Clinical Operations

CRMG was built on the foundation of our leadership’s formative experiences in biotech. Our strength is in truly understanding the needs and various drug development challenges of small to mid-size companies. The clinical operations team that CRMG assigns to your project will become a trusted and thoughtful asset to your company, and not just another vendor. This philosophy is the paradigm on which the CRMG organization has been built. For each project, the team is handpicked based upon experience, availability and your corporate requirements. All clinical programs are created equally at CRMG, meaning regardless of the size, scope or complexity of the individual project, we will provide exceptional service according to your expectations.

Flexibility in our approach to our customers' needs is a key success factor, which is why CRMG works closely with our clients to provide a range of support from à la carte services to full-service program support. Our clinical operations services include:

Program and study feasibility
Program and project management
Site identification and selection
Traditional and risk-based monitoring
Site management
Organization and maintenance of the trial master file (TMF)
Third-party vendor selection and management for:

Data management and EDC
Statistics
IXRS/IWRS
Central laboratory services
Individual IRB and central IRB services
Meeting planning
Expert panels, including data safety monitoring boards and adjudication committees

All of our services are delivered with our customers’ objectives in mind, and as a customer focused organization, we endeavor to be responsive, flexible and mindful of the changing nature of our business. We begin each new project with a successful outcome in mind, engaging rapidly, strategically and in an organized manner so that we are well-positioned to deal with challenges and issues that may arise during the course of a study.