We draw upon the clinical trial expertise of our professional staff, as well as our affiliated academic research faculty, to support all stages of clinical research for devices, drug therapes and CEC in the cardiovascular, pulmonary and central nervous system fields.
In a recent study with cardiac endpoints, we were unexpectedly required to review and adjudicate approximately 250 deaths non-cardiac deaths for a possible association to cancer. This work needed to be completed within three weeks to meet a deadline for presentation at a major scientific conference.
Within the landmark DAPT Study (see related Case Study), our Clinical Events team faced a number of challenges that had to be overcome in order to complete the study for all of the eight funding companies and the FDA.
Our Clinical Events Committee (CEC) team has been adjudicating events for years and has created processes that have been adopted by many other AROs and CROs.
When it was clear that an existing CEC adjudication process by a different organization was not going to be able to process the number of endpoint events to meet the sponsor’s expected timelines, the sponsor came to the Baim Institute and asked us to adjudicate over 4,000 events within a seven month window to complete all adjudications prior to database lock.
Large global clinical trials are a necessary step in clinical development for most pharmaceutical therapies but these studies often encounter challenges that have a substantial impact on timeline and budget; two critical elements for sponsors. The most common issues relate to the timeline for enrollment and the impact of suboptimal patient retention
Many sponsors seeking for approval for innovative, first-in-class medical devices have found that Economic and Quality of Life (EQoL) studies can be a valuable asset in the overall commercialization process.
Heart failure (HF) is a leading cause of morbidity and mortality worldwide. HF is the underlying cause of >55,000 annual deaths in the US, and the cause of > 1,000,000 annual hospital visits.