Clinical Pharmacology Studies

CRST has over 20 years of experience in conducting clinical pharmacology studies in healthy volunteers and patients. Our experience and expertise allow us to offer cost-efficient and flexible services. We provide tailored service solutions, adapting to the Sponsor’s requirements and priorities in the context of established regulatory, medical and scientific frameworks. We also provide the clinical pharmacology, scientific and clinical expertise required for successful achievement of study objectives. We have experience in small-molecule New Chemical Entities (NCE), biological drugs and vaccines.

– First-in-Man (FIM)

– Single and Multiple Ascending Doses (SAD,MAD)

– Food effect, gender effect, age effect

– Bioequivalence and comparative bioavailability studies

– Biologicals/Biosimilars

– Drug-Drug Interaction studies

– Mass Balance/ADME studies/radioisotope tracers for AMS (microdosing)

– Modified release formulations

– Transdermal drug delivery

– Inhaled drugs

– Pharmacodynamics and Biomarkers

– Microdosing of new PET tracers

– Phase I QT Studies: Early Precision QT (iCardiac certified site)

Studies are managed by CRST’s Chief Scientific Officer with over 25 years’ experience in early-phase clinical services and experienced project managers, qualified clinical investigators and other professionals.

CRST can provide a comprehensive regulatory and clinical service packages for clinical pharmacology studies, including:

  Medical and scientific consultation throughout the study

  Study design and planning

  Medical writing: protocol, informed consent and other required documents, study report, translations

  Regulatory submissions: preparation of documents, submissions and correspondence with Competent Authority and the Ethics Committee

  Case report form and source data form design

  Subject recruitment

  Clinical study conduct

  Study monitoring

  Project and site management

  Bioanalytics (through our partners)

  Data management and statistical analysis (through our partners)