In this highly competitive environment, it is essential to gain as much information as fast as possible from early phase clinical studies to make go/no-go decisions quickly and with confidence. Our scientists use industry-leading study designs that reduce time from First-in-Human to clinical proof-of-concept. This approach maximizes the amount of information gathered from one study and reduces overall costs, without jeopardizing the integrity of primary and secondary objectives.
Working with other scientists and medical experts within our company, our highly skilled team of protocol-development scientists uses cutting-edge adaptive and fusion study designs to integrate objectives that traditionally have been evaluated in multiple studies. For example, by adding a patient component to an ascending dose study, we can evaluate PK and PD activity in the target population early in the drug development stage and provide you with preliminary findings on the efficacy of the compound.
Comprehensive study design and protocol-development services include:
- Study protocols and amendments
- Feedback and review of client-provided protocols
- Consultation for study design