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BiotechSM

Delivering outcome‑focused insights that support your efforts in developing life‑changing therapies.

LATEST INSIGHTS
IN CLINICAL DEVELOPMENT
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Strategic Product Development

Offering decades of strategic development experience, global compliance, and therapeutic expertise to ensure your promising therapy isn’t delayed by risk or limited resources.

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PremierOne Ecosystem

Combining highly trained specialists and carefully refined processes with our world-class technology.

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Global Regulatory Consulting

Industry leaders with comprehensive submission experience to strategically position your product.

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Core Capabilities

Offering a strategic combination of industry acumen, global compliance, and therapeutic expertise to help ensure that your innovative ideas aren’t hindered by limited resources.

PRODUCT DEVELOPMENT CONSULTING CLINICAL RESEARCH & DEVELOPMENT Real-World & Late Phase PREMIER ECOSYSTEM Functional Service Provider

Our Expertise

We’re clinical development experts focused on helping today’s most innovative biotech and specialty pharma companies take their best ideas from benchtop to bedside.

therapeutic & special population expertise

rare diseasecell & gene therapyoncology & hematologydermatologymedtechneurosciencepediatricsanalgesiawomen’s health

Leading the way

Our customers are highly innovative biopharmaceutical companies doing incredible things. It’s amazing and often very complex science, and we’ve positioned ourselves right in the middle of the action, supporting therapeutic areas where pioneers are doing the most exciting work.
events & webinars
event

Outsourcing in Clinical Trials (OCT) Southern California 2022

Booth #4September 28, 2022 – September 29, 2022
webinar

The Expanding Role of RWE in Rare Studies

September 29, 2022
event

Women’s Health Innovation Summit

Booth #14September 29, 2022 – September 30, 2022
latest resources
blog

A Fit-for-Purpose Path Forward: Linking RWD to Your Overall Data Strategy

By Nach Davé
September 26, 2022
blog

What is Real-World Data and Evidence and How It Can Facilitate Clinical Development

By Nach Davé
September 19, 2022
blog

How to Select Drugs to Switch from Rx to OTC

By Colleen Coleman
September 12, 2022

Premier Insights

Customized services for each program, with tailored processes designed to meet highly specific needs. We’ve learned a lot about what works and what doesn’t. Browse the latest learnings and insights from our clinical development professionals.

Oncology & Hematology

Premier Insight 275: Streamlining Regulatory Submissions for a Novel Advanced Therapy Medicinal Product Trial
Streamlining Regulatory Submissions for a Novel Advanced Therapy Medicinal Product Trial

Cell & Gene Therapy

Premier Insight 274: Site Selection, Manufacturing, and Long-Term Follow-Up in a Transition Phase 1/2 Gene Therapy Trial
Site Selection, Manufacturing, and Long-Term Follow-Up in a Transition Phase 1/2 Gene Therapy Trial

Neuroscience

Premier Insight 273: Conclusive & Positive Results Delivered Ahead of Time – By Eight Months
Conclusive & Positive Results Delivered Ahead of Time – By Eight Months

Pediatrics

Premier Insight 272: Delivering the Global Expertise Required to Coordinate a Pediatric Gene Therapy Trial
Delivering the Global Expertise Required to Coordinate a Pediatric Gene Therapy Trial
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