Primum non nocere (“First do no harm”) is the principle that underlies all health care. There is no task more critical to the credibility of a pharma organization than the timely, accurate and appropriate reporting of adverse events. With both direct patient care, as well as extensive regulatory experience, Michael Kurman Consulting brings a unique and balanced perspective to the reporting of drug safety.
- Medical monitoring
- Expedited safety reporting
- Safety review
- SAE narrative/Analysis of similar events