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Katrina joined Experien Group in 2007 with over 15 years of pre-clinical and clinical research experience at medical device companies. She has conducted numerous clinical trials in the United States and Europe for U.S. Class II and Class III devices and she possesses substantial clinical trial management expertise for cardiovascular and radiofrequency ablation devices. She has supported successful regulatory submissions for a wide range of products and she is highly experienced in directing companies’ pre-clinical activities (including cadaver and animal testing).
At Experien Group, Katrina directs and manages pre-clinical, clinical and regulatory projects with particular expertise in GLP animal studies and clinical trial management. She participates on multiple client companies’ design teams as the Regulatory, Clinical, and Pre-Clinical representative. In addition to U.S. pre-clinical and clinical regulations, she is experienced in compliance procedures for ISO 14155:2009 and the European Medical Device Directive. Katrina’s primary responsibilities include:
- Comprehensive pre-clinical and clinical operations from site selection through study close-out activities
- Clinical study documentation and interface for regulatory submissions and study approvals (e.g., IDEs, Institutional and Independent IRBs, and Ethics Committees)
- Pre-clinical study documentation (including protocols and data collection forms) for IACUC submissions
- Management of international CROs responsible for OUS clinical site monitoring
- Clinical protocol development, including Case Report Forms, Informed Consent, and trial agreements
- Clinical report writing
- U.S. regulatory submissions support (e.g., pre-IDE packages, IDEs,
510(k)s, and PMAs)
- Clinical and regulatory support for Design Dossiers and Technical Files for CE Marking
PAST COMPANIES AND EXPERIENCE
Katrina began her career in veterinary medicine at the University of California, Davis as an emergency care nurse and as a veterinary anesthetist for large and small animals. After seven years, she transitioned into the medical device sector to support pre-clinical research and to serve as a clinical instructor for product training of surgical teams. She held management positions at Heartport, Converge Medical, RITA Medical and AngioDynamics, and she maintained responsibility for all aspects of pre-clinical and clinical programs, including laboratory studies, (site selection, study management, and oversight), clinical protocol development, and investigator training.
EDUCATION
Katrina earned her BS in Biology from Sonoma State University. She holds a post-graduate Clinical Trials Design and Management certificate and is also a Registered Veterinary Technician (RVT) and a Registered Laboratory Animal Technologist (RLATG). |
