Profundus Health

HOME
ABOUT US
SERVICES
CLIENT SERVICE
CLINICAL RESEARCH
INFORMATION TECHNOLOGY
PRODUCT DEVELOPMENT
CLINICAL RESEARCH
CLINICAL DATA MANAGEMENT
CLINICAL OPERATIONS
MEDICAL WRITING
PHARMACOVIGILANCE
QUALITY CONTROL
STATISTICAL ANALYSIS SYSTEM
TECHNOLOGIES
DATA SCIENCE
INFORMATION TECHNOLOGY
SYSTEM APPLICATIONS AND PRODUCTS
TABLEAU
PARTICIPANTS
CAREER
CONTACT US

CLINICAL OPERATIONS (CO)

CLINICAL OPERATIONS (CO)

Profundus Health, 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 deliver array 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 Profundus Health?

  • 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 Profundus Health 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