Exploratory Clinical Trials

Early demonstration of a drug candidate's relevance often gives you key information on how or whether to proceed with development. With our exploratory clinical trials program, SGS pharmacology experts will help you collect vital information as soon as possible in the process: often during the pre-IND stage, phase 0 clinical trials and at the early proof of concept stage.

When you need to demonstrate the human relevance of preclinical pharmacology, you need a partner with proven clinical trial experience. We offer an exploratory IND study approach to minimize preclinical and clinical investment, administering limited exposure doses predicted to elicit pharmacology, without safety issues. By using our trusted, tested approach, you will uncover important information such as an assessment of the mechanism of action in humans, and pharmacokinetics and interaction with a particular therapeutic target.

Our exploratory trial management includes:

• Microdosing
• Proof of concept/mechanism
• Biomarkers
• Viral challenge studies

Microdosing Services

Our clinical facility is fully authorized for C14 and to conduct AMS microdosing trials. Within SGS’s infrastructure, we can prepare and formulate C14 radiolabeled compounds under full GMP control. Also, for PET microdosing studies, specialized contracted laboratory facilities have a cyclotron for producing radionuclide and are certified for radionuclide labeled drug synthesis.

Proof of Concept/Mechanism

SGS has been working in early compound development for many years. Over that time, we have gained unique expertise in early proof of concept clinical trials in the following areas:

• Asthma challenges (exercise, metacholin, allergen)
• Insulin tolerance (modified)
• 24-hour holter ECG qualitative and quantitative
• Platelet aggregation (ex vivo)
• Brain receptor occupancy (PET)
• Pain models: GTN-induced migraine, cold pressor
• Cardiac telemetry
• Psychometric tests (computerized)
• Coagulation - thrombolysis tests
• Cerebrospinal (CSF) fluid sampling
• Pupillometry (static and dynamic)
• EEG including spectral analysis and polysomnography
• Spirometry
• Erectile function
• Stress test
• Glucose tolerance (plasma/oral)
• Skin blisters
• GTN-induced hypotension
• Visual field

Biomarkers

Biochemical markers can efficiently support the clinical trial assessment of drug candidates during Phase I, Phase II and Phase III trials.

Our GLP accredited immunoanalysis laboratory can offer you validated immunoassays for a number of biochemical markers. Thanks to our policy of expansion and improvement, the list of assays available is constantly being updated and covers a wide variety of therapeutic areas.

Contact SGS today to learn how we can help with your early phase exploratory clinical trials.

Exploratory DevelopmentExploratory Development to Proof of Concept Integrated services reduce time to market (PDF 876KB) ...

• Translational Research/Medicine

  Shifting in-human trials earlier in research (PDF 113KB)
  Translational Research (112 KB)
• Multicenter Studies in Eastern Europe

  Conducting clinical trials in the Czech Republic (PDF 330KB)
  Multicenter Studies (329 KB)
• Cerebrospinal Fluid Sampling in Phase I

  CSF sampling for PK data, biomarkers and more (PDF 403KB)
  Cerebrospinal Fluid Sampling (403 KB)

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