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 three floors of flexible research rooms, hotel-like long-stay accommodation and a dedicated first-in-human unit with ICU setting – is fully dedicated to executing 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 are trained regularly in basic and advanced life support. In addition, the ER of the Leiden University Medical Center is located within 300 metres of our facility.
CHDR operates as a one-stop-shop, providing a full range of services:
Recruitment
With an innovative, strategic approach, CHDR’s Recruitment Department rises to the challenges of recruiting healthy volunteers and patients for a wide variety of study requirements.
Pharmacy
The GMP-licensed pharmacy of the Leiden University Medical Center is our full-service partner in early-stage clinical research. The LUMC pharmacy prepares and delivers pharmaceutical products, including investigational medicinal products, and offers tailor-made solutions to help answer our sponsors’ questions.
Regulatory affairs
CHDR takes an active approach to ensuring ethical practices in research. We provide all the services needed to optimise the development of a new protocol and streamline the approval process.
Biomarker Engineering and Analytics
Biomarkers are crucial for understanding the efficacy and safety of novel drugs in clinical trials. The Biomarker Engineering and Analytics (BEA) group is engaged primarily in the development of new measurement methods that generate biomarkers to quantify drug effects in human volunteers. Our group brings together research professionals with a range of expertise: electrical and biomedical engineering, technical medicine, data science, (cognitive) neuroscience, and validation processes.
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.
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.
Pharmacokinetics and pharmacometrics
Over the past decade, CHDR’s 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.
Data management
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.
Trial@home
Trial@home, CHDR’s dedicated strategy for off-site clinical trials, enables investigators to collect information as trial participants go about their day to day activities.
