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