Our approach allowing for an accelerated and smooth start of a FIH study includes:

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• Developing a study protocol in collaboration with clinical experts

• Defining clinically meaningful endpoints

• Selecting a CRO to manage the study   

• Identifying clinical sites and investigators with the right expertise and capabilities to conduct the study?

• Aligning CMC and nonclinical plan with regulatory IND/CTA requirements

• Preparing scientific advice meetings with regulatory authorities 

• Drafting the IND/CTA application

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