If you're the head of your clinical study, your sites are the hands and feet. Effectively managing these touch points between your team and your subjects is critical to your success. We offer experience in managing partner sites around the globe.
Our site monitoring services include:
Conducting telephone interviews to determine interest, availability & expertise
Investigator confidentiality agreement
Conducting site qualification visits
Evaluating sites for clinical trial participation
Preparing Site Qualification Visit Reports
Supporting investigator meetings
Monitoring interim visits, including source data verification, and IRB/SAE document review.
Close-out visits, including final study binder review, final drug accountability and return, and review of study documentation
Investigator contract/budget negotiation and management
Using tools and metrics during Start Up to ensure only the best investigative sites are selected
Continual communication and training with investigators and site staff
Trial Master File setup and management.
And of course, ongoing trial site monitoring.