Clinical Operations

We provide efficient pre-study, initiation, interim, and close-out services to support all clinical study needs.

inSeption’s Clinical Operations subject matter experts are integrated into the project team.  Our teams comprise fully dedicated, experienced clinical professionals who have a documented track record of providing quality work and are driven by service thereby eliminating costly rework.

Overview of expertise:

  • Identifying the best sites to meet enrollment targets and study timelines.
  • Training of site staff to ensure compliance with ICH/GCP regulations, the study protocol, and other study related documents.
  • Reviewing study files and source materials against the Trial Master File (TMF) to ensure compliance to SOPs and regulatory guidances.
  • Understanding of tools and technology critical for efficient clinical trial implementation and operation.