Strategy & delivery of early-phase clinical development services
Preclinical/Phase 1 specialise in the strategy and delivery of early-phase clinical development services. This enables us to provide informed, timely decisions for our clients.
Our Development Solutions teams have expertise in early phase clinical research, bioanalytics, PK-PD modelling and simulation as well as the full range of supporting services. In everything we do we incorporate scientific excellence and product development strategy.
Our experts are multi-disciplinary and have the experience to address even the most demanding of drug development challenges with an uncompromising focus on completing projects on time, within budget and to a standard that will always shine under even the most critical scrutiny.
In this area our key services include:
• Product development consulting
• Bioanalytical
• PK/PD Modelling and simulation
• Population PK
• Data Analysis (TK, PK, PK/PD)
• Regulatory affairs strategy / submission
• Protocol design
• Medical Writing
• Quality Control/Assurance
• Pharmacodynamic Models
• Clinical studies including:
• Food effect studies |
• Dosage Regimen assessments
• Diabetic Clamp studies
• QTc studies
• First in man, dose escalation, PK/PD
• Multiple dose studies
• Drug interaction studies
• Bioavailability, bioequivilence
• Phase I patient studies
• Special population studies
• Patient studies
• Special population studies
• Proof of concept studies |
If you'd like to learn more about our current vacancies in this area please click here.