Phase I Clinical Trials

Move to first-in-human studies confidently in all major regions of the world

The first stages of a clinical trial are vital to success, and choosing the right partner is critical. At Parexel, we provide a simplified and dedicated approach to initial stage testing.

Phase I is the first time a drug will be tested in people and often involves a small group of volunteers with no underlying health conditions. Drawing equivalence between two different species, with different enzymes and biology, is technically challenging, but our translational science team takes the animal data you’ve acquired and precisely translates it into human data, resulting in a quick and reliable move to a first-in-human trial.

During the trial, our team administers testing to investigate dosage, side effects, and other safety measures. We escalate the dose in a controlled fashion, dialing in how the drug interacts with the body to see if there are any side effects and if the drug is safe and ready to progress.

Parexel Early Phase Units

We have four hospital-based clinical units strategically based in three regulatory environments around the world.

• Baltimore
• Los Angeles
• London
• Berlin

These units offer in-house scientific and medical expertise, combined with the latest in clinical and research technology. These full-service locations have a wide range of healthy volunteer and patient enrollment capabilities for your clinical development needs.

Running your trials around the world

Our phase I clinical trials are delivered through our global network of owned and partner clinics located around the world.

Whether you develop your molecule in the jurisdiction of the FDA, EMA, MHRA, or other regulatory body, our regulatory experts are ready to address the unique challenges of each. We also offer trials in China and Japan, where we have established agency relationships and a strong understanding of local requirements.

To further support your development, our clinical pharmacology, modeling, and simulation solutions combine clinical pharmacology modeling and simulation with clinical PK/PD and pharmacometrics for a more strategic approach to clinical development. We’re also industry leaders in ethnobridging, with 15 years of experience.

The most important thing we offer at this stage, however, is an experienced team who recognize the time, technology, and hope you’ve invested in your product so far, and are committed to taking it to the next phase.