Clinical Research
The Baim Institute conducts high-quality and high-impact research to improve patient care and inform public health guidelines and treatment standards around the world.
Expertise across medical fields
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 therapies, and CEC in the cardiovascular, cardio renal liver metabolic (CRLM), and central nervous system fields.
Device
CEC
Drug
Other
Device
Defining the Clinical Pathway for the Emerging Valve Space
Designing and executing a pivotal clinical trial for a small emerging device company.
Drug Eluting Stents and Stent Leadership
In the early days of the Drug-Eluting Stent market, many start-up enterprises turned to Baim to design their IDE DES clinical trials, as a clear pathway for these emerging devices was lacking at the time.
Leadership in Trials for Other Novel Devices
Beyond our leadership in stent and valve trials, we have served in a critical role for numerous other types of first-in-class and best-in-class devices, beyond bare metal and drug-eluting stents.
CEC
Creating a Clinical Event Committee in a New Therapeutic Area
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.
Event Identification for a Large and Complex Global Study
Within the landmark DAPT 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.
Assessing Adjudication Quality
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.
Establishment of an Emergency CEC Panel to RESCUE a Study
When it was clear that an existing CEC adjudication process by a different organization was not able to process the number of endpoint events to meet the sponsor’s expected timelines, the sponsor approached Baim and asked us to adjudicate over 4,000 events within a seven-month window to complete all adjudications prior to database lock.
Drug
Academic Site Engagement
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 participant retention.
Other
Health Economics and Quality of Life
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.
Biomarkers in Heart Failure
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.