Medidata Talks RBM with ClinOps Toolkit for SCOPE2015 Conference

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Our First Interview in the GCP Series

Our 2015 ClinOps Toolkit video interview series introduces you to two of our favorite industry thought leaders and Good Clinical Professionals (GCPs)! Kyle Given and Barbara Elashoff of Medidata kindly agreed to sit down with us for an interview to discuss risk-based monitoring (RBM) and Barbara’s SCOPE 2015 presentation.


Medidata Talks RBM

Big data is being generated by everything around us at all times. Every digital process and social media exchange produces it, including clinical trials. Harnessing the power of big data analytics is the latest advancement in RBM. Barbara’s talk gave practical examples on implementing RBM and extolled the benefits of how all of this information can be used for RBM to improve data quality beyond what key risk indicators (KRIs) can provide.

Barbara, I understand that you have prior experience as a statistical reviewer for the FDA. Please tell us more about yourself.

Barbara: Yes, I was a Statistical Reviewer in the Department of Pulmonary Drug Products. While I was there we were still using paper case report forms (CRFs), and around that time electronic data capture (EDC) was starting. Companies were doing 100% source data verification with a lot of edit checks and we still had poor study data quality.

Kyle, I know that you have given talks at DIA about RBM. Will you introduce yourself as well?

Kyle: Thanks, Nadia. I’m Kyle Given, Principal in our strategic consulting team at Medidata. I head up our clinical services area, so I work across the operational space. I, like Barbara, am focused on Risk-Based Monitoring, one of our primary solutions for our customers.

At the ClinOps Toolkit we’re supremely interested in the topic of RBM because we support all additional oversight in clinical trials. How will we implement this?

Kyle: We’ve had a unique position at Medidata to work with so many of the customers using our products and helping them figure out some of these early hurdles. That’s why one of the reasons Barbara and the solution she brought to Medidata from Patient Profiles really help us work with customers to find those analytics and start looking at the data in a more meaningful way. We are using big data to define risks and we’re helping them eliminate some of the non-value added activities like source data verification in its 100% form.

Barbara: Medidata is at the forefront of improving data quality. We want to take RBM to the next level, and implement a process for Sponsors to get their studies set up quickly and to take action on the things they find in the data.

Disparate Data Is Ideal for RBM

How does the Patient Profiles tool address the problem of lots of data coming from lots of different sources?

Barbara: We can connect to Medidata Rave®, our EDC system, and also bring in data integrated from other sources including wearable devices, patient diaries, labs outside of Rave, and many others.

Medidata brings together all your data into one fully-customizable patient profile report.

Medidata brings together all your data into one fully-customizable patient profile report.

What kind of sample size are we talking about? Do we have to have hundreds of thousands of patients in our database or is your program effective in all types of studies?

Barbara: Our program is effective in all types of studies from Phase II studies on. Phase I studies are a little too small. We need about 30-50 patients to find patterns. We can find them when a site has only one patient enrolled as long as there are enough patients in the other sites to compare patients to.

medidata patient profiles show disparate clusters of dataIf the site is an outlier in the context to another site or a patient is an outlier within a site, then sponsors and CRAs can intervene earlier in the process. That could actually have a profound operational impact on the trial if you can catch those signals.

Do Monitors Need RBM Training?

What do you see as the most important skills for the new monitor under the RBM methodology?

Kyle: I think they’re going to appreciate that they’re going to use skillsets that they haven’t been able to use in the more traditional, administrative heads-down monitoring mode. Good interpersonal skills are needed to articulate the problems and then provide really constructive ways to help sites improve the quality of their work. I think that’s ultimately what we want monitors doing and know that’s where they can really help sites over the current model.

monitors can go to a site and discuss data quality through medidata patient profiles

Barbara: Having the data is a way to start the conversation with a site to show them how they’re doing something differently.  Monitors will be able to partner more easily with their sites. When they have the data to have a framework around the conversation, they can actually better help the sites protect patient safety and protect the integrity of the data going to the endpoints as well.

ClinOps Toolkit GCP’s Final Thoughts

Any parting words about RBM for the ClinOps Toolkit audience?

Barbara: If you’re just doing 100% source data verification with your head down, you can only see the data at that small level as opposed to the big picture. So I would say I would be nervous if you’re not doing RBM.

Kyle: Embrace RBM. It is here to stay.

Quick-Fire ClinOps Toolkit Questions

What’s the best advice you‘ve ever received?

Kyle: One of my mentors early on told me some important advice: “You know you are being disruptive and productive when others are getting upset. It is okay to change and innovate if it leads to working smarter and more efficiently.

Barbara: When I was first working on my software I was initially flooding the user with too many graphs and I received the advice, “Too much information is worse than no information at all. Pare down your message and only show the most important problems and trends.”

What is one mistake, habit, or pattern we should improve in our industry?

Kyle: We have monitored sites but I think we need to stop monitoring and help them set up processes to be operationally successful instead.

Okay—in 10 words or less, what is the single most interesting thing happening in our industry?

Kyle: Mobile health data: increased visibility to medication compliance between visits.

We appreciate your comments and fantastic advice. Thank you so much for the first ClinOps Toolkit Good Clinical Professionals video interview!

Do you have more Medidata RBM questions?

At the ClinOps Toolkit community we want to foster conversations that help our audience discover efficiencies in clinical trials. When it comes to effective trial management and connecting clinical trial professionals through educational info-sharing, Medidata is a true industry leader. Be sure to check out the Medidata thought leadership blog, Geeks Talk Clinical.

20130814 Final Medidata Logotype

If you have any follow-up questions to Barbara’s talk at SCOPE or any general RBM questions for our guests, please leave us a comment below.

Thanks for following along! Check out more video interviews of Good Clinical Pros at the ClinOps Toolkit YouTube channel.

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Barbara Elashoff
Medidata_Barbara HeadshotProduct Manager, Risk-Based Monitoring, Medidata

Barbara Elashoff is the product manager for risk-based monitoring at Medidata Solutions. Prior to her current role, she was the founder and CEO of Patient Profiles, LLC, which was recently acquired by Medidata. Barbara has extensive experience in regulatory services and products focused on the design and analysis of clinical trials and diagnostic studies. She was also a statistical reviewer at the FDA in the Division of Pulmonary and Allergy Drug Products division. Barbara received her MS in biostatistics from Harvard University.

Kyle Given
Medidata_Kyle HeadshotPrincipal, Risk-Based Monitoring, Medidata

As strategic consulting services principal at Medidata, Kyle is responsible for the Risk-Based Monitoring consulting practice. With over 20 years in clinical research, Kyle is a recognized expert in operational efficiency models including risk-based monitoring.

Prior to joining Medidata, Kyle was executive vice president at Research Pharmaceutical Services (RPS). During his tenure, he worked alongside leading large and mid-sized pharmaceutical companies to design, implement and enhance global site management and monitoring organizations through processes, technologies and advanced business analytics. Prior to RPS, Kyle led the US clinical research operational team at Sanofi.

About The Author


Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.

1 Comment

  • Jacki

    April 10, 2015

    RBM question: what sector is initiating and encouraging RBM, and what are sponsors’ reactions to it?

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