A solution-oriented and structured Clinical Research Manager (CRMs) will be assigned to your study and will coordinate all activities, from study start to the end. Our CRMs have experience of first-in-human/proof-of-concept studies as well as phase II and multi-centre studies.
- Single point of contact for the entire study team
- Close collaboration with all involved functions, ensuring high quality deliverables within agreed timelines and budget
- Regular study team meetings to ensure that all parties are well-informed throughout the study
- Pro-active risk assessment and management
- Development of project plans and timelines
- Issue escalation
- Site contract and negotiation
- Subject information and informed consent forms
- Regulatory submissions
- Investigator and CRA meetings
- Internal Safety Committee Review meeting management
- Vendor management
- Clean file and study closure activities
