CHDR's vast range of methods and biomarkers in early clinical drug development
CHDR has devoted much of its own research to drug development methodology. Through systematic reviews, dedicated studies, academic networks, and its own expertise and collected database of 25 years of drug studies, CHDR has validated and optimized a unique set of methods and biomarkers, aimed to address every major question in early drug development. Methods are carefully selected to determine whether the drug reaches its pharmacological target, how it exerts its mechanism of action, how it affects relevant (or potentially advertent) physiological pathways, and whether there are indications for therapeutic effects. Methods that are found to be closely linked to the drug, can be incorporated in every study in healthy volunteers and patients. In this way, a unique coherent dataset is generated that can be used to optimize study designs and analyse study outcomes, and to offer increasing confidence in the drug’s activity or explain unanticipated findings.
CHDR’s large experience with biomarker research and method optimization can also be used to identify or develop new methodologies, which can be tailor made for a drug with an innovative mechanism of action or therapeutic indication. Such services can include development of laboratory analyses, pharmacological of physiological challenges, imaging techniques and PET ligands, and many more.
- Continuous cardiac monitoring
- 12 lead ECG
- Vital signs
- Standard blood biochemistry
- AE’s & SAE’s