CROS NT provides Project Management and Monitoring of single/multiple site, national/multi-national clinical trials in strict accordance with national standards, ICH GCP guidelines, FDA regulations, Sponsor SOPs, as appropriate, and strict adherence to the trial protocol.
With wide therapeutic knowledge our project managers act as central points of contact to ensure the provision of support and advice to all members of the project team. Flexible, creative and good communicators, they ensure the most efficient and cost effective solution to invoke evidence-based trial feasibility assessment recommendations. This allows the team to enact rapid patient site recruitment, collection of high quality “clean” clinical data and maintain project deliverables on-time and on budget throughout the course of the trial by refining as necessary within the budgetary restraints and associated risks.
Project Management Services:
- Evidence-based feasibility assessment
- Study Protocol design/writing
- Trial Management Plan
- Risk management
- Contract & budget negotiation
- Ethical Committee & Regulatory submissions
- Project/Operations Management
- Investigator Meetings