Geneva manages human subject clinical trials by serving as an intermediary between the CRO/sponsor and the military site, assisting with contract execution, and meeting project and reporting timelines. Geneva employs certified Clinical Research Coordinators (CCRCs) onsite to successfully execute the expectations of the sponsor and researcher. Our team consists of experienced, responsive project leaders who provide on-time, quality data in accordance with the sponsor’s expectations and applicable governing regulations.VIEW SOME OF GENEVA’S INDUSTRY SPONSORS
Geneva’s services in support of industry-sponsored research include:
• Proposal and protocol development
• Negotiation and execution of the Clinical Trial Agreement and/or CRADA
• Coordination of budget development
• Financial management
• Regulatory management, submission, and compliance by dedicated regulatory staff
• Experienced Clinical Research Coordinator support
• Ongoing project management oversight
• Coordination of subject enrollment & clinical conduct in support of protocol
• Compliance with FDA regulations and GCPs
• Management of study close-out and financial reconciliation
ACCESS TO RESOURCES
Geneva provides access to specialized equipment, laboratories, and experts who are scientific leaders in their field of interest. Working with Geneva brings industry access to subject matter experts with innovative approaches, perspectives, and diverse ideas to enhance research goals and execution.
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTS
Geneva has extensive experience developing, negotiating, and executing CRADAs. The purpose of a CRADA is to make government facilities, intellectual property, and scientific expertise available for collaborative interactions in the joint pursuit of common research goals between government entities and research partners from the non-federal sector. Geneva executes Master CRADAs and single-use CRADAs with our collaborators.
BENEFITS OF WORKING WITH MILITARY POPULATIONS
The military community offers a diverse research population of active duty personnel, their families, and veterans. Military populations are representative of the diseases, trauma, and conditions that occur in both military and civilian communities. Additional benefits of conducting human subject research within the military populations include: highly compliant patient populations; electronic health records; onsite primary care, specialty care, and auxiliary services; and a single clinical trial agreement that supports the involvement of several sites.
Clinical Trials Research Indications