Who We Are

The Baim Institute for Clinical Research is a leading, non-profit academic research organization (ARO) that delivers insight, innovation, and leadership in today’s dynamic research environment. We collaborate with the world’s most highly respected researchers from renowned institutions to design and run clinical trials – and we are fiercely committed to finding creative solutions and delivering timely results that help advance health and quality of life around the world.

Relationships that have advanced clinical research

The origins of the Baim Institute go back to 1993, when Donald S. Baim, MD, and Richard E. Kuntz, MD, founded the Cardiovascular Data Analysis Center (CDAC) in order to provide academic insight and leadership to interventional cardiology trials. We became the Harvard Clinical Research Institute (HCRI) in 2000, formalizing our relationships with Harvard Medical School, Partners Healthcare System, and Beth Israel Deaconess Medical Center, where CDAC was first created within the Division of Cardiology. In October 2016, we changed our name to the Baim Institute for Clinical Research, after Dr. Donald Baim, a world-class pioneer in cardiovascular research. Dr. Baim’s reputation reflects our commitment to excellence, innovation, and collaboration in the pursuit of evidence-based medicine that improves patients’ lives. As the Baim Institute, we continue to collaborate with these organizations, as well as a growing network of academic researchers and institutions, to offer expertise in a range of therapeutic areas.

Today, the Baim Institute combines the operational capabilities and quality necessary to manage both large and small clinical studies, leveraging world-class scientific leadership. This approach helps maximize the attention given to, and the value derived from, every research engagement. 

Remembering Donald Baim

Donald S. Baim M.D., was a leading figure in the history of interventional cardiology, and a key contributor to both the clinical and research accomplishments in this field.

Following his training in Internal Medicine and Cardiology at Stanford University, he was recruited to the Harvard Medical School Faculty in 1981 to establish an Interventional Cardiology program at Boston's Beth Israel Hospital, now the Beth Israel Deaconess Medical Center.

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Mission & Vision

Baim Institute's mission is to improve health and quality of life by collaborating with academic and industry partners to conduct high quality clinical research in a professionally nurturing and world-class academic environment.

The Benefits of Working With Baim Institute

Collaborative Approach to Clinical Research 

The Baim Institute’s research model combines scientific and operational expertise throughout a clinical trial’s execution and analysis. We draw on faculty from multiple institutions and have close relationships with leading investigators throughout the country. This model allows optimal collaboration among sponsors and all stakeholders, often engaging thought leaders in the field from the start. The Baim Institute also partners with respected academic groups running medical registries to optimize the analysis and scientific output from our data sources and regularly collaborates with multiple AROs and CROs as part of a best-in-breed project team. 

Reputation for Quality 

Our institute offers a long legacy of respected data management and analysis.  We stress quality clinical research as our core foundation, and our quality system is designed to assure data integrity to all stakeholders. With participation and support from the Baim Institute, our faculty are widely published in leading peer-reviewed medical journals. As a result of our reputation for data integrity, we routinely provide research sponsors with validation of their statistical programming and analysis.

Independence

Independence is critical to the integrity of our study data.  The Baim Institute continually strives to maintain this independence by drawing upon distinguished faculty across multiple institutions, ensuring a diverse pool of independent scientific expertise.  This pool ensures differing opinions are considered and integrated into our research and analytics.  Our faculty, as well as our professional staff, are subject to a careful conflict of interest oversight review process before participating in any research at the Baim Institute. 


Full Operational Capabilities 

The Baim Institute has extensive expertise managing multi-center studies and we rely upon respected scientific leadership throughout the life of each study. We execute all components of clinical research from study design through site selection and statistical analysis. The Baim Institute maintains operational expertise in the following areas: 

  • Trial Design
  • Project Management
  • Site Management and Monitoring
  • Data Management, including Electronic Data Capture (EDC)
  • Statistical Analysis
  • Medical Monitoring and Oversight
  • Clinical Endpoint Event Identification and Adjudication
  • Pharmacovigilance
  • Medical Writing 

Experience with FDA Regulatory Approvals 

The Baim Institute has consistently worked with the FDA and our sponsors to help design and execute efficient studies for the evaluation of new therapies.  As a result, our faculty has participated both in pre-submission meetings and panel meetings to discuss study designs and results.  We have participated in more than 50 Investigational Device Exemption (IDE) approvals for new devices and new indications for approved devices.  In addition to approvals, we have also contributed study, statistical, and adjudication data included in more than 100 FDA submissions. 

History

The Baim Institute for Clinical Research was originally formed as the Cardiovascular Data Analysis Center (CDAC) at Beth Israel Hospital in 1993.  With rapid growth in the late 1990s, we became a stand-alone organization, the Harvard Clinical Research Institute (HCRI) in 2000, and expanded our relationships to all five Harvard teaching hospitals.