Newsletter | April 17, 2025

04.17.25 -- What Happens If The National Cancer Institute Loses Funding?

REGULATORY & COMPLIANCE

What Happens If The National Cancer Institute Loses Funding?

The National Cancer Institute is operating under a continuing resolution that maintains funding at the FY 2024 level of $7.22 billion. But when adjusted for inflation, it effectively reduces the real value of research dollars. So what are the consequences?

Advancing Development Of New Oncology Therapies

Learn how the FDA's Project FrontRunner expedites cancer drug approval for early advanced metastatic cancer, emphasizing efficacy and safety in earlier clinical settings.

2024 Safety And Regulatory Compliance Trends And Predictions

The introduction of artificial intelligence and machine learning into pharmacovigilance, safety, and regulatory workflows stands to have a major impact on process efficiency and employee workloads.

Navigating Regulatory And Privacy Updates In Clinical Trials

Explore how the guide for eRegulatory adoption in Canada provides resources to help stakeholders navigate these changes and enhance participant engagement and retention in clinical trials.

8 Critical Questions To Ask Your IRB

This article outlines eight essential questions to ask a potential IRB partner to assess their ability to help you navigate complex regulatory requirements while avoiding delays.

Successfully Managing The Transition From Research To Development

When transitioning from research to development it's important to thoroughly understand FDA requirements and engage the FDA early on, and create an efficient integrated development plan.

OUTSOURCING MODELS

How AI Redefines The Functional Service Provider Opportunity In Medical Affairs

Medical affairs can no longer afford to operate within legacy structures. Enter AI-enabled functional service provider (FSP) models that offer operational relief.

Things Emerging Biotech's Should Consider 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.

Considerations When Outsourcing Your Packaging Operations

Learn how outsourcing this key aspect of bringing products to market can benefit your organization and overall supply chain optimization.

Executive Q&A With SGS' Hudson, NH Bioanalytical Services Facility

Explore how SGS's Hudson facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

SMART First Human Dose (FHD)

A CDMO with the right team of experts can aid drug development, regulatory compliance, and clinical trial supply, accelerating timelines to first human dose clinical trials and the path to market.

Your Partners In Drug Development And Safety

How can Ergomed use its oncology expertise, global reach, and access to patients with rare and ultra-rare diseases can help your organization achieve efficient, high-quality clinical trial execution?

Drug-Drug Interaction Clinical Trials

We specialize in DDI studies, including stand-alone and 'cocktail' designs, assessing multiple CYP enzymes or transporters in single studies, from simple crossovers to complex adaptive trials.

Your Global CRO Partner In Oncology And Hematology

Learn about an organization dedicated to providing personalized and adaptive trial solutions and managing complex oncology and hematology clinical trials.

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