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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.

See It In Action
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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 & REGULATORY CONSULTING CLINICAL RESEARCH & DEVELOPMENT MEDICAL DEVICE & DIAGNOSTICS PREMIER ECOSYSTEM

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 & hematologydermatologyneurosciencepediatricsmedical deviceanalgesia

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

Patient Partnering in Clinical Development

Virtual Conference—Presentation: Decentralized Clinical Trials—Setting the Scene, followed by a Panel Discussion on DCTsSeptember 28, 2021
webinar

Webinar: 505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors

Presenters: Cathy Gatza, PhD, VP of Regulatory and Strategy, Camargo, and Andrea Miller, Manager of Life Science Solutions, CamargoSeptember 29, 2021
webinar

Webinar: Empowering Oncology Patients to Maximize Study Outcomes: Strategies and Considerations for Sponsors

Presenters: Ashley Herrick, Ph.D., Executive Director, Oncology Program Strategy, Premier Research, and Nicole Carswell, Executive Director, Patient Engagement & Recruitment, Premier ResearchOctober 27, 2021
latest resources
blog

A Primer on Cancer Immunotherapy Part 2: The Cancer Immune Response & Mechanisms of Resistance

By Ashley Herrick
August 12, 2021
blog

A Primer on Cancer Immunotherapy Part 1: Goals & Major Approaches

By Ashley Herrick
August 10, 2021
blog

Introduction to CAR T-Cell Therapy Part 2: Additional Considerations & Future Opportunities

By Ashley Herrick
July 15, 2021

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.

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

Dermatology

Premier Insight 270: A Rosacea Trial Failed Many Enrollment Hurdles.
A Rosacea Trial Failed Many Enrollment Hurdles.
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