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Best of Bright Blog

Watch this space! The Bright Blog features our latest industry insights, team happenings, news, and the success stories where we helped our clients shine.

FEATURED INSIGHT

2025 Year in Review

As we close out 2025, we’re feeling proud of our accomplishments and energized by the opportunities ahead.
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FEATURED SUCCESS STORY

Beyond Statistics: Using the Totality of the Evidence to Gain Medical Device Approval

Using the totality of the evidence is key for gaining medical device approval. To successfully execute a strategy that tells the whole clinical story, given the available data, Bright leveraged the expertise of — and relationships built between — Bright, the client, the study's national PI, and the FDA. In the end, this approach contributed to the ultimate success: PMA approval.
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Molly Mjolsness, the new Director of Client Experience at Bright Research.

FEATURED NEWS

Welcome Molly Mjolsness: Director of Client Experience

We are thrilled to welcome Molly Mjolsness, MBA, PMP, as our new Director of Client Experience. Molly's expertise in clinical trials, project management, and customer experience will be a tremendous asset to our clients.
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Bright Blog

The Pitfall of “Too Much Data”
Insights

The Pitfall of “Too Much Data”

Andrea Abbs

Discover the pitfalls of—and tips for avoiding—this common problem.

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Five Key Qualities of Clinical Study Primary Endpoints
Insights

Five Key Qualities of Clinical Study Primary Endpoints

Scott Brown, PhD

Every medical device clinical study has endpoints, although they may be called something else, such as…

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Developing Strong Relationships in Clinical Research
Insights

Developing Strong Relationships in Clinical Research

Michele Herzog, RN, MA, CCRA, CMC

As I prepare to retire from my long and rewarding career in clinical research, I’ve reflected on key learnings to share with my amazing BRIGHT…

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Clinical Study Design – Begin with the End in Mind
Insights

Clinical Study Design – Begin with the End in Mind

Scott Brown, PhD

Avoid costly surprises during the study or regulatory application process.

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5 Tips for Sustaining a Company Wellness Program
Insights

5 Tips for Sustaining a Company Wellness Program

Malori Niver

Work-life balance. Mindfulness. Self-care. Is there a fly in here, or just the sound of buzzwords?…

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Regulatory Pathway Defines the Need for a Clinical Study
Insights

Regulatory Pathway Defines the Need for a Clinical Study

Lisa Gallatin, RAC, Director of Regulatory and Quality

You are developing a medical device that addresses a clinical need, but how do you get…

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5 Tips to Execute a Successful FDA Pre-Sub Meeting for Your Clinical Study
Insights

5 Tips to Execute a Successful FDA Pre-Sub Meeting for Your Clinical Study

Lisa Gallatin, RAC, Director of Regulatory and Quality

The pre-sub meeting process can be a powerful tool.

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5 Tips to Prep for a Successful FDA Pre-Sub Meeting
Insights

5 Tips to Prep for a Successful FDA Pre-Sub Meeting

Lisa Gallatin, RAC, Director of Regulatory and Quality

Make your pre-submission a success.

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Bright Insights
Insights

Bright Insights

Andrea Abbs

Welcome to our new blog! I founded Bright Research in 2008 with the dream of creating…

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