Few, if any, research partners have the experience in medical device and diagnostics that Chiltern does.

We have an exceptional depth of knowledge in cardiovascular, ophthalmology, oncology, orthopedic, respiratory and women’s health applications of medical devices. Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical products. The device team at Chiltern was one of the first to manage programs for the development of combination device/drug delivery systems and is on the forefront of implementing the guidelines governing mobile medical technology.

Medical Device & Diagnostics Services

The Medical Device & Diagnostics team can help you with the following while you are developing your product:

  • Protocol development
  • Site/investigator selection
  • Clinical studies
    • Pilot/feasibility
    • Pivotal
    • Continued access
    • Post-market
    • Registries
  • Regulatory consulting
  • Adjunctive reimbursement programs
  • Safety surveillance/observational programs
  • Clinical evaluation reports

Mobile Medical Application Technology

Because of our continuing work with mobile medical applications, we now have insight into many of the key concepts related to mobile medical technology, including:

  • General and regulatory frameworks of mobile medical applications and regulation standards
  • Software programming, off-the-shelf software, cybersecurity and risk of mobile platforms
  • Preclinical and clinical operations: considerations for mobile technology resource requirements, usability and human factor requirements
  • Data integration, imaging requirements and visual analytics
  • Economic and reimbursement considerations for mobile technology in a clinical trial

No matter what your market registration objectives, we apply our unparalleled track record in medical device and diagnostics development to create a program that meets your needs. We take pride in working with you to bring new medical device and diagnostics solutions to market for patients around the world.

To stay on the leading edge of a whole spectrum of advanced technologies, Chiltern has also developed in-house expertise and formed strategic alliances with some of the most experienced leaders in electronic data capture, human factors and usability, imaging, and reimbursement and health economics of advanced diagnostics technologies including mobile medical applications.

Once a device is cleared for market entry, Chiltern will help develop post-market studies and adjunctive reimbursement plans to provide you with ongoing marketing expansion support.

Medical Device & Diagnostics Therapeutic Expertise

In the last five years, the Medical Device & Diagnostics team has conducted more than 350 studies.

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Medical Device & Diagnostics Solutions

You will feel as though Chiltern’s global, full-service research team is a part of your own team as you realize your project’s vision. We realize the clinical development process is lengthy, so we are committed to deploying exactly the right solutions at the most appropriate scale and at just the right time to maximize efficiency and minimize delays. Our global clinical development and scientific solutions are supported by best-in-class technologies and available in a variety of specialty areas.

Our capabilities perfectly match your situation and drive faster, smarter development.

Collaborative Approach

Our team will use our proven process to ensure your study management and data collection solutions are working together seamlessly so you can focus on your trial outcomes.

Connect Methodology

When you are looking for program performance that meets your needs and delivers actionable results, Chiltern’s Connect Methodology has start-to-finish flexibility Designed Around You.

Collaborative Technologies

When you need automation and analytical tools to visualize data and make decisions, Chiltern has modular study and data collection technologies Designed Around You.

Chiltern has been using Connect Methodology and Collaborative Technologies since 2005.

Risk-based Monitoring

When you need to execute your trials efficiently and with confidence, Chiltern develops the right strategy for your trials Designed Around You.

Oncology Product Platform

When you need a complete solution quickly, Chiltern enables you to set up a trial with one team, working from Phase I to Phase III, Designed Around You.

Site Engagement

When communication with your study sites is vital to your trial’s success, Chiltern has a site engagement team that provides study startup, feasibility and site training services Designed Around You.

Patient Recruitment and Retention

When enrolling patients is important to your study timeline, Chiltern has recruitment methods that find patients Designed Around You.

Strategic Development

When you need a partner to help fill your product portfolio, Chiltern has a team of consultants with insights Designed Around You.

Strategic Service Provision

When you are managing cost variability through workload peaks and troughs, Chiltern has talented individuals and teams with skills Designed Around You.

Global Reach

When you need localized expertise wherever you are, Chiltern has a global presence with study site locations Designed Around You.