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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:

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

Why MakroCare?

  • BulletOur Clinical Operations team is experienced in managing clinical trials of varied size and complexity in different Device areas
  • Bullet 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
  • Bullet Our team developed a well formulated standard operating procedures and regional operational requirements to facilitate all types of clinical trials

Clinical Monitoring vendor whether 1 study or multiple visits, Leverage
our global CRAs/Monitors for bote Remote and Centralized monitoring

The First Step

Let's talk about how MakroCare can help you