Since 1996 your fastest track for Phase I trials…
CROSS Research is licensed for Phase I studies to be carried out in healthy volunteers and special populations with the aim of assessing drug safety, kinetics and disposition; establishing kinetic-dynamic relationships; measuring drug time-course of action, identify the proper therapeutic dose regimens and fulfil the regulatory requests.
Strategic services as: centralised clinical lab, analytical labs for drug assay and pharmaceutical labs for implementing formulation technology are co-operating with CROss Alliance® on the basis of preferential contracts and long term collaboration history.
Safety studies
- Single ascending dose tolerability and pharmacokinetics, (SAD)
- Multiple dose tolerability and pharmacokinetics, (MAD)
- Local tolerability and sensitisation potential
- Photo-toxicity and photo-sensitisation
- Evaluation of gastro-intestinal tolerability of drugs assessed by: gastroscopy, colonoscopy, sugars permeability or pH-metry
- QTc prolongation studies
- Drug-drug interaction studies, (DDI)
Clinical pharmacokinetics
- Single and Multiple dose pharmacokinetics
- Bioavailability and Bioequivalence
- Effect of meal
- Effect of exercise
- Pharmacokinetics in elderly
- Pharmacokinetics in post-menopausal women
Special studies
- Skin-adhesiveness study for new patches development including objective computerised measurements
- Cations and anions binders effectiveness within the GI tract for drug development in nephropathy
- Induction of ketone bodies: a model for anti-diabetic drugs
- Cheese-effect for MAO inhibitors screening
- Medical device testing in healthy volunteers with experience in: pneumology, gynaecology, dermatology
- Studies on nutraceuticals, (ask us for more information about the fast track available for studies with these products)