Your Project. Our Priority.

WORLD-CLASS CLINICAL / REGULATORY SERVICE FOR MEDICAL DEVICE, PHARMA AND DIAGNOSTIC CLINICAL TRIALS.

How can we help?

PARTNERS INCLUDE:

Experience the HCC difference

The HCC team consists of carefully selected and committed professionals with decades of experience managing medical device, pharma, and diagnostics clinical trials.

Our Services

  • Regulatory Affairs/FDA submission support

  • Comprehensive Project Management

  • Site Management

    Including Site Payments

  • Study Management

    Including Inventory Management

  • Study Monitoring

  • Device Training/Clinical Specialist Support

  • Clinical Safety Management

  • Clinical Data Management

  • Biostatistical Support

  • Site and sponsor BiMO inspection preparedness

  • Technical/Medical Writing

  • eTMF Management

  • Enrollment Enhancement

Partnering with HCC Ensures:

  • Leaders in the field executing your project
  • Expert execution of medical device clinical trials (FIM, EFS, PMA, Post-market Surveillance)
  • Dedicated personnel throughout the life of your study
  • Access to a host of EDC platforms (as a preferred provider)
  • Metric driven project management – on time and on budget

About Us

Hart Clinical Consultants (HCC) was founded in 2011 as a staff augmentation service to medical device companies executing clinical studies. Since, HCC has matured and evolved to being a full-service CRO offering unparalleled guidance and support for all phases of clinical study. HCC’s mission is to not only be a relied upon clinical partner, but also a sound steward and business partner, carefully managing available resources.

HCC offers a full complement of clinical and regulatory services, capable of expertly managing both US-focused and global clinical study.

MOVING INNOVATION FORWARD

Our Mission

  • PARTNERSHIP

    We strive to exceed our clients’ expectations, working as partners through the entire research process. From our customer interactive proposal design to final clinical study report – HCC is there.

  • TEAMWORK

    By “wearing the coat” of our clients, our experts integrate into your research process as a natural extension of your team. Our unique ability to blend ensures ongoing like mindedness and focus on common goals and successful outcomes.

  • FOCUS

    We understand the significance and importance of your trial. This galvanizes our commitment to move your project forward successfully and with care – on budget and on time.

Let’s Talk

To learn more about our services and discuss how we might partner with your organization, fill out the form below and we’ll be in touch.

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