RESEARCH PHASES II – IV
The experience to effectively handle any situation
MediMonitoriu’s experienced research professionals are capable of managing even the most complex Phase II-IV clinical research studies. Our therapeutically focused teams of clinical experts have the knowledge and experience necessary to effectively manage any situation that may arise in your trial. Our approach is firmly grounded in comprehensive project management principles and well-defined processes.
Phase II-IV services
- Project management
- Protocol development
- Site identification and selection
- Site qualification
- Investigator contract negotiation
- Regulatory document management
- IRB/EC submission
- Investigator meeting preparation
- Site initiation
- Clinical monitoring
- Site management
- Patient recruitment support
- Investigator grant management
- Trial master file management
- Vendor management
Strong site relationships
We select the right investigative sites to achieve enrollment targets within required timelines, maintaining an investigator network that encompasses all major therapeutic areas. We use comprehensive study-specific questionnaires, feasibility assessments, and expert evaluations of potential sites to ensure a high probability of success for each study.
Experienced, highly trained monitors
Our project teams work closely with sponsors and investigative sites through regular communication and monitoring. We employ highly experienced, regionally based CRAs who are fully conversant in English and their local language, understand how to support each investigator to maximize quality and performance, and participate in a rigorous, comprehensive training program. Our CRAs are extensions of their teams and can be relied on for the full support necessary to effectively manage any study. Equally important is their familiarity with local ethics and regulatory requirements — knowledge that’s invaluable in reducing approval process timelines.