In-vitro Diagnostic Device Trials
Specialized support to power your diagnostic breakthroughs
TriCore Research Institute (TRI) supports sponsors focused on the development and submission of in-vitro diagnostics across a variety of laboratory disciplines. We play a pivotal role in benchmarking studies, proof-of-concept projects, and FDA-regulated device clinical trials, including 510(k), premarket approval (PMA), and de novo studies.
Services
- Investigational and reference testing
- Subject recruitment, consenting, and phlebotomy
- Site study coordination and IRB submission
- Contracting, site set up, and budgeting
- Data management via electronic data capture and case report forms
- Specimen receiving, handling, and long-term storage
Capabilities
Our expertise spans diagnostic specialties across most disciplines of laboratory medicine.
Our capabilities include:
- Data capture, IRB submission, regulatory binder maintenance, and auditing that support 510(k) and PMA submissions to the FDA, as well as pre-clinical, pilot, and benchmarking studies.
- Providing remnant, de-identified samples, or prospective consented specimens to help generate data for product development and trial purposes.
- Maintaining and monitoring physical spaces to support investigational and research-only instruments and assays, which facilitate development or trial-related activities in high or moderate-complexity settings, or those with CLIA waivers.
- Offering an extensive variety of platforms and assays that may serve as comparator or predicate methods.
Talk with a Research Coordinator for a complete list of platforms and assays available.
Additional Support
TRI’s Central Lab Services offers access to TriCore’s clinical reference laboratory, which is CLIA certified, CAP LAP and 15189 accredited, with a comprehensive menu of over 2,900 tests.
TRI’s Biorepository offers specimen procurement and shipping and has an IRB-approved protocol for offering de-identified remnants.
A Dedicated Support Team
The TRI team consists of dedicated research staff certified in Good Clinical Practice (GCP) and Human Subjects Research (HSR). In addition to three dedicated, full-time medical directors, the team includes:
- Principal Investigators, PhDs and MDs
- Laboratory Scientists
- Phlebotomists
- Laboratory Assistants
- Research Coordinators
- Archivists
- Quality and Logistics Coordinators
TriCore medical directors are subject matter experts in a variety of clinical disciplines, including chemistry, hematology, serology, immunology, infectious disease, microbiology, urinalysis, sequencing, cytology, histology. In addition, TRI’s variety of staff offers qualified personnel in waived, and moderately and highly complex testing.
How We Work With You
Interested in learning more?
Before a study begins, TRI prepares by:
- Requesting a feasibility form from the sponsor to evaluate the research need and clarify details, ensuring necessary expertise, instrumentation, resources and timelines align.
- Working diligently to protect sponsor IP and enact NDAs and confidentiality prior to sensitive IP discussions.
- Discussing protocol to define testing assays, workflows, and study logistics.
- Creating a master contract to outline roles, terms, payments, and other key agreements.
- Preparing a submission for Institutional Review Board (IRB) approval.
- Scheduling all necessary pre-study meetings and trainings.
Once we are selected as a site, our support includes:
- Completing IT Security Risk Assessments (SRA) for the placement of instruments, if needed.
- Assigning a dedicated study team to perform all contracted portions of a study.
- Supporting instrument training at the site location or at the sponsor’s assigned facility as applicable.
- Conducting proficiency or familiarization runs, if necessary, to ensure workflow meets study design and criteria.
- Managing site initiation visits, interim monitoring visits, subject recruitment, sponsor communications, and ongoing site coordination.
- Offering scientific consulting and ensuring compliance with regulatory requirements.
- Maintaining accurate data, regulatory binders, meeting study deadlines, and resolving discrepancies identified during monitoring.
After the study is completed and data has been submitted, we finish the job by:
- Scheduling a close-out visit to review the regulatory binders and all study-related documents.
- Archiving study binders.
INSIGHTS
How TriCore Benefits TRI Sponsors
TriCore Research Institute (TRI) is owned by TriCore, an independent, not-for-profit clinical laboratory based in Albuquerque, New Mexico. Since joining TRI in June 2024, I’ve had the opportunity to explore how our connection to TriCore enhances TRI’s capabilities and brings unique advantages to our sponsors. Platform Accessibility TRI has access to TriCore’s array of instrumentation…
TriCore Research Institute (TRI) Attends the Confederation Latin American Biochemistry Clinical (COLABIOCLI) Conference
This past October, attendees from Latin America and around the world gathered in Cartagena, Colombia to attend the Confederacion Latinoamericana de Bioquimica Clinica Conferencia (COLABIOCLI). Closely aligned with the Association for Diagnostics & Laboratory Medicine (ADLM), the COLABIOCLI’s main focuses are on sharing lab expertise and educating laboratorians in Latin America This year’s conference…
Point of Care Testing: A Blessing or a Burden?
Point-of-care testing (POCT) refers to medical diagnostic testing that is performed near the patient, often at the bedside, rather than in a centralized laboratory. This type of testing provides rapid results, allowing healthcare providers to make immediate treatment decisions. POCT devices are typically portable, easy to use, and require minimal training. They are suitable for…
Connect with us to explore how TriCore Research Institute can help you venture into a new frontier with absolute confidence.
"*" indicates required fields