Investigator-Initiated/Study Management
The process of submitting a new drug, device or procedure for FDA review is a huge undertaking, requiring extensive background research, significant funding and often times numerous clinical studies to prove efficacy. With a mission that includes helping clients to advance and accelerate therapeutic clinical drug and device development initiatives, our Clinical Operations Group focuses on providing investigator–initiated studies with the support needed to reach their goals.
Experience:
With over 30 years of combined experience within the clinical data management industry, ClinOps has the tools to facilitate investigator–initiated studies and provide the most effective, cost–efficient means of completing a successful trial. We provide a single, consistent point of contact to advise and ensure that not only is the necessary data being closely monitored and cleaned, but that all regulatory documentation is in place and that the post–study analysis is submission-ready.
Technology:
The Clinical Operations Group embraces technology, using an advanced, web-based query resolution system to provide you with significant time and cost savings on site monitoring. With our web-based project management system, our project managers have immediate access to all logistical aspects of a trial, enabling real–time status reporting to you.
Project Management:
Effective project and site management is essential to the successful completion of your study. With a staff of project managers, study coordinators and medical research associates (MRAs or Monitors), the Clinical Operations Group assures that your studies are managed by experienced clinical research professionals based in our ClinOps East facility, as well as in strategic locations throughout the United States.
Clinical Operations Service for Investigator–Initiated Studies Include:
- Medical writing
- Investigator and vendor contract management
- Site qualification
- Regulatory support
- IRB approval facilitation
- CRF development, design and production
- Investigator meeting management
- Drug packaging liaison
- Financial management
- Clinical monitoring
- Project management
- Site management