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Special populations, biomarkers and surrogate parameters
Investigations in special populations of healthy subjects or patients have recently become the
focus of attention. By including patients with the target indication in early phase clinical
trials, useful information relevant to therapeutic use can be obtained and the development
process shortened thereby. Furthermore, clinical studies in patients with risk factors e.g.
those with impaired organ function can be performed in order to increase drug safety.
Special populations used by SocraTec R&D
We are experienced in carrying out studies in the following populations:
healthy volunteers
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patients with
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elderly subjects
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impaired renal function
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postmenopausal women
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impaired liver function
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inflammatory bowel diseases
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cancer
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chronic pain conditions
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chronic obstructive pulmonary disease
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Range of experience
Predicting therapeutic efficacy based on the doses administered or drug concentrations measured in
biological compartments is a key element in the development of innovative drugs. Studies involving
the determination of therapeutically relevant clinical end-points or surrogate parameters are the
foundation for obtaining a reliable extrapolation supported by PK/PD-modelling.
SocraTec R&D is experienced in projects involving patients with
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metabolic diseases,
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diseases of the blood,
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diseases of the central nervous system,
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cardiovascular diseases,
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urological disorders and
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acute and chronic pain.
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The evaluation of pharmacodynamic effects and clinical endpoints during therapy is often done by
means of questionnaires or diaries. This may however, be combined with more objective measurements
of the changes in body functions. Our collaboration with the City Hospital in Erfurt and institutes
of the University of Jena allows us to employ state-of-the-art procedures for determining drug
efficacy in accordance with the specific requirements of a study. Take advantage of our experience
and benefit from this flexibility in clinical methodology.
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