Early phase clinical pharmacology trials are a vital part of the drug development process. They provide information on a compound’s safety and pharmacokinetic profile and can deliver profound clinical data on pharmacodynamic activity and potential efficacy – ‘proof-of-concept’ (POC). This helps the developer to assess the probability of the compound successfully reaching the market.
We provide advanced design and execution solutions for complex exploratory and clinical pharmacology trials. Our experts can combine a variety of first-in-human (FIH) trial types – single ascending dose (SAD) and multiple ascending dose (MAD) – into one design (combined and adaptive protocols), which can also be modified to cover the effects of food, gender, drug-drug interaction and age.
Why choose services from SGS?
With over 40 years of experience in conducting clinical pharmacology trials, we are the industry choice for exploratory phase I up to POC with biomarker exploration and special pharmacodynamic assessments. Trials include pharmacological challenge models and controlled human infection models (CHIM). Other regulatory phase I trials, including drug interaction studies, BA/BE studies, or pivotal TQT prolongation trials, can also be embedded in FIH designs.
SGS is recognized as the benchmark for quality and integrity in clinical pharmacological research. Our comprehensive range of services will ensure you receive the qualitative clinical data you need to make ‘go/no go decisions’ regarding the viability of any compound under consideration.
SGS House - Noorderlaan 87, (RPR Antwerpen BTW BE 0404.882.750),
2030,
Antwerp, Belgium