clinical research operations

inSeption’s Clinical Operations subject matter experts are integrated into the project team:

  • Fully dedicated, experienced clinical professionals who have a documented track record of providing quality work and are driven by service; thereby, eliminating costly re-work.
  • Expertise in efficient pre-study, initiation, interim, and close-out services.
    • 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, source documents, etc against the Trial Master File to ensure compliance to Standard Operating Procedures and regulatory guidance.
    • Understanding of tools and technology critical to efficient clinical trial implementation and operation.