Monitoring is very important aspect of trial. The monitor is the main communication link between the Sponsor and the Investigator. In very simple understandable language Monitoring is the Act of overseeing progress of a clinical trial and ensuring that it is conducted, recorded and reported in accordance with protocol, SOPs, GCPs and applicable regulatory requirements.
Auriga has well experienced team of Monitors/CRAs and we have the flexibility of working with the monitors appointed by Sponsor CRAs/Monitors. Monitors at Auriga are well trained and experienced with the stages of a Monitoring Visit & advance planning.
For outsourced monitoring services Auriga can be broadly categorized in four types of Site Visits
- Site Assessment (Pre-study) Visit is to evaluate site’s / investigator’s resources and capabilities to conduct a research study in term of Site infrastructure, Adequacy and availability of site facilities for study conduct.
- Site Initiation Visit is planned to uniformly provide study-specific information to investigator(s) and staff prior to study start-up and reassess resources and capability to conduct a research study. The monitor will also discuss with the clinical staff about research obligations as per GCP. The monitor will also provide necessary guidance to the site as determined by his/her findings.
- Interim Monitoring Visit is planned to assess the progress of trial in terms ofAccuracy, completeness and verification of reported trial data. Majorly monitor will review Study Product Accountability, review of Protocol-Specific Record, CRF review, assessment of Laboratory.
- Close out Site Visit is planned after study completion/withdrawal. The monitor will submit the final report submitted to IRB/IEC and sponsor. The monitor will obtain copies of all study product shipping, receiving, and accountability records for submission to sponsor.