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Premier Perspectives

The blog for insider insights in clinical development

Clinical Research: Phase 1 - Phase 4

Statistical Considerations for FDA COVID-19 Guidance

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March 27, 2020

Featured Posts

Learn more about the latest events and updates.

COVID-19

What Is FDA’s Emergency Use Authorization (EUA) and How Can It Help Develop Therapies Faster?

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March 20, 2020

COVID-19

Global Health Authorities Push for Rapid Development of COVID-19 Tests, Drugs and Vaccines

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March 20, 2020

Premier Voices Podcast

Conversations with Premier's subject matter experts
Premier Voices #1: Rare Oncology w/ Colin Hayward & Peter Larson

Premier Voices #1

Rare Oncology w/ Colin Hayward & Peter Larson
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Premier Voices #2: Registry Studies & Natural Histories in Rare Disease Trials w/ Angi Robinson & Juliet Moritz

Premier Voices #2

Registry Studies & Natural Histories in Rare Disease Trials w/ Angi Robinson & Juliet Moritz
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Premier Voices #3: The Placebo Problem Part 1 With Scott Millard

Premier Voices #3

The Placebo Problem Part 1 With Scott Millard
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Premier Voices #4: The Placebo Problem Part 2 With Michael Kuss

Premier Voices #4

The Placebo Problem Part 2 With Michael Kuss
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Premier Voices #5: Operationalizing the New MDR With Janet Kube (Part 1)

Premier Voices #5

Operationalizing the New MDR With Janet Kube (Part 1)
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Premier Voices #6: Operationalizing the New MDR With Janet Kube (Part 2)

Premier Voices #6

Operationalizing the New MDR With Janet Kube (Part 2)
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Premier Voices #7: Rare Disease Advocacy & International Ataxia Day w/ Alan Thomas (Ataxia & Me)

Premier Voices #7

Rare Disease Advocacy & International Ataxia Day w/ Alan Thomas (Ataxia & Me)
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Premier Voices #8: Engaging Patients in Clinical Trials w/ Alan Thomas & Juliet Moritz

Premier Voices #8

Engaging Patients in Clinical Trials w/ Alan Thomas & Juliet Moritz
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COVID-19 Update: What Sponsors Need to Know About the New FDA Guidance

COVID-19 Update

What Sponsors Need to Know About the New FDA Guidance
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Recent Posts

Learn more about the latest events and updates.

COVID-19

FDA Issues Guidance on Clinical Trials During COVID-19

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March 20, 2020

Consulting

UPDATE – Draft FDA Guidance Concerning Combination Products

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March 18, 2020

COVID-19

Considerations for Ensuring Trial Continuity in the Wake of COVID-19

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March 18, 2020

Consulting

INTERACT Meetings: Streamlining Early Clinical Development

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February 19, 2020

Consulting

Reimbursement Rules & Considerations for Medical Device Development in Asia

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January 8, 2020

Clinical Research: Phase 1 - Phase 4

Considerations for Operationalizing Pediatric Oncology Studies

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December 18, 2019