Clinical Site Management

Green Light Clinical is an organization that provides clinical trial related services to a contract research organisation (CRO), a pharmaceutical company, a biotechnology company, a medical device company or a clinical site. Some (but not all) of our responsibilities include:

  • Clinical trial contract preparation and negotiation
  • Submission for Ethics Committee (EC) approval
  • Patient Counseling
  • Patient Recruitment
  • Patient Follow-up
  • Informed consent form (ICF) translation into vernacular languages, if required
  • Site initiation and trial close-out operations
  • Trial-related documents archival and maintenance
  • Reporting serious adverse events to the Sponsor or CRO and the IRB/IEC
  • Ensuring protocol compliance
  • Advising & alerting investigators of potential protocol violations
  • Advising & alerting investigators of potential ICH-GCP violations