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

  • 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

You have a pre-clinical candidate which you want to evaluate in a First-In-Human clinical study.

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