Clinical Operations Monitoring Services for Medical Devices

MakroCare offers clinical trial monitoring and site operations management services in different models (onsite, remote, centralized, hybrid) to fit study goals and budgets. All monitoring activities are conducted in accordance with the study guidelines, clinical monitoring plan, standard operating procedures, GCP, and applicable regional regulations.

Our Role

Our Clinical Trial Monitors perform following of Site Management and Monitoring Functions:

• Site Evaluation and Selection
• Site feasibility assessments
• Budget and site contract management
• Ongoing site monitoring & management
• Remote monitoring via EDC
• 100% Targeted or Risk Based monitoring
• Regulatory and essential document Management
• Electronic Trial Master File management (eTMF)
• Management/facilitation of IRB/EC submissions
• Site Close Out
• Archival

Why MakroCare?

• Our Clinical Operations team is experienced in managing clinical trials of varied size and complexity in different Device areas
• Our approach of providing a clinical study monitoring team that comprises both MakroCare employees and trusted global consultants, many of whom we worked with for years, provides most effective and flexible solutions for each project by enabling clients with a skilled and therapeutically focused team
• Our team developed a well formulated standard operating procedures and regional operational requirements to facilitate all types of clinical trials