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Exciting in-vitro diagnostics (IVD) advancements are occurring earlier than in drug and medical devices. To progress these technologies through the regulatory and reimbursement landscape, it’s important to stay on the cutting edge of science.
Whatever your stage of development, it’s critical to find a like-minded and qualified research organization that is familiar with various IVD segments ensuring success and speed to market.
Proxima can deliver guidance and support to emerging andestablished IVD companies working in the following areas:
LDTs (Lab Developed Tests)
POCS (POINT OF CARE TESTS)
COMPANION DIAGNOSTICS
CLINICAL / MOLECULAR DIAGNOSTICS
INSTRUMENTATION/ LAB-BASED DATA MANAGEMENT SYSTEMS
MOLECULAR DIAGNOSTICS
PRODUCT EXPERIENCE
Proxima’s ability to guide our developing partners through the regulatory, trial design and clinical evaluation stages make us a trusted outsourcing partner.
Our track record of success with companies includes but is not limited to the following types of devices:
Blood Glucose Monitors
Pregnancy Self-Testing Strips
Drug Test Kits
Blood Gas Analyzers
Hemoglobin Assays
Various Assay Panels and Biomarkers for Cardiology and Oncology
Diagnostics, like medical devices, are classified as either Class I, class II, or class III, according to the level of regulatory control required to assure safety and effectiveness.
At Proxima we understand the classification process and the strategy needed to define the product, deliver on the clinical strategy and the design and support for pre-market approval.
Whether your product is being evaluated in Europe, Asia, North America or Latin America, we can support a variety of trials ranging from 510(k), LDTs, CLIA and PMAs.
Proxima's expertise in IVD clinical development includes the following.
