Medical Devices & Diagnostics

Effective start-up of clinical development projects and programs for medical devices and diagnostics requires an in-depth understanding of the nuances of regulation and investigator site landscape that apply. With more than 28 years of experience in delivering clinical development programs globally in a broad range of therapy areas, ClinChoice delivers efficient start-ups and ensures that patient enrollment commences on schedule.

Regulatory Expertise

Our global team consists of local staff with a deep understanding of regional regulatory requirements. We’re constantly monitoring the global regulatory landscape, tracking changes in legislation, guidelines, and regulations that apply to medical devices of all classes and developmental stages. We utilize our expertise to develop an effective regulatory strategy, define the required documentation, and coordinate translations to ensure a complete application package for authorities and ethics committees.

Comprehensive Start-Up Services

Trial sites required to support medical device and diagnostic clinical development may be less experienced in conducting research than those involved in drug trials. ClinChoice prioritizes the right support to sites to ensure effective start-up delivery. Our study start-up experts excel in personalized project management and site start-up organization. From project onset, we support sponsors with professional interpretation of regulations and site processes, helping to lead studies and save time in recruitment.

  • Comprehensive site setup
  • Competent Authority / Health Authority submissions and approvals
  • Ethics Committee (EC) submissions and approvals
  • Investigator site contract negotiations and signoffs
  • Essential documents collection

Scope of Start-Up Services

We specialize in developing and implementing site initiation strategies for medical device and diagnostic investigations that are aligned with protocols, contractual scopes, SOPs, and GCP requirements. Our commitment extends to risk management and strategic support for swift, high-quality start-up solutions.

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