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Sandara Maddock, CEO and President IMARC Research

Medical Device CRO

Our Company

IMARC Research is a global medical device CRO with two decades of proven experience ensuring patient protection and regulatory compliance for clinical research.

With locations in Cleveland, Ohio and Minneapolis, Minnesota, we have a stellar record with the FDA. In our more than 20-year history, none of the work resulting from our engagement with our sponsors and sites has resulted in a warning letter. 

IMARC brings an understanding of issues at both the site level and sponsor level. Our team can fully integrate with the study teams of sponsors while providing independence and objectivity.

Founded by former research coordinator Sandra Maddock, IMARC brings an understanding of issues at both the site level and the sponsor level. Our team can fully integrate into the study teams of sponsors or CROs while still providing independence and objectivity.

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our ORIGINS AND EVOLUTION

20 Years of Medical Device Expertise

IMARC CEO Sandra Maddock founded IMARC in 1999 after working in nursing and later as a research coordinator at a hospital. She realized there was a lack of standardized training and procedures when it came to protecting human subjects and complying with regulations. That’s when she made it her mission to provide comprehensive oversight for clinical research studies.

These principles have helped fuel IMARC’s steady growth during its history and remain core pillars for the company. 

Since then, IMARC has evolved from a largely one-woman operation to a successful mid-sized company that works with some of the largest medical device companies in the world. As the regulatory landscape evolves, IMARC is developing new global partnerships to meet the growing needs of medical device manufacturers. That includes expanding our presence in the European Union to meet new MDR and IVDR regulations.

 

Our Services

Ensuring Compliance

As a full-service medical device CRO, IMARC Research assists sponsors with conducting well-controlled, compliant, clinical research studies.  We are proud to contribute to the clinical research community by ensuring sponsors earn approval from the FDA or international regulators.  We do this by guiding and educating teams through the entire clinical trial lifecycle. Our team can also assist with specific tasks at any point in the process, providing independent monitoring, auditing, consulting, data management, safety services and more.

“For two decades, IMARC set the highest standards for site outcomes and study partnerships by providing committed, competent, and confident consultation.”

Benefits of working with IMARC include:

  • Backing of a company with a strong FDA track record
  • ISO certified, global, full service capabilities
  • Ability to select services based on specific needs
  • Independent, third-party oversight from a team of experts
  • Top management involvement and support
  • Strong budget management

IMARC can fully integrate into study teams of sponsors or CROs while still providing objective oversight and independent, expert recommendations.

Our team sets the highest standards for site outcomes and study partnerships. We are committed
to providing competent, confident oversight to ensure every study adheres to these standards
to achieve the ultimate goal of approval.

One

Upholding the highest ethical standards for clinical research

Two

Promoting excellence in research and data integrity

Three

Meeting clients’ needs in a timely, efficient and quality manner

Four

Contributing to advances in medical device development
and biotechnology

affiliations & certifications

IMARC Research keeps its pulse on advances in the clinical research community through our involvement in industry organizations. Our team members participate in local and national organizations and are invited to serve as speakers
or in key leadership positions.

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ACRP
SOCRA