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Our team has extensive global experience in pre-clinical and clinical trial management for medical devices. Experien Group executives and directors have managed numerous clinical studies in the United States, Europe, Asia, the Pacific Rim, Canada, and Central and South America. Our staff’s expertise encompasses all elements of pre-clinical and clinical work, from animal and cadaver studies to early human feasibility trials and pivotal trials for commercial approval.
Experien Group is well staffed to help clients formulate and execute their pre-clinical and clinical strategies. Our services include:
 Pre-Clinical Research
- Identify and audit pre-clinical laboratories/facilities
- Determine requirements for acute/chronic animal testing
- Review biocompatibility and performance testing
- Provide support for cadaver testing
- Develop pre-clinical protocols and data collection forms
- Perform Study Director activities
- Prepare pre-clinical reports and study updates
Clinical Research
- Develop comprehensive clinical strategies and study designs from First in Man to pivotal studies
- Perform comprehensive literature searches
- Develop clinical protocols, Informed Consent and Case Report Forms
- Organize investigator meetings
- Perform U.S. and O.U.S. site selection, site training and site initiation visits
- Prepare IRB/Ethical Committee submissions
- Perform clinical monitoring, site audits and Bioresearch Monitoring audits
- Perform comprehensive clinical study management
- Prepare clinical study reports
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