Project Management

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

Clinical Trial Administration

Our dedicated Clinical Trial Assistants (CTAs) will work in close collaboration with all project team members and with each Sponsor to ensure the Trial Master File (TMF) is up-to-date and inspection ready. 

• Investigator Site File (ISF) set-up 
• Trial Master File (TMF) set-up, paper or electronic 
• (e)TMF management and quality control 
• Support to CRM and CRA 
• Archiving