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 therapes and CEC in the cardiovascular, pulmonary and central nervous system fields.

Defining the Clinical Pathway for the Emerging Valve Space

Designing and executing a pivotal clinical trial for a small emerging device company

The DAPT Study: A Case Study in Collaboration

The Dual Antiplatelet Therapy Study (DAPT) was a landmark clinical trial which we designed and managed, with the objective of determining the appropriate duration of dual antiplatelet therapy following placement of a drug-eluting coronary stent.

Drug Eluting Stents and Stent Leadership

In the early days of the Drug-Eluting Stent market, we were turned to by many start-up enterprises 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.

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 (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.

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 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.

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 patient retention

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.