Monitoring is the act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements.
A Clinical Research Associate (CRA) is a profession defined by Good Clinical Practice guidelines (ICH GCP). While ICH GCP uses the term "Monitor" instead of CRA, the two terms are synonymous. The main function of a Clinical Research Associate is to monitor clinical trials.
Services we offer
Site management and monitoring of clinical studies according to SOPs, ICH Guidelines and GCP and/or ISO
Implementation of project plans as assigned
Clinical Site Visits
Site Selection Visit (SSV)
Site Initiation Visit (SIV)
Site Monitoring Visit (SMV)
Site Close-Out Visit (SCV)
Site visit reporting and follow up letter writing
Source data verification, data resolution
Drug accountability
Oversight of agreement negotiation / implementation
Oversight of Ethics Committee submissions
Patient enrollment management
Acting in the project role of as Local Project Coordinator or Lead CRA as assigned
Mentoring and training junior staff including co-monitoring visits and visit report review
Group process improvement activities including revision of SOPs
