Study Types

From fledgling drug, device, or diagnostic start up to big pharma and major device or diagnostic company, we can work with you across the research continuum from Phase 2 through implementation science programs, outcomes research, and economic analyses. Talk with us about your study needs.

Research areas where we excel:

Phase 2 and 3
Since our inception in 1993, Baim has operationalized hundreds of clinical trials, many leading to FDA approval of drugs or devices. The services performed on these trials varied from complete trial execution to a portion of the study, i.e. event adjudication or arrhythmia lab services. We have interfaced with the FDA, supported our studies at FDA advisory meetings, defended study designs and created familiarity between Baim and FDA; they know us. This experience provides sponsors with the confidence that Baim recognizes the requirements of clinical trials and can be the partner for the drug, device, or diagnostic.

Government-Funded

As a not-for-profit academic research organization, a component of The Baim Institute’s mission is to perform clinical research that is purely academic in nature.  Baim participates in many government-funded studies whose goal is not registration, approval, or clearance of new products, but rather the advancement of knowledge within the scientific and medical communities.

Registries and Post-Marketing

Compared to a clinical trial, registry studies offer a lower-cost option to learn about particular patient populations and trends. The Baim Institute has worked with professional societies and industry registries. Our approach to registries has evolved and been streamlined. Rapid return of data to our partners and sharing that with the medical community are important to improving outcomes.

Post-marketing study commitments are sometimes required of or agreed to by a sponsor after the FDA has approved a product for marketing. These studies gather additional information about a product's safety, efficacy, or optimal use. We can work with your company to satisfy and exceed your post marketing requirements.

Outcomes

Outcomes research strives to analyze the effects of a treatment on a patient’s life, thereby providing guidance to clinicians and other healthcare practitioners in making decisions regarding patient care. The Baim Institute has participated in a wide range of outcomes studies, and we apply the same scientific and operational rigor to outcomes studies that we do for all research activities, with the ultimate goal of improving the health and quality of life of the population.

Investigator-Initiated Studies

The Baim Institute provides an environment where scientific curiosity and investigation can be fostered. Our faculty members are all active researchers, and they are constantly generating new ideas or questions to be answered which lead to concept development for new clinical trials. We often seek pharma or device company partnerships and funding for smaller, perhaps hypothesis generating studies in which Baim can fully operationalize the trial.

Other types of trials where we can collaborate:

  •  Feasibility assessments
  •  Pilot studies
  •  Cohort studies, case control, and observational studies
  •  Screening and prevention studies
  • Multi-arm studies, where treatment groups change over time