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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 MEDICAL DEVICE Diagnostics 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 & hematologydermatologyneurosciencepediatricsanalgesiawomen’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

World Orphan Drug Congress USA 2022

Booth #412July 11, 2022 – July 13, 2022
webinar

Addressing Challenges In Bringing Male Contraceptives to Market

July 21, 2022
webinar

The Expanding Role of RWE in Rare Studies

August 4, 2022
latest resources
blog

Full Service or FSP? How to Choose the Right Model for Your Study

By Cheryl Silva
June 28, 2022
blog

7 Tips for Designing and Operationalizing Rare Disease Natural History Studies

By Kris O’Brien
June 27, 2022
blog

How to Use Patient Registries and Natural History Studies in Rare Disease Development

By Kris O’Brien
June 17, 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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