BRIGHT Research Partners is a Clinical Research Organization (CRO) historically focused on designing and managing medical device clinical studies and is now being tapped for pharmaceutical and IVD studies. BRIGHT offers an upbeat, refreshing environment where creative collaboration and quality consultation thrive. Whether you are an early-stage start-up or a large, global organization, we are confident we can help you achieve your strategic goals through sound clinical and regulatory planning and execution.
By leveraging the broad experience of our seasoned team, BRIGHT understands and effectively manages the risks and challenges of clinical research as well as the evolving regulatory landscape in the medical industry.
Founded in 2008, BRIGHT has partnered with numerous clients to provide strategic and effective solutions to clinical and regulatory questions. We are particularly proud that the vast majority of our business relationships developed through referrals from existing business partners. This is a testament to the confidence our clients have in BRIGHT’s experienced and personable team.
Quality of life is at the core of our culture. We encourage flexibility and balance, empowering our employees to bring their best selves to work so they can excel in providing high quality services and deliverables to our clients. Our corporate headquarters provides an open, collaborative workspace located in the heart of Minneapolis.
Our Services and Experience
BRIGHT is an experienced Clinical Research Organization (CRO) with extensive knowledge of many therapeutic areas, including cardiovascular, neurology, orthopedics, and urology. The transferable skills, paired with the aptitude and desire to learn, ensure BRIGHT is poised to provide comprehensive clinical and regulatory support for projects involving new conditions, devices, and therapies.
Clinical and Regulatory Strategy
- Statistical Strategy and Analysis
- Study Design and Approval
- Study Site Establishment
- Study Start-up and Launch
- Regulatory Assessment
- Global Regulatory Strategy Development
Clinical and Regulatory Execution
- Study Execution
- Study Management
- Study Close-Out
- Global Market Authorization, Registration, and Licensure
- Labeling, Marketing Claims, Promotional and Advertising Materials
- Ongoing Regulatory Support
- Database Build
- Data Cleaning
- Electronic Trial Master File Management
- Technical and Medical Writing
- Auditing (IRB, Study) and Inspection Preparedness Activities (FDA and Notified Body)
- Board and Executive Presentations
- Venture Capital (VC) Investment Due Diligence
- Key Opinion Leader (KOL) Introductions and Networking
- Literature Reviews
- Grant Writing
- Medical Coding (MedDRA and WHO-DDE)
- Procedure Development (Sponsor, Core Lab, Study-Specific)
- Study Rescue
- ClinicalTrials.gov Management
- Quality System Development for Medical Devices
- Other Documentation, Registrations, and Administrative Support
View a full list of clinical and regulatory services here
We are best known for our personal and conscientious approach to managing projects. Your goals are of utmost importance, and we strive to meet them by using creative strategies and providing quality deliverables. Our highly adaptable team responds to change (both planned and unanticipated) with positivity and thoughtfulness.
BRIGHT manages relationships across all functional groups of a company as well as with the executive team, board of directors, and physicians. We collaborate with the best-in-class preclinical and database service providers, and we closely maintain those relationships to ensure successful trial and business outcomes.
Andrea founded BRIGHT Research Partners to provide companies with a refreshing alternative for their clinical research needs...
Tom has over 30 years of management experience in healthcare, higher education and consumer packaged goods and leads the...
Scott has 18 years of experience in biostatistics for clinical trials, covering a wide variety of therapeutic areas including...
Joan brings nearly 30 years of clinical research experience and a passion for quality to BRIGHT. She has worked for a variety of organizations...
Michele is a licensed registered nurse with over 20 years of clinical research experience. She has spent the majority of her research...
Jeremy has been an enthusiastic advocate of BRIGHT for years, both as Andrea’s husband and medical device professional...
Lisa brings over 15 years of regulatory experience to BRIGHT and assists clients in the development and execution of thoughtful...
Robin crossed over into clinical research after a few years as a quality engineer at Abbott (formerly St. Jude Medical)...
Kim enjoys all aspects of research collaboration including relationship development, trial planning/strategy and the full execution of clinical studies...
Mary is an operations and project management professional with over 9 years of clinical research experience. Mary is highly proficient…
Marit is a graduate of the University of Minnesota, where she obtained a Bachelor of Biomedical Engineering with a minor in Biology...
Hannah has experience in biomaterials research, medical device product development, and working with start-up companies...
Melissa has more than 15 years of research experience, in both academia and industry, and is interested in translating science into products...
Kathryn brings 10 years of clinical and project management experience. She earned a Bachelor of Arts degree in health promotion and...
Noelle earned her Master’s degree in biostatistics from Tulane University and began her career in medical research...
Kelly is a graduate from the University of Minnesota, where she obtained a Bachelor of Science degree in genetics, cell biology...
Santiago is a graduate from the University of Minnesota with a Bachelor of Science in biology as well as a minor in environmental...
Becca brings her passion for science and her experience in clinical operations to the BRIGHT team...
Anisa is a recent graduate from the University of Minnesota, where she received a Bachelor of Science degree in genetics, cell biology, and development with a minor in Spanish studies...
Katie first joined the BRIGHT team as an undergraduate intern, learning the skills necessary for executing successful clinical trials...
Barb has 30 years of medical device experience, having worked in quality and regulatory roles at companies including ATS Medical…
Lisa is a longtime cardiac care nurse with over 18 years of experience working as a clinical research professional, nurse clinician…
Todd is an experienced technology and training professional with over 8 years of experience in learning management systems, information technology, and developing ESL course curriculum...
Malori’s passion revolves around small businesses and participating in their elevation and growth. While her expertise is in real estate…
Working at BRIGHT spans beyond joining a collaborative and inspired team. We believe that our quality work stems from team members who find balance and fulfillment in their job. We emphasize the importance of our team’s work-life balance and strive to enable everyone to bring their best self to work.
If you are a personable and adaptable clinical research professional who excels in a team-driven environment, look no further.
Please inquire at firstname.lastname@example.org
Join Our Team
730 Second Avenue South, Suite 500
Minneapolis, Minnesota 55402
Bright Research Partners
Minneapolis, Minnesota 55402