Early Clinical Development
When success rests on nailing the right target, right patient, right dose and right time
We offer early-phase expertise to help you make critical decisions based on insights and evidence, not guesswork. D2V Clinical is skilled in dose optimization strategy, translational medicine, clinical pharmacology and pharmacometrics, clinical study protocol design, targeted indication identification, safety and efficacy signal detection, and FDA interaction.
Ensuring a sound, valid study design and dose selection
Optimizing site selection: right site with right patient population
Valuing and simplifying the patient journey
Collaborating with KOLs
Achieving timeline expectations
Determining asset value, current market relevance and compound market position
Trust our pharmacology experts with these early development focus points
- First-in-human (FIH) study design
- Dose-finding / dose optimization studies
- Pharmacokinetic/pharmacodynamic (PK/PD) studies
- Bridging studies
- Food effect studies
- Drug-drug interaction (DDI) studies
- Exposure response analysis and organ impairment studies
- Multiple Ascending Dose (MAD) studies
- Single Ascending Dose (SAD) studies
- QT studies
One of our first priorities when helping a client in Phase I is to help them find the maximum tolerated dose, or MTD. This is the highest dose that can be given and still be safe and effective for patients. We are committed to excellence in early-phase studies because if you get things wrong, it can cause issues down the line. No one wants a Phase III failure. The right dose is an essential parameter for successful development.