IREF Research Capabilities

Research Capabilities

Ischemia Research and Education Foundation (IREF)

Researcher At Computer IREF includes a highly integrated system of multidisciplinary professionals in the U.S. and worldwide to enable comprehensive, high quality construct and analysis of observational studies and clinical trials.

IREF has unique experience and singular expertise in perioperative and cardiovascular research in the form of:

Exclusive, large scale comprehensive databases detailing adverse events, practice patterns, resource utilization, and health economics data in representative patients;
Ongoing worldwide epidemiological studies to define in-hospital and long-term outcomes and health economics in patients undergoing cardiac and non-cardiac surgeries;
Integrated teams and technologies for study design and quantitative and qualitative data analysis.

Observational Study and Clinical Trial Design

Design of the Observational Study and Pharmaceutical Sample Clinical Trial is strategic in nature and clearly key to identifying practice paradigms, determining outcomes, and developing effective medicines and devices. As well, however, it is imperative that such studies and trials enable sensitive detection of subtle safety signals-- before exposure to large numbers of patients. IREF emphasizes the latter for it is underutilized, but critically important to the welfare of patients. Staffed by senior scientific and clinical experts, IREF Study / Trial Design typically has assembled teams to:

Define a clinical development plan
Develop statistical design
Select target population
Query database for enrollment rate based on entry criteria
Predict incidence of adverse events
Determine sample size
Develop and design protocols and CRFs

Observational Study and Clinical Trial Execution

In the implementation of complex studies and trials, the McSPI/IREF consortium provides:

Clinical development planning
Study and Clinical trial design (Phase I - IV)
Global network of experienced investigators
Investigator orientation

IREF also provides a Quality Assurance program in compliance with Good Clinical Practices, International Conference Harmonization, and Health Insurance Portability and Accountability Act (HIPAAA) policy.

Biostatistics

IREF Services IREF scientific staff specializes in helping sponsors manage and apply data effectively to design rigorous studies, and resolve problems in the development of new therapeutics and devices. IREF Biostatistics has the expertise to provide the following:

Design clinical studies
Develop study protocols and Clinical Report Forms (CRFs)
Customize statistical analysis plan, with presentation tables, figures and listings
Provide both descriptive and inferential analyses
Generate study reports for regulatory submissions
Integrated efficacy and safety analyses
Organize and coordinate Data Safety and Monitoring Board

Using IREF’s databases, IREF’s Biostatistics team also answers questions about resource requirements, cost-effectiveness, and Quality of Life that affect the development of new biopharmaceutical or medical device products.

Databases

Researchers Epidemiological database on adverse events on patients who did not receive a drug compared to those who received a drug are most valuable in designing studies for the development of new pharmaceutical and medical device products. Staffed by senior scientific and clinical staff, IREF epidemiology expertise and databases aim at the following goals:

Increase the quality of observational studies and clinical trials
Accelerate complex study / trial completion
Increase efficacy and patient compliance
Improve safety
assessment during study / trial conduct and post marketing
Reduce overall development cost
Design and implement Phase IV Safety and other outcome research