About Us
Experience
Launched in 2015 with a focus on conducting strategic clinical trials with high accuracy and streamlined efficiency. Broad Street helps medical technology pioneers achieve success by accruing relevant clinical data for both regulatory approval and product improvement. Clients include companies ranging from start-ups to Fortune 500 corporations. Based centrally in the Minneapolis-St Paul, Minnesota area, Broad Street works with clients from coast to coast and in Europe; remote collaborations are as seamless as face-to-face. Therapeutic areas span cardiology, neurology, urology, oncology, pulmonology, infectious disease, obesity, and others. Technologies include imaging modalities, implants, therapeutic catheters, hemostatic agents, and more.
Approach
Every breakthrough biotechnology is unique and poised to improve patient outcomes; the clinical studies evaluating the technology should be customized to highlight its capabilities while also serving the company's business needs. Broad Street understands the priorities for clinical research from First in Human Pilot Studies to Pivotal Regulatory Trials to Post-Market Surveillance. Designing and conducting strategic and efficient clinical trials results in a quick path to regulatory approval and a successful entry into the competitive global marketplace. Broad Street helps plan and conduct every aspect of clinical research from protocol design to final results report and publication.
Why Us?
Broad Street can assist in planning and launching a new study or stepping in to manage an ongoing and evolving study. We leverage best practices in clinical research while adhering to all applicable regulations, to customize a plan for your innovative technology. Services include these and more.
- Study management
- Protocol development
- Site identification and qualification based on quantitative metrics
- Planning, conducting, and documenting all site visits and correspondence
- Study documentation and materials development
- Electronic Data Capture database and user interface design
- Launching and driving patient enrollment
- Case proctoring for complex procedures
- Monitoring sites for data accuracy
- Analyzing study metrics using innovative data science for continuous quality improvement
- Escalating issues crucial for sponsor oversight
- Data Safety Monitoring Board, Clinical Events Committee, and Core Laboratory coordination
- Trial Master File structure and maintenance
- Audit preparation
- Annual, final, and sub-study reports