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A boutique clinical operations and strategic services organization supporting pharmaceutical, biotech, and medical device companies across all phases of clinical development.

Leadership Team
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Company Overview

BIA Clinical Group is a boutique clinical operations and strategic services organization supporting pharmaceutical, biotech, and medical device companies across all phases of clinical development since 2018.

Led by three Founders with more than 90 years of combined industry experience, BIA delivers senior-level teams through a highly collaborative, sponsor-focused model.

Unlike traditional CROs, BIA integrates directly with sponsor teams, functioning as a strategic extension of your organization while maintaining flexibility, responsiveness, and hands-on execution throughout the clinical lifecycle.

Learn More About Our Approach

We Specialize In

clinical operations and execution
monitoring and oversight
data review and study rescue
biostatistics, statistical programming and data management
translational medicine and clinical strategy
inspection readiness and data quality
Our Engagement Approach

How We Work

We embed seamlessly with your team to deliver expertise, accelerate execution, and drive meaningful results.

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Embedded Partnership Model

BIA does not operate like a CRO. We integrate directly with sponsor teams as an extension of your organization, aligning closely with priorities, timelines, and operational goals.

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Senior-Level Execution

Engagements are led by experienced clinical professionals, ensuring depth of expertise at every stage of execution.

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Flexible Engagement Model

Support scales across full programs, individual workstreams, or targeted operational needs depending on sponsor requirements.

Leadership Team

Carrie Guss, MSBA, RDN

Carrie Guss, MSBA, RDN

Founder & Managing Director
Clinical Operations

Theresa Stern, PhD

Theresa Stern, PhD

Founder & Managing Director Biostatistics

Rebecca Bakker-Arkema, RPh, MS, FAHA

Rebecca Bakker-Arkema, RPh, MS, FAHA

Founder & Managing Director Translational Medicine

Therapeutic Experience

Oncology
Rare Disease
Nephrology
Obesity
NASH
Diabetes
Cardiovascular
Cell Therapy
Infectious Disease
Women’s Health
Pediatrics
Dermatology
CNS

Let’s strengthen your clinical program.

Partner with an experienced clinical operations team focused on proactive oversight, operational execution, and data quality.