Phases of
Early Clinical Development
Early development clinical trials are crucial in the drug development process, primarily focusing on assessing the safety, tolerability, and initial efficacy of new medical treatments. These trials typically encompass Phase I and Phase II studies.
- Objective: To evaluate the safety of a drug in humans, determine pharmacokinetics (how the body processes the drug), and assess pharmacodynamics (the drug’s effects on the body).
- Participants: Usually involve 20-80 healthy volunteers or patients.
- Design: Often includes single or multiple dose-escalation studies where participants receive increasing doses to identify the maximum tolerated dose and observe side effects
- Objective: To further assess safety and begin evaluating efficacy in patients with the condition the drug intends to treat.
- Focus: Investigates optimal dosages, potential side effects, and how the drug interacts with other medications.
- Participants: Typically larger groups than Phase I, often including patients who have the condition being treated.
- Safety and Tolerability: The primary focus is to ensure that the drug is safe for human use with minimal adverse effects. SAFETY COMES FIRST!
- Efficacy Assessment: Initial signs of effectiveness are evaluated to determine whether further development is warranted.
- Regulatory Oversight: Continuous evaluation by regulatory bodies is essential; they have the final say on whether a drug can progress to later phases based on trial outcomes.
Before early development clinical trials can commence, preclinical studies using animal models or laboratory settings are conducted to gather initial safety data. Regulatory authorities like the FDA or EMA must approve this data before human trials can begin.
Early development clinical trials face various challenges, including recruiting suitable participants and managing complex study designs. Historically, about 52% of Phase I trials in the U.S. between 2011 and 2020 were deemed successful enough to progress to later stages.
Recently inspected by the US FDA (2023) and EMA (2024) with positive outcomes.
Clinical studies conducted in Romania and Moldova have been inspected by numerous European authorities, including those from France, Germany, and the Netherlands.
Experience expedited regulatory approval in Moldova—just 2 weeks with our expedited evaluation fee !!!
If the above are not sufficiently convincing please consider also:
- thousands of healthy volunteers in our own data base
- over 90% retention rate of our subjects in the studies & capabilities to enroll high number of subjects in short time