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Clinical Operations (ClinOps)

What is clinical operations (ClinOps)?

Clinical operations, or ClinOps, refers to activities that support the complete clinical trial process, from start-up to completion.

An important role of the ClinOps team is to connect the various departments of the clinical trial, such as:

  • Data management
  • Clinical science
  • Regulatory
  • Statistics
  • Legal
  • Marketing
  • Safety

ClinOps interacts with all these groups on a regular basis, keeping them up to date on all relevant trial information. Since clinical trials are complex, it is essential for all departments to understand the same risks, strategies, and information.

In addition to the internal clinical trial group, the ClinOps team also interacts with external groups, such as:

  • Central lab vendor
  • ePRO vendor
  • Specialty lab vendors
  • Central imaging vendor
  • Contract research organizations (CROs)
  • IXRS vendor

Why is clinical operations (ClinOps) important for healthcare?

ClinOps professionals are responsible for planning, implementing, and managing the clinical trial process, with some of the tasks that they are responsible for including:

  • Identifying clinical trial sites and investigators
  • Developing protocol and other study documents
  • Fiscal management
  • Training, start-up, and management of clinical sites
  • Providing communication between all departments
  • Quality management