Published inPharm-Olam·May 5, 2021Recent Milestones in Rare Cancer ResearchCancer research has evolved exponentially over the last two centuries. The first time radiation was used to cure cancer happened in 1903. Less than 100 years later, cancer preventatives were receiving approval. However, rare disease is more involved. In our last article, we looked at rare cancer research in detail…Rare Disease4 min readRare Disease4 min read
Published inPharm-Olam·Mar 17, 20218 Strategies for Navigating Clinical Studies During COVID-19COVID-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…Covid-194 min readCovid-194 min read
Published inPharm-Olam·Jan 20, 2021Risk Management: Foundation for Better Project Management | Pharm-OlamRisk 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…Risk Management3 min readRisk Management3 min read
Published inPharm-Olam·Jan 13, 2021What is the Difference Between Microbiome and Microbiota?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…Microbiome3 min readMicrobiome3 min read
Published inPharm-Olam·Jan 6, 2021Understanding the Connection Between COVID-19 and VAPVentilator-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…Covid-194 min readCovid-194 min read
Published inPharm-Olam·Dec 30, 2020Importance of Natural History Study to Rare Disease Drug DevelopmentRare 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…Rare Disease5 min readRare Disease5 min read
Published inPharm-Olam·Dec 23, 20205 Key Considerations Non-EU Based Sponsors must have for GDPR Compliance in Clinical TrialsPersonal 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…Gdpr Compliance5 min readGdpr Compliance5 min read
Published inPharm-Olam·Nov 25, 2020Understanding the 3 Types of Clinical Trial MonitoringClinical 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 Trials5 min readClinical Trials5 min read
Published inPharm-Olam·Nov 11, 2020Completing a Rescue Study Transition — How Much Time Do You Need?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…Rescue Study6 min readRescue Study6 min read
Published inPharm-Olam·Nov 4, 2020Effective Cohort Management in Early Phase Oncology TrialsCohort 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). …Clinical Trials6 min readClinical Trials6 min read
