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.
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.
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.
Over the past decade, our PK data analysts and pharmacometricians have provided in-depth pharmacokinetic (PK) and pharmacodynamic (PD) analyses to support critical decisions in the development of a range of drugs. Our team is adept at performing non-compartmental analyses and population PK/PD analyses for all types of clinical studies, at all phases of drug development. Our pharmacokinetic and pharmacometric expertise is especially extensive in the field of early clinical drug development.
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.
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.
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.