CREATIVE

CAPABLE

ADAPTABLE

BRIGHT Research Partners is a Clinical Research Organization (CRO) primarily focused on 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 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
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
  • Medical Coding (MedDRA and WHO-DDE) 
  • Procedure Development (Sponsor, Core Lab, Study-Specific)
  • Study Rescue
  • Clinical Evaluation Reports (CERs)
  • 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

Andrea Fenton Abbs

Founder, Managing Partner Andrea founded BRIGHT Research Partners to provide companies with a refreshing alternative for their clinical research needs...
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Tom Goudreault, MBA

Tom Goudreault, MBA

General Manager Tom brings over 30 years of management experience in healthcare, higher education and consumer packaged goods and leads the...
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Jeremy Abbs, MBA

Jeremy Abbs, MBA

Business Development Jeremy has been an enthusiastic advocate of BRIGHT for years, both as Andrea’s husband and medical device professional...
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Joan Grebin Hazen, BA, MBA

Joan Grebin Hazen, BA, MBA

Clinical Research Consultant Joan brings nearly 30 years of clinical research experience and a passion for quality. She has worked for a variety of organizations...
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Michele Herzog, RN, MA, CCRA, CMC

Michele Herzog, RN, MA, CCRA, CMC

Clinical Research Consultant Michele is a licensed registered nurse with over 20 years of clinical research experience. She has spent the majority of her research...
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Scott Brown, PhD

Scott Brown, PhD

Biostatistician Scott brings 18 years of experience in biostatistics for clinical trials, covering a wide variety of therapeutic areas including...
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Lisa Gallatin, RAC

Lisa Gallatin, RAC

Regulatory Consultant Lisa brings over 15 years of regulatory experience to BRIGHT and assists clients in the development and execution of thoughtful...
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Robin Solinsky, CCRP

Robin Solinsky, CCRP

Clinical Research Consultant Robin crossed over into clinical research after a few years as a quality engineer at Abbott (formerly St. Jude Medical)...
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Mindy Ditch, MS

Mindy Ditch, MS

Clinical Research Consultant Mindy brings over 16 years of experience in designing, executing, and managing clinical trials. She has conducted research...
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Christine Eickhoff, MS, MPH

Christine Eickhoff, MS, MPH

Clinical Research Consultant Christine brings more than 25 years of clinical research experience in both the medical device and pharmaceutical industries...
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Kim Hartz, MS

Kim Hartz, MS

Clinical Research Consultant Kim enjoys all aspects of research collaboration including relationship development, trial planning/strategy and the full execution of clinical studies...
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Mary Ovick

Mary Ovick

Clinical Research Consultant Mary is an operations and project management professional with over 9 years of clinical research experience. Mary is highly proficient…
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Marit Slawson

Marit Slawson

Consultant Marit is a graduate of the University of Minnesota, where she obtained a Bachelor of Biomedical Engineering with a minor in Biology...
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Hannah Bearinger, PhD

Hannah Bearinger, PhD

Clinical Research Consultant Hannah has experience in biomaterials research, medical device product development, and working with start-up companies...
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Kelly Kwong

Kelly Kwong

Clinical Research Consultant Kelly is a graduate from the University of Minnesota, where she obtained a Bachelor of Science degree in genetics, cell biology...
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Santiago Charry

Santiago Charry

Clinical Research Consultant Santiago is a graduate from the University of Minnesota with a Bachelor of Science in biology as well as a minor in environmental...
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Rebecca Koller

Rebecca Koller

Clinical Research Consultant Becca brings her passion for science and her experience in clinical operations to the BRIGHT team...
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Anisa Ahmed

Anisa Ahmed

Clinical Research Consultant 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...
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Katie Burns

Katie Burns

Clinical Research Consultant Katie first joined the BRIGHT team as an undergraduate intern, learning the skills necessary for executing successful clinical trials...
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Barb Danson

Barb Danson

Clinical Research Consultant Barb brings 30 years of medical device experience, having worked in quality and regulatory roles at companies including ATS Medical…
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Lisa Mayberry, RN, MSN, CCRA

Lisa Mayberry, RN, MSN, CCRA

Clinical Research Consultant Lisa is a longtime cardiac care nurse with over 18 years of experience working as a clinical research professional, nurse clinician…
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Todd Grantham

Todd Grantham

Consultant 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.
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Malori Niver

Malori Niver

Business Operations Malori’s passion revolves around small businesses and participating in their elevation and growth. While her expertise is in real estate…
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Our Job Openings

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 info@brightresearchpartners.com

Biostatistician
Position

The biostatistician role will support multiple clinical research projects in a statistical and data management capacity with direction from a senior biostatistician. This role will work closely with senior and junior BRIGHT clinical research professionals and medical device manufacturers (clients). This is a great opportunity for a biostatistician with 2-3 years of industry or CRO experience. This role will gain exposure to multiple therapeutic areas, while working with a fun and collaborative team.

Responsibilities

NOTE: The scope of responsibilities is dependent on the client’s agreement with BRIGHT Research Partners and may include, but are not limited to, the following:

  • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trial data using SAS
  • Prepare statistical sections of clinical study reports and data management reports and listings
  • Develop table and listing shells based on statistical analysis plans or publication/presentation needs
  • Perform quality control and validation for SAS programs and other study documents (e.g., presentations and reports)
  • Provide statistical analysis and reports to Data Safety Monitoring Boards and Clinical Events Committees
  • Review output across programs to ensure consistency
  • Review data management reports for outliers and other data issues
  • Generate randomization schedules
  • Provide input into development of case report forms (CRFs)
  • Interact directly with clients

Required Qualification & Abilities

  • 2-3 years’ experience in a statistician role using SAS
  • MS or equivalent degree in statistics; ideal candidate would have some relevant academic or industry clinical research experience
  • Proficiency with SAS for statistical analysis and reporting; ideal candidate would have practical experience using SAS to analyze and report clinical data
  • Willingness to learn industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Excellent organizational skills, time management skills, and ability to coordinate workload and meet established deadlines
  • Excellent communication and interpersonal skills
Join Our Team
BRIGHT is always seeking talented professionals who fit our culture. 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

 info@brightresearchpartners.com

 BRIGHT Research Partners LinkedIn Profile

BRIGHT Research Partners

730 Second Avenue South, Suite 500

Minneapolis, Minnesota 55402

13 + 9 =

Bright Research Partners

730 Second Avenue South, Suite 500
Minneapolis, Minnesota 55402