The Baim Institute for Clinical Research is a non-profit academic research organization (ARO), based in Boston, but with experience in research that spans the world. Our team delivers insight, innovation, and leadership to develop creative solutions that reduce the obstacles to implementation and enrollment of clinical trials. We collaborate with the world’s leading researchers from national and international institutions to design, implement, and complete clinical trials, and then develop programs to translate the results into clinical practice.Our entire team is fiercely committed to finding creative solutions and delivering timely research that helps advance health and quality of life around the world.
Baim Institute’s mission is to improve health and quality of life by collaborating with academic health systems, industry partners, and patients to conduct high-quality clinical research in a professionally nurturing, inclusive, equitable, and world-class academic environment.
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. At 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.
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 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.
Experience with FDA
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.