Medical and Diagnostic Device Development

Looking for an integrated medical device and in vitro diagnostic (IVD) CRO partner? When it comes to ensuring compliance and insight, keeping your trials and studies on track and bringing your medical device to market faster, developing a strategic partnership makes all the difference. From bench and preclinical testing to clinical trials and post-market device studies, we can help you to reach and maintain regulatory approval.

80+

70+

15k

165+

PMA or 510(k) submissions

countries with patient access

individual protocols

companion diagnostics

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Regulatory

    • IDE, PMA, HDE, BLA, 510(k), de Novo 510(k), CLIA Waiver
    • MDR, IVDR, CDR, CE Mark & Design Dossier/Technical File
    • Global strategic regulatory consulting, registries & submissions
    • Regulatory report writing

Preclinical & Surgical

    • Non-GLP & GLP (acute and chronic)
    • Experimental surgery & model development
  • Imaging equipment and capabilities

  • Cadaver studies with physician/sales training

Clinical Trials

    • Protocol development
    • Feasibility/Pilot & Pivotal
    • Global clinical trials development plan
    • Diagnostic analysis
  • Site & patient recruitment/qualification

  • Centralized lab testing

  • Manufacturing support

Commercialization

    • PMS & PMCF
    • Real-world evidence studies
    • Pharmacovigilance
    • Health economics
  • Reimbursements

Harmonized Rx & Dx Development for In Vitro Diagnostics (IVDs)

Work on your therapeutic compound solution at the same time as your IVD

Our integrated approach to both drug and device development, spanning all phases of the development lifecycle, can reduce your overhead and let you build both your therapeutic compound and in vitro companion diagnostic (IVD) at the same time. 

    • Biomarker identification & development
    • Assay feasibility, proof of concept and validation
    • Global clinical trial testing
  • Premarket approval application (PMA)

We have supported ~15 of the 19 FDA-approved companion diagnostics

Therapeutic Expertise Where You Need It

We have conducted nearly 300 studies in the following key therapeutic areas with 1 out of 4 of our device trials being cardiovascular focused.  

  • Cardiovascular

    Dermatology

    Endocrinology

    Neuroscience

    Oncology & Immuno-oncology

    Orthopedics

    Opthalmology

  • Radiology (nuclear science)

    Women's health

    Vascular

    Gastrointestinal

    Wound healing and traumatic injury

    Tissue engineering

    Urogenital

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Equipment & Facilities to Facilitate Your Research

Equipment

  • New: Philips Cath Lab – Allura Xper FD20

    Fluoroscopy / OEC 9800 and OEC 9900

    GE Visual IQ With 4D TEE & ICE

    OCT Intravascular Imaging System

    Endoscopic Towers (Olympus)

    Laparoscopic Towers (Stryker)

    Boston Scientific Galaxy

    IVUS

    Cardiopulmonary Bypass

    Audio / Video Conferencing Center

Surgical Facilities

PreclinicalSurgicalLab

Conveniently located in the San Francisco Bay area, our AAALAC-accredited research facility is designed with experimental surgery and you in mind. This is a research space to accommodate both large and small groups, while giving you the feel of being in your own office.

   

One Expanded Device Solution, Designed Around You

By combining the core strengths of Covance and LabCorp with two key acquisitions of Chiltern and Preclinical Medevice Innovations (PMI), Covance has assembled an experienced device team ready to help you craft a device development path, uniquely Designed Around You. With these expanded solutions . . . 

    • You can use the same partner for your preclinical studies as your clinical trials. 
    • You can work on your therapeutic drug at the same time as your in vitro companion diagnostic device. 
    • You won't need a third partner to submit your regulations.

Receive a tailored device development experience, distinctly designed for you--tailored to your company, therapeutic indication and development strategy.

Glucosetest

Case Study

Recruiting a global population for a complex infectious drug-device disease clinical trial.

Read the case study >

Whitepaper

Molecular imaging is important in the diagnosis, detection and treatment of cardiovascular, oncologic and other diseases.

Read the whitepaper >