The added value of science in early phase drug research
We provide a full spectrum of high quality clinical pharmacology services to the (bio-) pharmaceutical industry. Our main focus is to perform data-intensive, early phase, clinical studies where pharmacokinetic and pharmacodynamic parameters are obtained and combined. We also conduct our own research, aimed at the development of biomarkers, methodology and technology under strict GCP conditions.
Thanks to our self-funded research programs and our close links with various high-ranking university research groups, we are able to obtain a wealth of data from a small sample of subjects. In early phase studies, we go far beyond the required safety measurements. The high-quality information we obtain in these studies helps companies to shape their policies regarding further testing, future use of the compound and exploring the available marketing strategies.
CHDR is organised in three research units:
The kind of studies we specialise in are:
To obtain PK/PD parameters we develop, validate and use the latest techniques to provide the most accurate and highest quality data in early phase drug development.
The methods employed by CHDR’s principal research divisions can also be applied in integrated studies in healthy volunteers and patients. In this way, the value of biomarkers is tested and optimal information about the drug’s characteristics in health and disease is generated. Specific populations include, among others, elderly and obese subjects and patients with diabetes, sleep disorders, pain syndromes, etc. Special mention should be made of drug research in children. We are adapting the techniques that were developed in adult drug studies to applications in children, both healthy or with certain medical conditions. As you are aware, research in children is becoming increasingly important in the field of clinical pharmacology. CHDR closely collaborates with leading clinical groups in these combined studies.
CHDR'S SPECTRUM OF FULL SERVICES
We provide medical writing services for protocols, informed consent forms, interim and final reports, and services related to regulatory filings to IRB and competent authorities, including pharmacovigilance, data management and monitoring, and archiving. In-house capabilities for safety analyses, PK-PD analysis ensure a rapid turn-around of data review to facilitate timely decision making.
- Medical writing
- Study execution
- Data managment
- Routine and special labs
- Quality Assurance
- Regulatory filings