Product/Service

Exploratory Clinical Trial Management

Source: SGS Life Sciences Services
Often early demonstration of a drug candidate's relevance provides key information on how or whether to move forward in development.

Often early demonstration of a drug candidate's relevance provides key information on how or whether to move forward in development. Critical time points for collecting this information often lie in the pre-IND stage of development and at the early Proof of Concept stage.

When demonstration of the human relevance of preclinical pharmacology is needed SGS offers an Exploratory IND approach to minimize the preclinical and clinical investment while administering doses (limited exposure) predicted to elicit pharmacology without safety issues. This approach brings important information, e.g. assessment of a mechanism of action in humans, pharmacokinetics and interaction with a particular therapeutic target in humans.

SGS Exploratory Clinical Trials include:

  • Microdosing
  • Proof of Concept / Mechanism
  • Biomarkers

Microdosing
SGS's clinical facilities are fully authorized for C14 to conduct AMS microdosing trials. Under new infrastructure SGS can now prepare and formulate C14 radio labeled compounds under full GMP control. In addition for PET microdosing studies, specialized contracted laboratory facilities have a cyclotron for the production of the radionuclide and are certified for radionuclide labeled drug synthesis.

SGS provides exploratory human pharmacology studies in volunteer subjects including the following technologies via secured partnerships:

  • AMS microdosing study
  • PET microdosing study

Proof of Concept / Mechanism
Through working many years in the field of early compound development, SGS has gained a unique expertise in Early Proof-of-Concept trials for:

Asthma challenges (exercise, metacholin, allergen)
 Insulin tolerance, (modified)
24h 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
 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 assessment of drug candidates during Phase I, Phase II and Phase III trials.

SGS's GLP accredited immunoanalysis laboratory can offer you validated immunoassays for a number of biochemical markers. The list of assays available is constantly being updated and covers a variety of therapeutic areas.