The Clinical Research and Regulatory Services Division oversees Phase to I Phase IV projects worldwide – from obtaining the experts’ opinion (e.g., Regulatory Agencies, KOLs…) on the most appropriate way to generate robust evidence on a medicine’s benefits and risks to developing thestudy design.
In addition, CEBIS is closely working with the pharmaceutical company along the product developing journey – from conceiving the specific documentation to regulatory & ethics approval, data management, monitoring, project management, biostatistics, and until the research results publishing.
has the expertise of performing Adaptive Designs for Clinical Trials of Drugs and Biologics
uses AI to perform clinical trial modeling and simulation, improving the efficiency of the drug development process
uses clinical trial technologies to improve milestones, to have high quality data, and to document all the activities performed
uses risk-based monitoring tools to increase the study performance
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum of information you can provide.
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CEBIS Interantional
Romania- Helios Business Center (HBC),
47 Bd. Theodor Pallady,
Bucharest, Romania