BIOS is a JHU-based academic research organization with experience in developing and supporting commercial and non-commercial clinical trials.

The ICTR and BIOS jointly power the Trial Innovation Unit.

BIOS is led by Daniel Hanley, MD, who has unique expertise in the coordination and management of trials across all areas of human subject research.

After the initial 2 hours of free consultative service offered by the TIU, BIOS services are fee based and can include the following:

BIOS Services

Direction and Planning for Grant Preparation

Biostatistics Planning and Analysis

Protocol Development
Comprehensive Risk Assessment
sIRB (single IRB) Coordination and Reliance Agreements (SMART IRB)
Recruitment and Retention Plan Development
Cohort Discovery and Site Selection Assistance
Accelerated Project Start-Up
Standard Contracting Coordination
Database Design and Management
Budget Planning and Development
Clinical Project Management
DSMB Charter and Reporting Template Development
Clinical Site Monitoring
Brain Imaging Reading Center