From site qualification to closeout, we can help you resourcing monitoring needs across the East Canada and East Coast US. Reach out now!
Our areas of interest where we have most of our experience:
- Gene Therapy, AAV
- Cardiovascular devices
- Oncology monitoring phamarcy
- Rare diseases
- Orthopedics
- Biopharmaceuticals
CRA monitor patient eligibility, protocol implementation, data collection, adverse event reporting and regulatory document maintenance to ensure each study’s integrity.
Site Qualification
Successful investigator selection and recruitment requires site evaluation, clinical staff interviews and special study requirements. Oligenix plans, prepares, conducts and reports on each site qualification visit (pre-study screening visit) to ensure successful investigator selection.
Site Initiation Visits
At site initiation visits, Oligenix CRA review the protocol and investigational brochure with the investigator and clinical site staff and provide detailed instructions for CRF/eCRF completion. In addition, the CRA reviews regulatory documents, discusses patient enrollment goals, and reviews safety reporting, query handling and drug or device management.
Interim Monitoring Visits
Throughout the course of the clinical investigation, our CRA monitor the site and perform the following: review informed consent form completion, verify patient eligibility, monitor protocol violations/deviations, perform source and CRF/eCRF data review, retrieve clinical data (i.e., CRFs), monitor adverse event reporting, handle query resolutions, examine reasons for screen failure or withdrawal, review regulatory documents and perform drug or device accountability.
Close-Out Visits
Oligenix finalizes documentation at the clinical site in preparation for any pending audit by a regulatory agency. At the close-out visits, our CRA perform final source documentation and CRF/ eCRF data review; reconcile regulatory documents; finalize adverse event documentation, patient disposition and query resolution; and retrieve the remaining completed CRFs and resolved queries. Our CRA also perform final study drug and/or device accountability and return or destruction. Finally, the CRA review with the site personnel their obligations following study termination.