Therapeutic Areas: In-Vitro Diagnostics (IVD)

In-Vitro Ingenuity,
In Vivo Progress

Groundbreaking in-vitro diagnostics (IVD) advancements are outpacing drug and medical device developments.

To bring these cutting-edge IVD technologies safely and rapidly to market, it's important to have a partner that is familiar with the various IVD segments to ensure success and speed-to-market.

The future of healthcare is unfolding at lightning speed.

Whether your IVD solution is still in early research or nearing commercial launch, our experts have extensive experience in navigating the complex regulatory and reimbursement landscape.

Areas of IVD Product Experience Clinical Phases

Areas of IVD

Proxima can deliver guidance and support to emerging and established 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

Blood Gas Analyzers

Pregnancy Self-Testing Strips

Assays

Expedited clearance

Drug Test Kits

Statistical analysis reports

Various Assay Panels and Biomarkers for Cardiology and Oncology

Expertise in every phase of development

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.

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.

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:

Protocol Development and Trial Design

Site Selection

Vendor management

Biostatistics

Site Payment and Contract Support

Reimbursement and Payor Support

Project Management

Clinical Lab and Data Collection

Quality Assurance

Data Management

Site and Lab Feasibility and Start-up

"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."

Position

First & Last Name

Position

First & Last Name

We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!

Regulatory & QA Manager

Michael Selva

Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.