Professional management of study sites is essential to the success of a clinical trial. Modoc retains an established group of experienced clinical research professionals who serve as Clinical Study Managers (CSMs). Modoc SMs are the critical links between the client sponsors and the investigator/sites, providing full support from study initiation to closure. Through integration of the CSM team expertise, we are able to help our clients achieve their successful study goals most efficiently and affordably.
Our Clnical Study Management services cover several important areas.
- Preparation of an extensive study management plan
- Study/site feasibility studies
- Site contract and budget negotiation and management, including invoice reconciliation
- Site Initiations/Investigator Meetings
- Coordination and management of laboratory samples, courier and reports
- Investigational product management: oversight of packaging/labeling and distribution vendor
- Coordination of clinical monitoring activities
- Outsourcing Management
- Oversight and management of service providers including CRO, independent contractors and central laboratories
- Ensure adherence to study milestones and timeline for each service provider
- Development of essential study documents and associated training
- Quality Assurance
- Audit monitoring activities to ensure quality monitoring and adherence to sponsor SOPs
- Audit preparation (sponsor and FDA) and follow-up