Metrics Research also serves as a Site management Organization (SMO) for global sponsors and CROs. Perhaps the most crucial aspect of a successful clinical research study or trial is a fully compliant, functional site with all the necessary facilities and appropriately ICH GCP trained investigator and site staff.
Metrics Research believes very strongly in assisting and supporting sites on logistical matters, site staff trainings and keeping sites current on regulatory and protocol compliance. As an SMO we ensure that regulatory obligations and ICH GCP requirements of a clinical investigator site are fully enforced including availability of medical records and good source data ensuring preparation and maintenance of case histories, full compliance with IRB standard requirements. Other responsibilities included, but not exclusive are:
- Contract negotiations with the study institutions
- Institutional review board (IRB) approvals
- Patients recruitment and retention
- Patient follow-up
- Informed consent form (ICF) translation into vernacular languages
- Site initiation and close-out
- Clinical trial-related documents archival and maintenance
- Safety Reporting (serious adverse events to the Sponsors/CRO and IRB/IEC), among others
Metrics Research as an SMO brings with it the best processes to an investigative site enabling it to perform optimally. We ensure timely completion of quality assured sponsored clinical trials.