Site Monitoring
Managing Sites Locally and Around the Globe
On-Site and Remote Monitoring
If you're the head of your clinical study, your sites are your extremities. Effectively managing these elements between your team and your subjects is critical to your success. To aid your efforts, we offer experience in managing sites around the globe.
Our site monitoring services include:
Conducting site selection by contacting potential sites to determine interest, availability & expertise
Assisting with initiating and finalizing Investigator confidentiality agreements
Conducting site qualification visits
Preparing Site Qualification Visit Reports for Sponsor review and selection of sites
Assisting Clinical Trial Manager with the preparation and set-up of Trial Master File
Supporting the preparation and execution of investigator meetings
Assisting sites with the preparation and submission to central or local IRBs
Conducting Site Initiation Visits either in-person or remotely to ensure compliance with final protocol
Preparing Site Initiation Visit Reports for Sponsor review
Conducting interim Monitoring Visits as per the Monitoring Plan
Preparing Interim Monitoring Visit Reports for Sponsor review
Interacting with sites on an ongoing basis to respond to site issues and minimize the number of protocol deviations
Reviewing entered study data and generating manual queries
Ensuring all system or manually generated queries have been resolved prior to data base lock
Conducting Close-out visits to confirm that all study documentation has been finalized and investigational product disposed of or returned to Sponsor
Preparing Close-out Visit Reports for Sponsor review
