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Premier Perspectives

The blog for insider insights in clinical development

Consulting

Can Your Clinical Data Strategy Keep Pace?

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September 3, 2020

Featured Posts

Learn more about the latest events and updates.

Clinical Research: Phase 1 - Phase 4

Considerations for Applying Adaptive Design Approaches to Early Oncology Studies

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August 20, 2020

Clinical Research: Phase 1 - Phase 4

Minimizing Early-Stage Oncology Failures with Adaptive Design Approaches

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August 5, 2020

Premier Voices Podcast

Conversations with Premier's subject matter experts
PREMIER VOICES #14: Setting a Real-World Strategy in an Evolving Clinical Research Environment

PREMIER VOICES #14

Setting a Real-World Strategy in an Evolving Clinical Research Environment
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PREMIER VOICES #13: Early-Phase Oncology – Emerging From the Crisis & Innovating for the Future

PREMIER VOICES #13

Early-Phase Oncology – Emerging From the Crisis & Innovating for the Future
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PREMIER VOICES #12: Direct-to-Patient – Is This the ‘New Normal’ for Clinical Trials?

PREMIER VOICES #12

Direct-to-Patient – Is This the ‘New Normal’ for Clinical Trials?
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PREMIER VOICES #11: Statistical Considerations in the Wake of COVID-19

PREMIER VOICES #11

Statistical Considerations in the Wake of COVID-19
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PREMIER VOICES #10: COVID-19 Update – How the FDA's Emergency Use Authorization Can Help Develop Therapies Faster

PREMIER VOICES #10

COVID-19 Update – How the FDA's Emergency Use Authorization Can Help Develop Therapies Faster
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PREMIER VOICES #9: COVID-19 Update – What Sponsors Need to Know About the New FDA Guidance

PREMIER VOICES #9

COVID-19 Update – What Sponsors Need to Know About the New FDA Guidance
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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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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 #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 #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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Recent Posts

Learn more about the latest events and updates.

Medical and Regulatory Affairs

The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One

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July 31, 2020

Consulting

Creating a Compliant eCTD: Avoiding Common Regulatory and Technical Pitfalls on the Path to Submission

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July 22, 2020

Consulting

Long-Term Follow-Up in Gene Therapy Trials: Ensuring Patient Engagement & Regulatory Compliance

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July 17, 2020

COVID-19

Managing Pandemic-Related Protocol Deviations: Tips for Clinical Trial Conduct

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May 29, 2020

Data Management & Biostatistics

Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm?

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May 26, 2020

COVID-19

Data Driven: How Electronic Patient-Reported Outcomes (ePROs) Provide a Vital Opportunity to Capture Key Data Beyond the COVID-19 Crisis

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April 30, 2020

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