Monitoring of Medical Device Clinical Trials

Your clinical trial requires Good Clinical Practice (GCP) and ISO 14155 compliance, how do you ensure this quality level throughout all sites? As a full-service CRO, Qserve has experienced clinical research associates (CRAs) within their team and abroad worldwide network of monitors. 

What does Qserve monitoring look like?

When you delegate your monitoring activities to Qserve, we will create a tailored monitoring plan. Our CRAs will make site visits, write monitoring reports, and follow-up findings, fully SOP and regulatory compliant. .

Qserve allocates one of its dedicated monitors/CRAs to your study and site(s), to establish a good site relationship and serve as the site’s primary point of contact. The monitor’s in-depth knowledge of the protocol, ICF, CRFs, operational and procedural plans results in efficient and compliant monitoring. We support site selection and initiation, interim monitoring, close-out visits, (re-)training of sites, file reviews, query resolution and support of follow-up actions.

Our monitors are comfortable with remote monitoring and risk-based monitoring, as well as 100% on-site source data verification (SDV).

Qserve offers practical, tailored and compliant monitoring. 

Qserve advantages:

  • GCP and ISO 14155 compliant monitoring
  • All our monitors have medical device experience
  • All types of Sponsored studies, from First-in-Man to PMS Flexible, custom approach including risk-based monitoring
  • Support and training of research naïve sites
  • Regular and dedicated sites contact 
  • International reach and CRA network
  • Strong regulatory support
  • Modular service packages
  • Competitive pricing
  • Short communication lines

Want more information? Get in touch with us

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