COVID-19 has presented a variety of challenges. The way people live their lives and conduct their work has been disrupted. There are restrictions that limit where they can go and what they can do, but those limitations are not confined to home life or office settings. COVID-19 has had important…

Risk assessments are often an afterthought. A company is required to be audited, and the auditor finds gaps or holes in its processes. That company then scrambles to make corrections. The auditor, as an objective third-party, may see things that the company misses or have seen more cohesive operations elsewhere…

Medicine is continually advancing. New bodily mechanisms are uncovered and understood as analytical platforms improve. It happens almost by a zeitgeist, with several locations around the world happening upon similar discoveries and subsequent researchers leveraging those findings to prompt an evolution of those understandings. The transformation manifests by a sudden…

Ventilator-Associated Pneumonia (VAP) is a common complication of mechanical ventilation. Overall, the percentage of VAP or cases of pneumonia associated with mechanical ventilation compared to the sum of nosocomial pneumonia cases is greater than 50%, with the highest incidence occurring in the ICU, where approximately 90% of pneumonia cases are…

Rare disease drug development varies from the pathways seen in more established indications. The sample sizes are often extremely small, and establishing a good base of clinical data can be difficult. Natural history studies help bridge the gap. Per the FDA, the natural history of a disease can be defined…

Personal data privacy has taken another evolutionary step with the release of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons, the General Data Protection Regulation (GDPR). If you work for an organization that is not based…

Clinical research continues to evolve. At the same time, the methodologies used to protect patient safety are changing. The techniques and strategies used in our field evolve with new technologies. New regulations and other challenges also have an impact. In 2020, the biggest influence on the way our industry operates…

Clinical trials are large complex projects, and occasionally a sponsor may need to make a change to bring an underperforming project back on schedule. This type of change is not taken lightly by sponsors. Making such a transition takes time and a large investment in coordination and additional money. In…

Cohort management is part and parcel of conducting dose-escalation studies, but not all teams effectively manage it. Pharm-Olam is focused on expediting our sponsors’ early phase cycle time in Oncology to enable rapid delivery of a mean tolerated dose (MTD)/recommended Phase 2 dose (RP2D). …