Bertino Consulting Services

Our areas of expertise include: antiinfectives, oncology, cardiovascular drugs (including antihypertensive and lipid agents), endocrinology (diabetes, obesity), urology, rheumatology (small and large molecules), nephrology, pain management drugs, psychiatry.

Bertino Consulting provides the following services to clients:

• Protocol design and review
• Consent form design and review
• Case report form design and review
• Study report writing
• Medical writing:
  • Abstracts, poster preparation and manuscripts
  • Educational material for medical professionals, representatives, lay public
  • Training manuals
  • Standard operating procedure development
  • Process document development
• Review and provide input from a clinical pharmacology and medical perspective on Confidential Investigator Brochures, Investigational New Drug applications, and New Drug applications
• Medical Monitoring for Phase I-IV studies including adverse event assessment, and interpretation of inclusion and exclusion criteria
• Evaluation of Phase I unit capability and quality, including budget reviews
• Board Certified ECG interpretation
• Statistical analyses using validated software
• Pharmacogenomic expertise with emphasis on drug metabolism
• Pharmacokinetic and pharmacodynamic expertise and analyses using validated software
• Representation at Food and Drug Administrative meetings
• Due diligence for pharmacologic compounds including financial analysis of the market place
• Legal services in the areas of medical errors, medication adverse events, toxicology and lack of therapeutic response