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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