Field Clinical Consulting Value Proposition

Sound clinical study execution is critical to maximizing return on investment for the study sponsor as well as clinical investigators.  By employing well-trained and experienced Field Clinical Engineers (FCEs), you ensure protocol adherence, proper and consistent product use, and complete data collection.  Experienced FCEs develop site relationships that accelerate enrollments, maintain momentum, and serve to reinforce proper patient selection.  The FCEs will also serve as the eyes and ears of the company, critically observing early product use and providing critical end user and environment observations to product development, training & education, and marketing.

Bartelt Field Clinical Consulting maximizes clinical study return while minimizing the risks of lost data, protocol deviations, and a negative customer experience. 

Field Clinical Consulting Services:

PLANNING

• Advise on Protocol, Site Selection, and Enrollment Strategy
• Assist with Site Qualification and Site Initiation Visits
• Advise on Protocol Design / Data Collection from a Field/Customer perspective
• Develop Field Coverage/Support Plan
• Advise on Clinical Product distribution, tracking and accountability
• Manage Site/Vendor Credentialing requirements

INITIATION

• Advise on and contribute to Site Training materials (Product, protocol, procedure)
• Train company engineers/personnel to support Clinical Trials including:

– Site Training, Implant Support, Follow-up Support
– Site Management (Improving Enrollment rates and data quality)

• Source FCEs
• Source Contract FCEs*
• Develop Enrollment Strategies to meet study timelines

EXECUTION and Ongoing SITE MANAGEMENT

• Oversee Site Management Plan
• Ensure sites stay focused on enrolling the ‘right’ subjects
• Keep study top of mind with investigators
• Support enrollments and follow-up to ensure proper protocol adherence
• Support accurate and timely data collection and submission
• Manage FCEs / Contract FCEs
• Provide ongoing Training of Contract and Company FCEs
• Mentor and Coach Clinical personnel

*Contract FCE Duties:

• Support and deliver site training (Product, Protocol, Procedure)
• Support clinical implants at sites
• Support clinical follow-ups at sites
• Provide technical support and troubleshooting at clinical sites
• Develop relationships that will accelerate enrollments and ensure appropriate patient selection
• Collaborate with company and site to ensure successful study execution
• Provide timely detailed feedback on product, procedure, protocol