CCS Associates to Provide Regulatory and Safety Support for I-SPY COVID-19 TRIAL

CCS Associates, Inc. (CCSA) is proud to announce their continued collaboration with Quantum Leap Healthcare Collaborative (QLHC) in support of the I-SPY Trials. In addition to its ongoing efforts on behalf of the I-SPY 2 TRIALTM for neoadjuvant treatment of locally advanced breast cancer, CCSA has been selected to be the Regulatory and Safety support contractor for the I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients. The goal of the study is to rapidly screen promising agents for treatment of critically ill COVID-19 patients, and to identify agents with potential for a substantial impact on reducing mortality and the need for, as well as duration of, mechanical ventilation in the setting of a master protocol.

QLHC’s I-SPY platform uses a master protocol to provide a regulatory framework in which multiple therapies can be assessed in a single study. CCSA provides support for regulatory and safety report generation and submission for the I-SPY 2 TRIAL master protocol and all of its affiliated protocols. With the I-SPY COVID TRIAL master protocol, CCSA will continue its exemplary efforts in providing reporting and submission services.

Dr. Beverly Smolich, the key project principal at CCSA, is excited for her team to be part of such a critical effort, particularly from its inception, and looks forward to helping the global research community fight the COVID-19 pandemic.

For additional details on the I-SPY COVID TRIAL please visit​

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