Information for Sponsors

Consultation and Trial Management

Clinical Research Centers

Contact Us

Consultation and Trial Management

Biofortis US has administrative offices in Addison, Illinois, a western suburb of Chicago. The professional services provided through our administrative offices include clinical trial consulting, trial management, project management, contract and budget design, medical writing, and data management and biostatistics.

Kevin C. Maki, PhD, President/Chief Science Officer
Tia M Rains, PhD, Director, Medical Writing/Principal Scientist

Areas of Expertise

Our extensive experience in the design and management of clinical trials enables us to evaluate functional foods, food additives, consumer health products, dietary supplements, OTC and Rx pharmaceuticals and medical devices.

- Trial Design and Consultation
- Sample Size and Power Calculations
- Statistical Programming
- Data Analysis and Presentation

- Trial Management

- Protocol Development
- Project Management
- Clinical Monitoring
- Data Management
- Statistical Consulting and Analysis
- Manuscript and Clinical Study Report Preparation

- Trial Design

- Sample Size and Power Calculations
- Statistical Programming
- Data Analysis and Presentation

Return to Top

Clinical Research Centers

Who We Are
Clinical Research Site: Addison, Illinois

Biofortis US is an independent research company specializing in clinical nutrition and chronic disease risk factor management. We develop and conduct clinical studies in the areas of risk factor modification, lipid and carbohydrate metabolism, obesity, metabolic syndrome, diabetes, men’s and women’s health.

Kevin C. Maki, PhD, President/Chief Science Officer
Andrea Lawless, MD, Clinical Research Investigator
Kathleen Kelley, MD, Clinical Research Investigator

Site Capabilities

Biofortis US operates a research clinic in Illinois.
The Addison clinic is located in a northwest suburb of Chicago within an ethnically diverse community and in addition, the clinic is only 12 miles from Chicago’s O’Hare International Airport and short distance from 3 major expressways. The population in the ‘Chicagoland’ area is approximately 9,700,000.

Regulatory
A regulatory specialist works closely with the site and sponsors to process and submit all trial related regulatory documents, tracking the progress of each submission through to completion.

Recruitment
Biofortis US meets or exceeds trial enrollment goals using its extensive database of study volunteers, print media as well as radio and electronic advertising. We have a fully dedicated recruitment staff to tailor subject recruitment for each trial to meet our enrollment goals.

The recruitment specialists work with the sponsor to develop a recruitment plan for each trial and study specific advertising materials.  Our study subject database allows us to keep in regular contact with potential study participants. The recruitment team works together with trial coordinators to track enrollment progress and to modify and update the recruitment plan as needed.

Return to Top