When Medical Coding Becomes a Bottleneck: Lessons From a Real Clinical Study
From the Confidence Medical Affairs Desk by Ekaterina Shilova Medical coding challenges are often discussed from a theoretical perspective, including inconsistent terminology, free-text entries, fragmented analyses, or delayed queries. However, the operational impact becomes much clearer when these issues unfold in a real study environment. A recent clinical study demonstrated how quickly coding review can […]
Managing Clinical Trials During Investigational Product Shortages: Keeping Patients Safe When the Unexpected Happens
Drug supply planning is an established part of clinical trial management, but shortages create a different type of operational challenge because the product that becomes unavailable may not be the investigational product at all. This is particularly relevant in oncology, where an investigational therapy may be administered in combination with an approved treatment, but it […]
Medical Coding Is Not Just Data Management. It’s a Medical Responsibility
From the Confidence Medical Affairs Desk by Katarina Nedman Medical coding is often perceived as a technical or data management activity performed somewhere in the background of a clinical trial. In reality, coding decisions play a far more significant role. They directly influence how clinical data is interpreted, analyzed, and ultimately presented throughout the entire […]
Risk-Based Monitoring in Fixed-Budget Trials
From the Confidence Medical Affairs Desk by Inna Nemirovskaya Concentrating Oversight Where It Protects Study Credibility In extremely low-budget, full-service clinical trials, monitoring strategy ceases to be a matter of preference. It becomes structural. When financial flexibility is absent, oversight must be designed with precision, because every monitoring decision directly competes with another operational priority. […]
Important Protocol Deviations vs. Serious Breaches: What ICH GCP E6(R3) Means for Global Trial Teams
From the Confidence Medical Affairs Desk by Tatiana Dumpis Clinical trials become more global, digital, and risk-based. One key distinction is important for sponsors, CROs, and investigators: the difference between an important protocol deviation and a serious breach. The two concepts overlap, but they are not the same. Confusing them can lead to delayed escalation, […]