may be high value in the analysis of the data (for example – inconsistencies in dosing at sites) but if the data is not communicated in a timely and effective manner, risk based monitoring will not be effective or timely either!

MANA RBM risk based monitoring is a consultancy based in Denver CO, led by Penelope Manasco MD, that provides CRO and consulting services around risk-based monitoring. Dr. Manasco recently published an article  It Takes a Village to Achieve Risk-Based Monitoring that discusses the “people” components needed to successfully adopt Risk Based Monitoring. It also compares the roles of the Site Monitor and Central Monitor and discusses the role of risk assessment, training, and implementing Risk-Based monitoring solutions.

Good job!

There are sites who are outstanding, entering high quality data within 24 hours of the patient visit and then there are sites who take 2-3 weeks to enter data, enter future events and are not always careful regarding informed consent and participation in the trial.

This is a people issue not a technology issue.

Jenya Konikov-Rozenman is product lead at Flaskdata.io. Jenya has a masters degree in biotechnology from the Hebrew University and is a doctoral candidate at Tel Aviv in medical science. She is GCP and CRA certified and leads with super-human devotion to customer delivery.

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