Newsletter | March 19, 2026

03.19.26 -- The Cost Of Transactional Thinking In Clinical Research

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The Pulse: Global R&D Insights in Pharmaceuticals

Uncertainty is shaping every major decision in drug development. Discover what 150 global biotech and pharma leaders say about navigating cost, complexity, regulation, artificial intelligence, and partnerships in 2026. Explore shifting research and development priorities in an uncertain market, the growing impact of artificial intelligence on development performance, the strategies gaining traction, and how organizations are managing the balance between speed, cost, and complexity.

OUTSOURCING MODELS

The Cost Of Transactional Thinking In Clinical Research

Denise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.

Why Early CRO Choice Is Critical To Accelerating Delivery

Regulatory readiness for global expansion begins in Phase I. A development partner should design your trial and data collection to anticipate downstream regulatory requirements in your target regions.

Open-Label Study Assessing Relative And Absolute Bioavailability

Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.

Navigating The Enrollment Bottleneck In Early Oncology Trials

Slow oncology trial enrollment raises costs and delays progress. AI prescreening, patient-focused engagement, and early pharmacology studies help accelerate recruitment and optimize trial design.

Built Like A Tech Company: Why CROs Need A New Operating System

See why building digital, automated infrastructure is essential, and better aligns CROs with today's speed, compliance, and innovation needs.

Working With A Specialty Oncology CRO Versus A Large Generalist CRO

Specialty oncology CROs bridge the gap between traditional CRO operating models and the specialized needs of oncology sponsors by embedding deep oncology expertise across every function.

The Rise Of Targeted Modalities In Pharmaceutical Development

Targeted modalities are pushing the boundaries of technology, and their potential to transform patient care depends on leveraging the right expertise, technologies, and partnerships.

Supporting CRO/Research Services For Your Clinical Trials

From site selection to data management and regulatory guidance, Altasciences' experts orchestrate every aspect of your clinical programs. Expect quality, speed, and seamless collaboration at every step.

SPONSOR

The Phase 2 Endpoint Dilemma: Bridging Subjective Scales and Objective Measures in Neurodegenerative Trials.

This webinar discusses challenges in Phase 2 neurodegenerative trials, where slow disease progression and insensitive traditional scales like ADAS-Cog and MDS-UPDRS can miss meaningful treatment effects. The session also presents frameworks for integrating cognitive, functional, and biomarker measures and shows how real-world evidence can guide endpoint selection and improve go/no-go decisions for emerging therapies. Click here for more.

REGULATORY & COMPLIANCE

The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development

Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

Policy By Press Release Is Now A Real Problem

Sophia McLeod, an advocacy advisor at ACRO, explains ACRO's concerns about FDA staffing losses. She also talks about the effects of "policy by press release" rather than traditional notice-and-comment periods.

Ensuring Compliance In Gene Therapy Trials: IRB And IBC Views

Navigate ethical and regulatory challenges in neurological gene therapy trials, with expert insights on IRB/IBC collaboration, consent protocols, and oversight for vulnerable populations.

Is Your Clinical Trial Portfolio CTIS Compliant?

The Clinical Trials Regulation and its centralized digital platform, the Clinical Trials Information System (CTIS), are now mandatory. Are you prepared to navigate your next clinical trial in the EU?

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.

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