Since 1996 your fastest track for Phase I trials…cross research phase I

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)