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 * Clinical Monitoring Services
 * Clinical Study & Site Management
 * AI Q&A
   
   * Ask your clinical research questions
   * GLP-1 Agonists and Weight loss Questions
 * About
 * Contact

Navigation Menu
Navigation Menu
 * Clinical Monitoring Services
 * Clinical Study & Site Management
 * AI Q&A
   * Ask your clinical research questions
   * GLP-1 Agonists and Weight loss Questions
 * About
 * Contact




CLINICAL MONITORING SERVICES

From site qualification to closeout, we can help you resourcing monitoring needs
across the East Canada and East Coast US. Reach out now! Call us! 1 (800)
340-7802

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.

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