Clinical Development

Our goal is to be there with your company during overall development of your programs. We can be involved with a design and conduct of single study; however, we believe that every study can have an impact on the overall development and that prior development will influence future decisions in a program and what types of studies are needed.

We believe that having the experience with therapeutic class characteristics of compounds, their individual aspects including the formulation, route of administration, current regulatory agencies expectations, understanding the target patient population, as well as disease indication is crucial in being able to identify the compound development issues and solutions. During our review, we focus on therapeutic class, early to late development requirements, transnational medicine as well as indication-specific issues or opportunities to be able to enhance your position with regulators, the investors and the public. We utilize our vast experience from prior drug programs as well as current interactions with regulatory agencies to determine the most important next steps in your programs development.

Types of Clinical Studies we can get involved in and bring value:

• First-in-Human/Patients (FIH/FIP)
• Single Ascending Dose (SAD)
• Multiple Ascending Dose (MAD)
• Phase I/II studies

Our Phase I, Phase II, Development, Study Design and Study Conduct Services:

• Translational Medicine
  • Preclinical efficacy/safety interpretation, Starting dose rationale
• Early and Late development
  • Study designs, protocol writing and building, CRO collaboration
• Study design and protocol development including collaboration with study centers
• Study startup activities (SIV – study initial visits)
• Robust PK analysis and standalone PK Report
• Summary presentations to management