Expertise

We have experience of designing, interpreting and reporting a wide range of clinical studies across multiple therapeutic areas.

Furthermore, we have particular expertise in Phase 1/Clinical Pharmacology studies in both healthy volunteers and patients. Examples of the types of studies we have been involved in include:

Phase 1 picture of some tablets in a packet  

  • First-In-Human Dose Escalation Studies
  • Food and Formulation Effects
  • Thorough QT Studies
  • Renal Impairment
  • Hepatic Impairment
  • Drug-Drug Interactions
  • Bioequivalence
  • Mass Balance
  • Absolute Bioavailability

 

Phase 2a/b and 3 picture of some capsules in a packet

  • Exploratory and Pivotal Efficacy Studies in Patients
  • Biomarker Studies
  • Pediatric Studies