MONITORING & STUDY MANAGEMENT
Study management at RPM ensures a good interface with medical institutions and sponsor companies.
- Our certified Clinical Research Associates (CRAs) and Monitoring Leads (MLs) are well-trained and specialized in ICH GCP, protocols, operating procedures, and relevant knowledge.
- Project Manager takes the initiative in overseeing overall study conduct (scope, timeline, cost), as well as proactive issue-control
- Our project team also responds to decentralized clinical studies. RPM acts as an interface for the sponsor-investigator-CRO triangle, moving the project toward completion as expected.
RPM Monitoring Activities include (based on the scope of work);
Our clinical operation teams ensure the standardized but tactful monitoring services
- Feasibility survey, selection of medical institutions/investigators per protocol
- Explanation and agreement on study protocols
- Preparation of clinical trial contract with medical institution
- Study drug allocation/retrieval procedures
- Confirmation of protocol adherance
- Collect and check case report forms
- Direct access to study data
- Procedures for completion/termination of clinical trials