We would look for solutions allowing an accelerated and smooth start of your FIH study.
Increased insights can help you further optimize the start of your clinical program and address additional questions that may arise:
How can I determine acceptable clinical endpoints and ultimately finalize the study protocol?
Which data do I need to file a EU Clinical Trial Application/ US Investigational New Drug Application?
How do I align my CMC and nonclinical plan with my clinical endpoints?
How can I identify clinical investigators with the necessary expertise and capabilities to conduct the study?
With our flexible approach we can even assist you in identifying and project-managing a Clinical Research Organization able to run the study, capture and analyze the data and write the Clinical Study Report.