Cystic Fibrosis Foundation Therapeutics Implements Medidata Rave

February 18, 2009

Company News Release

Cystic Fibrosis Foundation Therapeutics Implements Medidata
 Rave at Coordinating Center for Clinical Research

Medidata Solutions Selected for Track Record of Creating Increased Efficiencies and Cost Savings in Academic Studies


NEW YORK.-February 18, 2009-Medidata Solutions, a leading global provider of hosted clinical development solutions, today announced that the CFFT Therapeutics Development Network (CFFT TDN) Coordinating Center, a research program of Seattle Children’s Research Institute, has selected Medidata Rave to manage clinical data for its cystic fibrosis clinical research. Medidata Rave’s comprehensive, robust platform that integrates electronic data capture (EDC) with clinical data management (CDM) and reporting will be utilized in several upcoming cystic fibrosis clinical research trials across Phases I–III, as well as epidemiological studies, starting in April 2009.

The CFFT TDN is a nationwide clinical trials network sponsored by Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) for the purpose of facilitating safe, rapid and coordinated evaluation of new treatments for cystic fibrosis. The Coordinating Center for the network is based at Seattle Children’s Research Institute, a leader in pediatric research aimed at improving the health and well being for people of all ages. The network facilitates approximately 20 clinical trials yearly and is responsible for several critical discoveries in cystic fibrosis treatments. The Coordinating Center handles data management for a number of these studies each year.
 
Until recently, the Coordinating Center outsourced its CDM systems to various contract research organizations (CROs). Due to the expansion of the clinical trials network and the growing number of cystic fibrosis clinical protocols, the Coordinating Center decided to bring more of its CDM operations in-house to increase efficiency and lower costs. Over 10 months, 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 heavily 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.
 
“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,” said Ilonka E. Evans, Manager of Biostatistics and Clinical Data Management at the CFFT TDN Coordinating Center. “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.”
 
With the implementation of Medidata Rave, the Coordinating Center expects to offer a more cost-effective solution to conducting clinical research. Standardized and reusable electronic case report forms (eCRFs) and edit checks across multiple studies will increase efficiency and generate significant cost savings by allowing the CFFT TDN to conduct more studies using the same resources. Implementing Medidata Rave will also decrease time dedicated to study startup, data cleaning and study closeout. Additionally, with Medidata Rave’s online monitoring capabilities, trial managers and monitors will have instantaneous access to research data.
 
“Over the years, the CFFT TDN and Seattle Children’s Research Institute have achieved significant clinical breakthroughs, and we are proud that Medidata Rave has been selected as the EDC and CDM solution that will help facilitate these cystic fibrosis studies,” said Tarek Sherif, CEO of Medidata Solutions. “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.”
 
About the CFFT Therapeutics Development Network Coordinating Center
Established in 2000, Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) is the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation. The Therapeutics Development Network (TDN), funded by CFFT, is a nationwide network of cystic fibrosis clinical research centers. These centers specialize in conducting clinical trials to evaluate the safety and effectiveness of new CF therapies. The CFFT TDN Coordinating Center, which is part of Seattle Children’s Research Institute, supports and facilitates the activities of the network. For more information visit: http://www.cff.org/research/CFFT/TDN/.
 
About Seattle Children's Research Institute
At the forefront of pediatric medical research, Seattle Children's Research Institute has nine major centers, and is internationally recognized for advancing discoveries in cancer, genetics, immunology, pathology, infectious disease, injury prevention and bioethics. In its quest to cure childhood disease, the research institute brings discoveries to the bedside in partnership with Seattle Children's Hospital and Seattle Children's Hospital Foundation. Together they are Seattle Children's, known for setting new standards in superior patient care for more than 100 years. Children's serves as the primary teaching, clinical and research site for the Department of Pediatrics at the University of Washington School of Medicine, which consistently ranks as one of the best pediatric departments in the country. For more information visit: http://research.seattlechildrens.org/.
 
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of hosted clinical development solutions that enhance the efficiency of customers’ clinical development processes and optimize their research and development investments. Medidata products and services allow customers to achieve clinical results more efficiently and effectively by streamlining the design, planning and management of key aspects of the clinical development process, including protocol development (Medidata Designer), investigator benchmarking and budgeting (Medidata Grants Manager), contract research organization (CRO) benchmarking and budgeting (Medidata CRO Contractor), and the capture, management, analysis and reporting of clinical trial data (Medidata Rave). Medidata’s diverse customer base spans pharmaceutical, biotechnology and medical device companies, academic institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies.

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