Our Integrated Approach

MCRA's clinical study project team will work closely with the sponsor project team to determine what the best approach to starting the study is. After carefully reviewing all applicable documents provided by the sponsor, MCRA will develop a plan to effectively start the study. MCRA will develop or review the study protocol and case report forms to allow for a full understanding of the study design. 

MCRA's CRO supports the development of the following study materials: case report forms (CRFs), source documents, study logs, patient binders, informed consent forms, the investigator brochure, the monitoring plan, the Trial Master File (TMF), and the monitor and site training materials. MCRA will also work closely with the sites, guiding them through the study set up activities including essential document collection and GCP training.

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Abigail Allen

Abigail Allen

Senior Director, Clinical Affairs