Expertise & Experience

Since 1984, ATC has developed in its clinical pharmacology unit (UPC) a high expertise in Early phase clinical trials (0, I and II). Hence, UPC offers to its customers a professional and scientific support to the conducting of clinical trials and to the decision making processes during the early phases of theirs new molecules’ development. 

CLINICAL EXPERTISE

  • Exploratory Clinical Trials (eCTA)
  • First-In-Man
  • Bioequivalence
  • Bioavailability (pK, pD)
  • Cardiac safety (QTc)
  • Food interaction
  • Drug interaction
  • Proof of Concept (Efficacy/Tolerance)

Note:  Within these types of trials, UPC has experience in:

  • Different and complex study designs (cross-over, double blinded, single ascending dose, multiple doses, multiple ascending doses, parallel arms, etc);
  • Biotechnology (e.g. monoclonal antibodies).

Besides, UPC has developed experience in conducting Phase III clinical trials, including efficacy and safety tests, biomarkers, hormonal modifications and metabolism (pK, pD).

MEDICAL EXPERTISE

  • Diabetes, nutrition and metabolic disorders;
  • Privileged access to the medical expertise of the CHU of Liège (Sleep center, Pain Clinic, Endocrinology, Cardiovascular diseases, Pneumology, etc).

TECHNICAL EXPERTISE

Routine techniques:
  • Biological samples collection (blood, urine, feces);
  • Vital signs (temperature, blood pressure and heart rate, respiratory rate) ;
  • ECG and cardiac monitoring;
  • Telemetry (cardiac monitoring, vital signs, CO2);
Specific techniques:
  • Clamps:
    • Hyperglycaemic (insulin production assessment);
    • Euglycaemic-Hyperinsulinemic (insulin sensitivity assessment)
  • Microdialyse (in development);
  • Privileged access to the technical expertise from the CHU of Liège (such as the Cyclotron, the GIGA, the CIP, the Sleep center, the Pain clinic, etc).

NON CLINICAL EXPERTISE

  • Medical advice and administrative support to the study protocol writing;
  • Writing and submission of the files to the EC;
  • Quality Control.