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.

Phase I
trials
  • 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
Phase II
trials
  • 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.
OTHER EARLY
Development Clinical Studies
Drug-drug interaction
Pharmacokinetic in heptic patients
Gender specificity
Food intercation
Alcohol interaction studies
Pharmacokinetic in renal impaired patients
Key Considerations in Early Development Trials
  1. Safety and Tolerability: The primary focus is to ensure that the drug is safe for human use with minimal adverse effects. SAFETY COMES FIRST!
  2. Efficacy Assessment: Initial signs of effectiveness are evaluated to determine whether further development is warranted.
  3. 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.
Importance of Preclinical Studies

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.

Challenges and Success Rates

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.

Why Choose 3S Pharma as a CRO for your
Early Development studies?
Regulatory Excellence:

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.

With over 25 years of experience, a dedicated team of over 100 professionals, and more than 1,000 registered studies, we are committed to delivering high-quality results that meet your research needs.
Fast-Track Approvals:

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
Have we convinced you?

Please contact us at
3S-office@3spharma.net our call us !!!