By Clinical Informatics News Staff 

 

December 11, 2014 | In late October, Medidata acquired Patient Profiles, an early-stage software company focused on improving clinical trial data quality. Today the company has announced an enriched solution for risk-based monitoring (RBM) of clinical trials using the Patient Profiles technology. 

 

Medidata’s risk-based monitoring offerings date back about three years, Kyle Given, Principal, Strategic Consulting Services, Medidata Solutions, told Clinical Informatics News. The Patient Profiles solution is, “rounding out” the RBM toolkit, he said: “Not just the ability to do targeted monitoring and look at operational risks, but really more importantly now to expand by including the ability to look at the clinical data and define statistical anomalies in the data that you might not be able to detect through standard operations.” 

 

Last February, speaking at the Summit for Clinical Ops Executives, Barbara Elashoff, CEO of Patient Profiles, challenged the audience to find study data errors before the end of the study. Patient Profiles’ Query Map tool is automated error monitoring, with the rules being inferred from the data itself. The approach offers the best in user experience and data management, she said.

 

Elashoff now serves as Product Manager for risk-based monitoring at Medidata, and Patient Profiles is now available as a consulting service to Medidata customers. 

 

Patient Profiles will be integrated into the Medidata Clinical Cloud as part of Medidata RBM. Through the automated review of clinical data captured in Medidata’s cloud-based electronic data capture and management system, Medidata Rave, the addition of Patient Profiles makes Medidata RBM the first cloud-based solution to provide centralized monitoring analytics using both operational data (e.g., key risk indicators, such as adverse event rates and query cycle times) and patient data, the company said. 

 

Patient Profiles has two major outputs, Given explained. The Patient Profiles themselves are consolidated summaries of patient data with the ability to highlight data that’s clinically relevant. The Query Map tool is centralized statistical monitoring that produces visualizations that display all of the data in a series of scatterplots or other visualizations highlighting those data that are anomalous. Both types of reports will be available to customers. 

 

For now, the design of the Patient Profiles queries is offered to Medidata clients as a service, but Given says the company is building and plans to launch a cloud-based product in the future. 

 

Finding adverse event data or flagging anomalous data that could signal an adverse event is one of the most important tasks of monitors today, Given said. The next big task is identifying fraud and misconduct—finding data that is “too normal.” Patient Profiles and Query Map address both of these tasks well, he said.  

 

Customers often feel that setting up RBM is a rather daunting task, Given said, but he emphasized that RBM can be implemented in a modular way. 

 

“Sometimes, I think, customers think they have to get to the final value of RBM and that may take some time. But just to get started, it’s actually pretty easy. Taking small bites of RBM is probably the best recommendation,” Given said. “Patient Profiles as a product is really great at looking at risks. To me, any clinical study should be looking at risks in their clinical data and that may be one stepping stone toward a full RBM deployment.” 

 

Editor's Note: Medidata will be among the companies represented at SCOPE 2015, February 24-26, Orlando, Fla. in the track: From QbD & Risk Assessment to Risk-Based Monitoring. More information on SCOPE and registration details are available at www.scopesummit.com