Phase I Clinic Studies

FIELDS OF WORK

Phase I Clinical Trials:

  • Bioequivalence
  • Bioavailability
  • First administration in humans (single dose, multiple dose)
  • Drug interactions, food interactions
  • Special populations (geriatric, kidney failure, liver failure, post-menopausal women, obese)
  • Proof of concept
  • QTc measurements
  • Pharmacogenetics
  • Neurophysiological evaluation
  • Neuroimaging
  • Nutriceuticals/functional foods

Therapy areas phase II/III:

  • Alzheimer’s Disease - Depression
  • Schizophrenia
  • Insomnia
  • Parkinson’s Disease
  • Ulcerative colitis
  • Hepatitis C
  • Aids
  • Diabetes

SERVICES:

Integral clinical research service:
  • Clinical Drug development consulting
  • Project management
  • Protocol and informed consent design and preparation
  • Data log book design and preparation
  • CEIC license application
  • Volunteer selection
  • Patient recruitment
  • Clinical development in phase II/III trials
  • Bio-analysis
  • Data and statistics management:

Statistical analysis plan
Data blind revision
Safety analysis and statistics report
Pharmacodynamics / Pharmacokinetics analysis and statistics report
Final report preparation
Trial document filing

CHARACTERISTICS:

  • Over 24 beds and leisure/resting areas
  • ICU next to department
  • Hospital Pharmacy service
  • Project management (from protocol design to clinical report)