Our experience spans a wide range of clinical trial designs and methodologies. From early-phase trials, randomized clinical trials, to real-world evidence generation, the Baim Institute partners with sponsors and investigators to advance high-quality, scientifically rigorous studies that inform practice and improve patient outcomes.
From emerging drug, device, or diagnostic start-ups to established pharmaceutical, device, and diagnostic companies, the Baim Institute collaborates across the full research continuum—from study conceptualization, discussion, and design to randomized clinical trials through implementation science programs, outcomes research, and economic analyses. We welcome the opportunity to discuss your study needs.
Since its founding in 1993, the Baim Institute has operationalized hundreds of clinical trials, many of which have contributed to the FDA approval of novel drugs and devices. Our services encompass both comprehensive trial management and targeted support, including event adjudication and arrhythmia core laboratory services.
The Baim Institute has extensive experience engaging with the FDA. This includes supporting trial design and protocol development, providing statistical services, and assisting with FDA interactions and responses. This depth of experience provides sponsors with confidence that Baim understands the complex regulatory requirements of clinical research and can serve as a knowledgeable and reliable partner in the development of new therapies and technologies.
Registry studies provide valuable insights into patient populations, treatment patterns, and outcomes. Apart from traditional registries, Baim has been a pioneer in direct-to-participant registries, allowing data to be collected directly from patients via internet, mobile applications, mailed surveys, telephone calls, or other means. The Baim Institute has partnered with professional societies and industry collaborators to design, implement, and manage registries. Our approach emphasizes streamlined processes, timely data return, and dissemination of findings to inform clinical practice and improve patient care.
Post-marketing studies, whether required or voluntarily undertaken, collect additional data on safety, effectiveness, and optimal use once a product is approved. The Baim Institute works closely with sponsors to design and execute post-marketing programs that meet regulatory commitments and generate meaningful real-world evidence.
Outcomes research evaluates the impact of treatments and interventions on patient health, quality of life, and healthcare utilization. The Baim Institute applies rigorous scientific and operational standards to all outcomes studies, ensuring that findings are robust, reproducible, and clinically relevant. Our goal is to generate evidence that informs practice and improves the health and well-being of diverse populations.
As a not-for-profit academic research organization, the Baim Institute is committed to conducting research that advances science and clinical knowledge. We actively participate in government-funded studies that are designed not for product registration or approval, but to address critical questions in medicine and improve public health.
The Baim Institute provides an academic environment that fosters scientific inquiry and innovation. Our faculty investigators regularly generate new research questions and concepts that lead to the design of original clinical studies. We frequently partner with industry collaborators to secure support for investigator-initiated trials, including smaller or hypothesis-generating studies, which Baim is fully equipped to operationalize.
Health economic research plays a vital role in translating clinical outcomes into real-world value for patients, providers, and payers. At the Baim Institute, we design and implement studies that evaluate the cost-effectiveness, cost-utility, and budget impact of novel therapies, devices, and care delivery models. Our multidisciplinary team integrates clinical data, quality-of-life measures, and resource utilization to generate insights that inform policy, guide reimbursement decisions, and support the adoption of evidence-based practices. Whether embedded within a clinical trial or conducted as a standalone analysis, our health economic studies help stakeholders understand the clinical and economic value of innovation across the continuum of care.
The Baim Institute also collaborates on a variety of other study designs, including: