Early Phase Solutions

Where you need us. When you need us.

We operate state-of-the-art facilities in the Netherlands and North America, as well as an innovative patient pharmacology model in Central and Eastern Europe. Our harmonized laboratory facilities are situated close to clinical facilities and are configured with the latest technologies, diagnostic tools, and infrastructure required to fully support all clinical study requirements across a wide range of drugs and indications.

We also have extensive experience managing global Phase I clinical sites with healthy volunteers, including in Asia Pacific, and we routinely manage third-party clinical sites through our external site management model.

Fully supporting early phase projects from start to finish.

From protocol design to Clinical Study Report (CSR) delivery, we can meet the needs of essentially any early phase study for healthy volunteers, special populations, and early patient trials, including:

• Supporting the manufacturing and Qualified Person (QP) release of any formulation of a drug.
• Providing real-time support for pharmacokinetics (PK) and biomarker analysis.
• Facilitating shortened timelines in early development.
• Converting raw data into decision-point data for our clients.

Our early development solutions include drug development programs, exploratory clinical trials, fast track development, pain studies, patient pharmacology, and target product profiles.

Effectively executing trials in healthy volunteers and patient populations.

We conduct clinical trials in both healthy volunteers and patient populations, accommodating our in-house Phase I volunteers at our state-of-the-art Clinical Pharmacology Centers, where they are under constant medical supervision. Offering a full suite of Phase I-IIa clinical research services and a globally harmonized service, these centers also provide a large pool of more than 40,000 healthy volunteers, special equipment to monitor safety and pharmacodynamics, an in-house pharmacy, and expedited regulatory approval.

Our eight clinical pharmacology centers have the capabilities and experience to quickly randomize patients, and four of our centers are 100% dedicated to early phase patient studies, both in Europe and the US. In Central and Eastern Europe, we perform early patient trials in collaboration with our extensive network of investigators throughout the region. Our US centers specialize in the conduct and design of early-stage, patient population studies, and are therapeutically focused in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric, and infectious disease services.