Pharmacodynamic Studies for CNS, Oncologic and Metabolic Disorders

Pharmacodynamic studies for CNS, Oncologic and Metabolic Disorders are CRST’s core competence, but CRST has experience and knowledge also in many other therapy fields. CRST’s experience ranges from early phase I-IIa pharmacodynamics and -kinetic studies to phase II-IV multi-centre studies.

Molecular biomarkers in biological fluids, imaging biomarkers and clinical physiological or neuropsychological measures are employed as surrogate endpoints in pharmacodynamic studies.

For pharmacodynamic studies, CRST provides an all-round package which comprises:
• Medical and scientific consultation
• Adaptive study design planning
• Medical writing which includes protocol, informed consent, study report, translations plus other necessary documents
• Regulatory submissions which include preparation of documents, submissions and correspondence
• Case Report Form and source data form design
• Healthy subject and patient enrolment
• Clinical conduct of the study
• Study monitoring
• Project and site management
• Data management and statistical analysis
• Biomarker and pharmacokinetic sample analysis and PK calculations

For more information or to discuss pharmacodynamic studies for CNS, oncologic and metabolic disorders please contact us directly.