Meditech Strategic Consultans
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© Inconel BV
© 2008 Inconel BV
Clinical Consulting Services


MediTech can fully develop or assist you with the development of clinical strategies to meet the requirements for your specific product. Our services include guidance for the preparation of clinical investigation plans.

 

MediTech can obtain the appropriate insurance coverage for your clinical investigations directly through European insurance brokers, at the best rates, in accordance with country-specific requirements. MediTech also can prepare or review your "Investigators Brochure" and assist you with all required applications/dossier submissions to the Ethics Committee (in accordance with applicable federal and regional requirements) as well as notifications to the Competent Authorities.

 

 




MediTech provides the following clinical consulting services:

 


Investigator and Site Qualifications

Submission to National and Local the Ethics Commitees (EC or IRB)

Notifications to Competent Authorities

Notifications to hospital managements and hospital pharmacies;

Investigator and Hospital Agreements

Clinical Monitoring

Preparation of Final Reports

Web-Based Data Management System

Statistical Analysis

Translation Services

Clinical Site Audits