Leading expertise in complex studies for products worldwide.

Few, if any, research partners our size have the depth of experience in medical devices and diagnostics that Chiltern does — and there may be no better indicator of success for your next trial than experience built on repeat client satisfaction. We have an exceptional depth of knowledge in cardiovascular, endocrinology, oncology, orthopedic and women’s health applications of medical devices, and, over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical products. No matter what your market registration objectives, we apply that unparalleled track record in device and diagnostics development to create a program Designed Around You®.

The device team at Chiltern was one of the first to manage programs for the development of combination device/drug delivery systems, and our regulatory team is on the forefront of the development of guidelines governing mobile medical technology. In fact, in the course of our team’s work in this field, we have developed expertise in 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

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 foremost experts 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 ongoing marketing expansion support.

Device & Diagnostics Development Therapeutic Expertise

Device & Diagnostics Development Services

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