Field Support
Dedicated support for your investigational site – depending on the needs of the clinical investigation. Each role provides distinct, targeted support throughout the study.
Technical Support
Our team of Clinical Field Specialists (CFS), also known as Field Clinical Specialist (FCS) or Field Clinical Engineer (FCE) are technically trained specialists who support site staff in the correct and safe use of the investigational medical device. Present at procedures, they act as a direct resource for the site team, ensuring medical device handling meets protocol requirements and that any technical questions are answered on the spot.
The activities below provide a few examples of how a CFS can support sites across the different phases of the study procedure.
Pre-procedure — Evaluates patient eligibility, confirms medical device readiness, and prepares the site team through training and procedural alignment.
During the procedure — Provides real-time technical guidance during implantation and/or explantation, troubleshoots medical device-related issues and monitors medical device performance throughout the procedure.
Post-procedure — Verifies accurate data capture, supports adverse event reporting and assists with follow-up visits and planning.
Clinical Support
A study nurse supports site staff across all aspects of a medical device clinical investigation: from administrative coordination to hands-on clinical activities as defined in the protocol and within their scope of practice.
The overview below provides a few examples of the tasks a study nurse can take on across the different phases of the investigation. The actual scope will always be defined by the protocol and the needs of the site.
Pre-procedure — Screens patients for eligibility, manages informed consent process and prepares study documentation and scheduling.
During the procedure — Performs protocol-defined clinical tasks in support of the study medical device procedure, assists with patient assessments and data capture and monitors patient wellbeing during, the study procedure.
Post-procedure — Ensures accurate completion of case report forms, supports adverse event reporting and coordinates patient follow-up.
Tailored to your study needs
Every project has its own requirements. As medical devices grow more complex, some sites benefit from a Clinical Field Specialist to support the technical aspects of a procedure, while others benefit from a temporary Study Nurse to manage the administrative workload of a clinical study.
At XPER, we tailor our field support to the specific needs of each client and each project.
Contact
Hans Tielemans
hans.tielemans@xperresearch.com
+32 475 95 93 69
