Trial Services

CHDR has more than 30 years of experience in performing early phase drug studies. We perform around 60 early phase clinical studies per year in both healthy volunteers and patients, of which 15 are First-in-Human studies. Our purpose built research unit, consisting of 3 floors of flexible research rooms, long stay hotel-like rooms, and a dedicated First-in-Human unit with ICU setting, is fully dedicated to accommodation of phase I studies. Studies are conducted by our highly knowledgeable study teams. More than 40 of our employees are medical doctors and all clinical staff is trained regularly in Basic & Advanced life support. Additionally, the ER of Leiden University Medical Center is located within 300 meters distance.

CHDR operates as a one-stop-shop, providing a full range of services:

Recruitment

At CHDR, both the number and intensity of studies have increased in recent years, and recruiting sufficient numbers of healthy volunteers and patients can be quite a challenge, particularly given the current high standards regarding medical ethics. However, by applying novel strategies, CHDR’s Recruitment Department rises to the challenge.

Pharmacy

The GMP-licensed pharmacy of the Leiden University Medical Center (LUMC) is our full-service partner in early-stage clinical research. They prepare and deliver the pharmaceutical products, including investigational medicinal products (IMPs), and offer tailor-made solutions to help answer our sponsors’ questions.

Regulatory affairs

CHDR takes an active approach to ensuring ethical practices in research. We develop the study protocol, submit it to a certified ethics committee and the competent authority, and communicate with the Dutch regulatory bodies.

Cardiology Services

The ability to identify adverse cardiac effects is a crucial part of early drug development. CHDR offers a wide range of Good Clinical Practice (GCP)-certified diagnostic procedures that can be tailored to meet the needs of the sponsor and satisfy the regulatory authorities.

Biomarker Laboratory

CHDR houses and operates a state-of-the-art cellular laboratory and can handle fresh samples collected from both healthy subjects and patients to measure a wide variety of cellular responses. Throughout 2017, CHDR built the new cellular laboratory almost entirely from scratch.

Data Management

With three decades of experience in innovative, early-stage clinical drug research, our data management service is known for excellent planning and organisation. Our data managers engage seamlessly with both internal and external operational teams from the start of a study until database lock, ensuring timely, high quality deliverables.