CREATIVE
CAPABLE
ADAPTABLE
BRIGHT Research Partners is a Clinical Research Organization (CRO) focused on designing and managing medical device clinical 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.
Our Company
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 medical device 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
- Monitoring (On-Site and Remote)
- Study Management
- Study Close-Out
- Global Market Authorization, Registration, and Licensure
- Labeling, Marketing Claims, Promotional and Advertising Materials
- Ongoing Regulatory Support
Data Management
- Database Build
- Data Cleaning
- Reporting
- Electronic Trial Master File Management
- Technical and Medical Writing
Other Services
- 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
Our Difference
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.
Our Team
Andrea Fenton Abbs
Chief Executive Officer, Founder
Andrea founded BRIGHT Research Partners to provide companies with a refreshing alternative for their clinical research needs…
Tom Goudreault, MBA
Chief Operating Officer
Tom has over 30 years of management experience in healthcare, higher education and consumer packaged goods and leads the…
Scott Brown, PhD
Chief Scientific Strategist
Scott has 18 years of experience in biostatistics for clinical trials, covering a wide variety of therapeutic areas including…
Joan Grebin Hazen, BA, MBA
Director of Clinical Research
Joan brings over 30 years of clinical research experience and a passion for quality to BRIGHT. She has worked for a variety of organizations…
Michele Herzog, RN, MA, CCRA, CMC
Manager – Monitoring
Michele is a licensed registered nurse with over 20 years of clinical research experience. She has spent the majority of her research…
Jeremy Abbs, MBA
Business Development Strategist
Jeremy has been an enthusiastic advocate of BRIGHT for years, both as Andrea’s husband and medical device professional…
Lisa Gallatin, RAC
Director of Regulatory & Quality
Lisa uses her 17 years of regulatory experience to assist BRIGHT clients in the development and execution of thoughtful, creative…
Robin Solinsky, CCRP
Director of Data Management
Robin has worked on all aspects of clinical trials, from beginning to end, across a multitude of companies that range from small start-ups to industry giants…
Jean Gettis, MS, CCRA
Monitor
With over 20 years of clinical research experience, Jean began her career as a study coordinator with Radiant Research…
Kim Hartz, MS
Monitor
Kim enjoys all aspects of research collaboration including relationship development, trial planning/strategy and the full execution of clinical studies…
Mary Ovick
Manager – Clinical Operations
Mary is an operations and project management professional with over 9 years of clinical research experience. Mary is highly proficient…
Marit Slawson
Director of Project Planning & Analysis
Marit has a strong background in project management and quality assurance, including various senior engineering roles and…
Melissa Ingram, PhD
Study Director
Melissa has more than 15 years of research experience, in both academia and industry, and is interested in translating science into products…
Hannah Bearinger, PhD
Associate Study Director
Hannah has experience in biomaterials research, medical device product development, and working with start-up companies…
Danielle Kerr, MS
Associate Study Director
Dani has study director and monitoring experience in cardiovascular and peripheral vascular studies, and she’s eager to apply her 7+ years…
Kathryn Evans Cizio, CCRP
Project Manager
Kathryn brings 10 years of clinical and project management experience. She earned a Bachelor of Arts degree in health promotion and…
Brian Harvey
Principal Data Specialist
Brian brings an enthusiasm for data management and nearly 20 years of clinical research experience to BRIGHT. He previously worked at the University of Minnesota…
Noelle Hadley, MS
Biostatistician
Noelle earned her Master’s degree in biostatistics from Tulane University and began her career in medical research…
Kelly Kwong
Clinical Research Coordinator
Kelly is a graduate from the University of Minnesota, where she obtained a Bachelor of Science degree in genetics, cell biology…
Santiago Charry
Clinical Data Coordinator
Santiago is a graduate from the University of Minnesota with a Bachelor of Science in biology as well as a minor in environmental…
Rebecca Koller
Clinical Research Associate
Becca brings her passion for science and her experience in clinical operations to the BRIGHT team…
Anisa Ahmed
Clinical Research Coordinator
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…
Emily Zabeli, RN
Clinical Research Coordinator
Emily’s passion and curiosity for innovation and care excellence have driven her to the field of clinical research after working more than 10 years as a registered nurse…
Barb Danson
Quality Systems & Technical Writing Advisor
Barb has 30+ years of medical device experience working in clinical, quality, and regulatory roles at ATS Medical, Vascular Solutions…
Todd Grantham
Data Management Programmer
Todd is an experienced technology and training professional with over 11 years of combined experience in clinical research database and reporting tool development; electronic trial master file (eTMF) and electronic…
Malori Niver
Business Operations Manager
Malori brings 6 years of business administration experience to BRIGHT, where she gets to wear her favorite hats that include accounting, marketing…
Our Job Openings
At BRIGHT Research Partners, we are passionate about maintaining a human-first approach with our clients and team members because we believe that’s good for our business and all parties involved.
Are you looking for a job where you can bring your best self to work, collaborate with an inspired team, and achieve a level of excellence that makes you feel both proud and fulfilled? Are you a personable and adaptable professional who is looking for a clinical research career opportunity with a BRIGHT future?
Please send your résumé along with a cover letter to introduce yourself and tell us how you fit with our culture and how you could support our mission to provide human-first, best in class clinical research services.
jobs@brightresearchpartners.com
Join Our Team
BRIGHT is always seeking talented professionals who fit our culture and mission. Please contact us to discuss opportunities..
Contact Us
We look forward to hearing about how BRIGHT can assist you with your next project. From consultation to completion, we are here to help.
612-345-4544
730 Second Avenue South, Suite 500
Minneapolis, Minnesota 55402
Bright Research Partners
Minneapolis, Minnesota 55402