Phase I-IV Clinical Trials

OUR CLINICAL DEVELOPMENT EXPERTISE

The Clinical Research and Regulatory Services Division oversees Phase I to 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 the study design.
In addition, CEBIS is closely working with the pharmaceutical companies 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.
As a niche service provider, CEBIS conducts PK studies on new molecules, as well as repurposed or modified formulations. Ability to conduct Phase I studies on a patient population.
Conducting complex studies including FIH (SAD/MAD) and 505(b)2 products.

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