The Company SocraTec R&D - In brief: services of SocraTec R&D

In brief: services of SocraTec R&D

As an independent Contract Research Organization we collaborate with both multinational research-based or generic companies, as well as medium-sized companies focussed more on national markets. Our experience and expertise comprise the following areas:

Clinical investigations in phase I and phase II

	Bioavailability/bioequivalence studies according to the CPMP Note for Guidance and the FDA Guidance for Industry
	Pharmacokinetic investigations (LADME)
	Interaction studies (drug-drug and drug-food)
	Studies with pharmacodynamic surrogate parameters and biomarkers
	Investigations in special populations, e.g. patients with impaired organ function (renal or hepatic insufficiency), post-menopausal women
	Studies in symptomatic patients, e.g. with hyperlipoproteinemia, diabetes mellitus or oncological indications
	Studies on local tolerability (e.g. skin irritation) according to US-FDA standards
	Investigations on in-vitro/in-vivo-correlations (IVIVC)

Special techniques

	Absorption-site studies by use of intestinal-tube technique
	Magnetic Marker Monitoring for gastro-intestinal Imaging (PDF-folder)

Biopharmaceutics

	Characterization of drug substances and dosage forms
	Performance of medicinal products administered to patients

Expert statements, consultation

	Conceptional consultation: from development concept to registration
	CTD: Clinical Overview, Analytical Overall Summary
	Special expert statements, e.g. biowaivers, acceptance criteria, study results

Further services

	Monitoring
	Project management