Cystic fibrosis research goes electronic

Cystic Fibrosis Foundation deploys Medidata Solutions’ Rave platform to manage clinical data, increase efficiency

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NEW YORK—Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation, has selected Medidata Solutions' Rave data capture and management platform to process clinical data for its cystic fibrosis clinical research, the organizations announced last month. Medidata Rave will be used at CFFT's Therapeutics Development Network Coordinating Center, a research program of Seattle Children's Research Institute.

Medidata's Rave platform integrates electronic data capture (EDC) with clinical data management (CDM) and reporting and will be utilized in several upcoming cystic fibrosis clinical research trials across Phases I through III, as well as epidemiological studies, starting this month.

The focus of CFFT's Therapeutics Development Network Coordinating Center is to facilitate safe, rapid and coordinated evaluation of new treatments for cystic fibrosis.

The center is based at Seattle Children's Research Institute, which focuses on pediatric research aimed at improving the health and well being for people of all ages. The center facilitates approximately 20 clinical trials yearly and is responsible for several critical discoveries in cystic fibrosis treatments. The center handles data management for a number of these studies each year.
Until recently, the coordinating center had outsourced its CDM systems to several contract research organizations. With the ongoing expansion of the clinical trials network and the growing number of cystic fibrosis clinical protocols, the center decided to bring more of its CDM operations in-house in an effort in increase efficiency and lower costs.

In performing its due diligence over the course of a 10-month period, the data management team evaluated five EDC and CDM solutions and selected Medidata Rave. Facilitating both academic and private industry trials, the coordinating center's decision was influenced by Medidata's ability to adapt to a range of clinical requirements and the company's focus on building strong relationships with its customers—not only as a service provider, but as a true research partner, said Ilonka E. Evans, manager of Biostatistics and Clinical Data Management at CFFT's Therapeutics Development Network Coordinating Center, in a statement.
By implementing Medidata Rave, the coordinating center expects to offer a more cost-effective solution to conducting clinical research, Evans added.
"With a strong customer focus, the Medidata team demonstrated that they understand the unique challenges we face operating in both academic and private industry environments," Evans stated. "Because it will enable our research sponsors to access and manage trial data more efficiently and reduce costs, Medidata Rave will be critical to the success of our upcoming cystic fibrosis research."

According to a press release from the center, standardized and reusable electronic case report forms and edit checks across multiple studies will increase efficiency and generate significant cost savings by allowing CFFT to conduct more studies using the same resources.

The center added that implementing Medidata Rave will also decrease time dedicated to study startup, data cleaning and study closeout. In addition, trial managers and monitors will have quick access to research data with the use of Rave, the center added.

Medidata declined to be interviewed for this story. CEO Tarek Sharif said in a statement that the company is looking forward to Medidata Rave's use in facilitating the cystic fibrosis studies, as over the years, CFFT and Seattle Children's Research Institute have achieved significant clinical breakthroughs.

"Our expertise in this therapeutic area, experience working with leading academic institutions and ability to quickly implement and train researchers on Medidata Rave will be instrumental in helping the cystic fibrosis clinical trials network achieve improvements in its trial efficiencies," Sherif stated.

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