Newsletter | August 8, 2024

08.08.24 -- The Future Of IRBs: Embracing Tech To Enhance Patient Safety, Research Efficiency

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OUTSOURCING MODELS

3 Essential Strategies To Elevate Your Clinical Research Skills

See, do, and listen. Simple right? Here, the authors advise clinical researchers on these three easy ways to improve their roles and professional relationships.

Are You An Emerging Biotech? Considerations When Selecting A CRO

Better understand how smaller biotech companies should approach CRO selection and what they should consider before launching their clinical development program.

Exploring The FDA's Draft Guidance On Psychedelic Drug Research

Join our panel of experts for an in-depth review of the FDA's guidance on psychedelic drug development, exploring necessary methodological adaptations for safety, pharmacology, and efficacy.

PPD™ FSP Solutions, Clinical Operations

With a proven track record built on decades of experience, we provide the talent and expertise to help our clients meet their timelines with much-needed resource flexibility, reliability, and continuity.

How To Improve Site Experience Through IRT And eCOA Integration

Experience automated patient information flow from IRT to eCOA, reducing errors and investigator burden. Kayentis Clin’form stands ready for integration, simplifying your trial processes.

REGULATORY & COMPLIANCE

The Future Of IRBs: Embracing Tech To Enhance Patient Safety, Research Efficiency

Univo IRB CEO Julie Blasingim explores the new era of IRBs and how they can leverage technology to stay on pace with and meet the needs of the rest of the clinical research industry.

Strategies For Post-Approval Lifecycle Management And Local PV

If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.

Diversity: Identifying Challenges, Opportunities, And Best Practices

By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and more.

Key Changes For Computerized Systems And Electronic Data

Explore several modifications introduced in the updated guidelines by the European Medicines Agency regarding computerized systems and electronic data in clinical trials.

EMA Services: Ensure Regulatory Success

Get support for post-authorization regulatory requirements, spanning product launches, management of variations, new indications, line extensions, and ensuring ongoing compliance.

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