Pre Clinical Study Management

CVO-EUROPE places at your disposal their experts and R&D project managers in order to help you in your pre-clinical studies.

 

Our offer

Strategy and Planning

  • Determining the goal and objectives of the pre-clinical study
  • Defining the regulatory context
  • Identification and validation of Therapeutic Targets
  • Planning of Safety and Efficacy Studies
  • Coordination of implied services (R&D, toxicology, pharmacology, laboratory analysis…)
  • Data analysis and decision making on the future of the test molecule

Operational Aspect

  • Formulation of the test molecule
  • Determining the physicochemical properties
  • Safety Studies: selection of used models/species, number and sex, tested doses and form of administering, immunogenicity
  • Efficacy Studies: Metabolism, Pharmacodynamics, toxico-kinetic, pharmacokinetic, TA, TC, local tolerance, genotoxicity,  carcinogenicity, reproduction toxicology ( in-vivo, in-vitro methods)
  • Preparation of samples (biological environment including urine, blood, plasma), qualitative and quantitative dosages (LC / MS / MS, LC / UV) of the test molecule and its metabolites
  • Characterization of molecules: studies of pharmacokinetics (AUC, Tmax, Cmax, volume of distribution, clearance), studies of bioavailability and toxico-kinetics (DL50, NOAEL)
  • Metabolic profile: identification of the in vitro and in vivo major  metabolites for each species
  • Realization of stability studies on the test molecule
  • Statistical analysis of all collected data
  • Preparation the preclinical study report

 

Training

  • B25 - Good practices in terms of preclinical laboratory trials:  Compliance, QA and Auditing
  • A11 - Information System Validation
  • A131 - Validation of the Analysis Methods

 

Auditing

  • BPL OCDE, 21CFR58 Quality system compliance auditing
  • Study protocol auditing
  • Study report auditing
  • Inspection of the fabrication and characterization phases, stability of trial elements
  • Supplier auditing: CRO (qualification site), systems, hosting
  • Computerized systems auditing
  • FDA Mock Inspection and site preparation