Study Start-up
Clinsite Start-Up Teams deliver a coordinated, collaborative, and tailored approach that accelerates site initiation and supports every phase of global clinical trials. Working alongside top therapeutic and regulatory experts, our experienced and dedicated team engages quickly, applies strategic insights, and ensures faster start-up timelines than industry standards.
Clinical Monitoring Oversight
Our monitoring services include comprehensive monitoring plans, support for 100% source document verification or risk-based monitoring strategies, identifying and escalating adverse event (AE) issues, routine monitoring, site initiation, interim, and close-out visits, and on-going formal training programs. We operate via local CRAs in each of the countries to ensure that our clients have immediate access to local knowledge, under robust, centralized SOPs.
Our CRAs conduct on-site monitoring visits throughout the study to
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients
