Our client, a US based translational neurosciences company, were to conduct a medical device clinical trial on patients with Persistent Post-Concussive Symptoms (PPCS) after Traumatic Brain Injury (TBI). They needed full service clinical trial operations and strategy support for the design and execution, including:

• Development of study protocol and strategy
• Selection and management of multiple US-based trial sites
• Database setup and creation of study documents
• Clinical Monitoring and Regulatory Support
• Data Management and Statistical Analysis

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