Clinical Study

iStock 000018458918XSmallClinical information is needed to demonstrate the benefits of using a device against the risks associated with its use. A manufacturer might demonstrate a device's safety by conducting a clinical literature review for similar products. If clinical data are limited, then a manufacturer must generate clinical information by conducting trials. When clinical research is required to support medical device R&D efforts, regulatory approval, or marketing strategies, expert guidance is essential.

Dr. Chen-Zion is uniquely able to help you design and execute feasibility, pivotal and post-market clinical trials, as well as animal studies. She takes a strategic approach to clinical planning, and she integrates regulatory and marketing concerns into the clinical plan up front. Her goal is to provide professional, customized solutions that help you achieve your immediate and long-term business objectives.

Clinical services include:

Study Design:

  • Strategy development
  • Design of study
  • Preparation of Clinical Investigation Package
  • Study Protocol
  • Case Report Forms
  • Investigator's Brochure
  • Informed Consent
  • Labeling
  • Administrative material

Study Regulatory Activities:

  • Submissions to Ethical Committees and Regulatory Authorities
  • Investigator Site File (ISF)
  • Clinical Standard Operating Procedures [SOPs]
  • Preparation of all study log-books forms required for study management

Management of the Clinical Study:

  • Site evaluation and selection
  • Pre-site activities
  • Site initiation and closure
  • Periodic monitoring and reporting
  • Intermediate and final study reports
  • Study management and coordination
  • Scientific writing for publication