Support Research Team in loco
To assure the execution of standart procedures:
- Drafting protocols in collaboration with Principal Investigators
- Regulatory support to get the local site approval
- Trial planning
- Preparation of study timelines
- Assistance with sites training
- Assuring the Research Team compliance with the study timeline and milestones
- Study management in the sites
- Providing logistical support with packaging and transport of samples and/or of experimental drug
- Master trial materials development & guidance notes for investigator & pharmacy files
- Help identify & address barriers to timely recruitment
- Facilitation of audits & regulatory inspections in all study sites
- IMP Management
- Organisation of investigator or training meetings
- Finantial study management
- Submission of amendments, progress reports and safety reports