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