Characteristics of Favorite Clinical Sites

What makes some clinical sites easier to work with than others?

Characteristics of Favorite Clinical Sites​

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Characteristics of Favorite Clinical Sites​

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Characteristics of Favorite Clinical Sites

What makes some clinical sites easier to work with than others? Bright’s clinical research associates Liz Reedy and Erica Kerstetter discuss four characteristics their favorite sites have in common and how those characteristics contribute to a strong working relationship and a more efficient and enjoyable clinical study process.

Characteristics of Favorite Clinical Sites

What makes some clinical sites easier to work with than others? Bright’s clinical research associates Liz Reedy and Erica Kerstetter discuss four characteristics their favorite sites have in common and how those characteristics contribute to a strong working relationship and a more efficient and enjoyable clinical study process.

Characteristics of Favorite Clinical Sites

What makes some clinical sites easier to work with than others? Bright’s clinical research associates Liz Reedy and Erica Kerstetter discuss four characteristics their favorite sites have in common and how those characteristics contribute to a strong working relationship and a more efficient and enjoyable clinical study process.

Characteristics of Favorite Clinical Sites

What makes some clinical sites easier to work with than others? Bright’s clinical research associates Liz Reedy and Erica Kerstetter discuss four characteristics their favorite sites have in common and how those characteristics contribute to a strong working relationship and a more efficient and enjoyable clinical study process.

Characteristics of Favorite Clinical Sites

What makes some clinical sites easier to work with than others? Bright’s clinical research associates Liz Reedy and Erica Kerstetter discuss four characteristics their favorite sites have in common and how those characteristics contribute to a strong working relationship and a more efficient and enjoyable clinical study process.
Bright Research at LSI 2025

Bright Research at LSI 2025

Thank you LSI for this incredible event. Learn more…

Andrea Fenton Abbs: 2025 Women in Business honoree

Andrea Fenton Abbs: 2025 Women in Business honoree

Andrea Fenton Abbs has been recognized by Minneapolis/St. Paul…

Medical Alley (3/6/2025)

Medical Alley (3/6/2025)

Conversations and connections at our favorite Minneapolis venues like…

News
Bright Research

Medical Alley (3/6/2025)

Conversations and connections at our favorite Minneapolis venues like the Walker Art Center, remind us of the power of meaningful relationships and learning from each other in our MedTech community. Learn more about our experience at Medical Alley (3/6/2025) here.

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News
Bright Research

Scott Brown at CRT25

Attending CRT25? Connect with Scott Brown, Bright’s Chief Scientific Strategist. With his extensive experience in medical device clinical research strategy, statistical expertise, and consulting in FDA regulatory interactions, Scott’s insights are second to none.

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Success Stories
Dylan Lukes, PhD

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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SUCCESS STORY

New Literature Review Saved 3 Years and $2 Million

A medical device company’s post-approval study launch had been stalled for so long that continued FDA approval for their product was at risk. Furthermore, the company’s planned post-approval study, which aimed to monitor the long–term safety of their medical device, required a lengthy, five-year follow-up – and thus a large consumption of resources. Bright Research was brought in to help.

SUCCESS STORY

A Two-Study Strategy for an Emergent-Use Device

A medical device company developed a brilliant solution for a rare but life-threatening situation that could be encountered during standard percutaneous coronary interventions (PCIs). Due to the complexity of PCIs and the infrequent but very serious nature of the clinical situation where this device would be needed, gathering data on device safety and efficacy was going to be difficult. With the FDA requiring a robust, prospective clinical trial, the client needed to figure out a way to overcome this data-gathering challenge and get their device on the market. It was Bright’s time to shine.

SUCCESS STORY

Bright’s Novel Endpoint Proposal Creates Success for Med Device Start-Up

Opting for a rare clinical event endpoint meant that a medical device company’s proposed clinical trial would require thousands of subjects and a years-long enrollment period. Options were limited as all prior device studies in this therapeutic space had used this same rare endpoint, too.

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.

FEATURED INSIGHT

2024 Bright Research Year in Review

2024 was a productive and successful year for Bright Research. Here are 5 key efforts we took in 2024.

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.

FEATURED NEWS

Bright Research at LSI 2025

Thank you LSI for this incredible event. Learn more about Bright's experience at LSI 2025 here.

Our clients are

Medical device companies requiring clinical studies for their Class II and Class III products. Medical device companies requiring clinical studies for their Class II and Class III products.

Strategic leaders who begin with the end in mind & appreciate the critical role clinical studies play in the success of their business

Efficiency & quality experts who invest in doing it right the first time.

Ethical professionals who act with integrity, treating others with respect & kindness.

Andrea Fenton Abbs

CEO and Founder

Casey Johnson

Operations & Administrative Coordinator

Andrea Fenton Abbs

CEO and Founder

Jenny Lam

Clinical Research Associate

Research
Done Bright

Bright Research is a clinical research organization (CRO) specializing in medical devices. We manage clinical trials from concept to completion, with smarts and sophistication to make the complex look easy. We provide clinical research solutions with innovative strategies, superb execution, and personalized service.

We take pride in using our broad and deep experience and lessons learned to make your life easier and become a seamless extension of your team.