Site Management Organization (SMO)

Triumpharma provides the following services:

  • Identification of the relevant clinical sites, SIV, PI selection, patient recruitment and finalization of needed contract agreements with these stakeholders.
  • Submission for (IRB/IEC) and approval.
  • Submission to JFDA and approval.
  • Site Feasibility and selection and full project managements services.
  • Appointing cCRAs.
  • Patient Counseling and Recruitment.
  • Patient Follow-up.
  • Informed consent form (ICF) translation into vernacular languages.
  • Site initiation, Activation and trial close-out operations.
  • Trial-related documents archival and maintenance.
  • Reporting serious adverse eventsto 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