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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

Outsourcing in Clinical Trials (OCT) Southern California

Booth 36
Conference Presentation on Dec. 7: Integration of genomics into cancer therapy: Effective patient selection tools and design considerations for optimal clinical trialsDecember 7, 2021 – December 8, 2021
event

Outsourcing in Clinical Trials (OCT) UK & Ireland

Booth 13December 8, 2021 – December 9, 2021
event

ASH 2021

Booth 3811December 11, 2021 – December 14, 2021
latest resources
blog

Study Start-Up: Why You Really Need to Get This Right

By Andrea Ochoa
November 19, 2021
blog

Using the 505(b)(2) Pathway to Streamline Regulatory Approval for Combination Products

By Ann Leonard
October 26, 2021
white paper

Phase 1 Trials: Strategies for Site Selection and Dose-Escalation

By Abie Ekangaki and Ashley Herrick and Meghan Shea and Federica Vinciati
September 30, 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.

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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