Newsletter | October 7, 2026

10.07.26 -- Investigator Responsibilities In Decentralized Clinical Trials

SPONSOR

Webinar: Closing the Gap Between Biomarker Data and Clinical Proof-of-Mechanism in Neurodegenerative Disease

How can sponsors determine whether a therapy reaches the CNS, engages its target and produces meaningful biological effects? In this webinar, experts from CHDR and Ardena will share insights from a 15-year partnership, using GCase and lipid biomarker case studies to explore integrated clinical and bioanalytical strategies that support target engagement, proof-of-mechanism and early development decisions. Click here to learn more.

DECENTRALIZED TRIALS

What The FDA Says About Investigator Responsibilities In DCTs

Learn exactly what the FDA says about the use of healthcare providers (HCPs), telemedicine, licensing, and practice standard requirements when executing a DCT.

Setting Up A Semi-Permanent Eye Exam Space

Inconsistent ocular data and slow visits often trace back to the exam room. Before finalizing site plans, learn what equipment, layout, and staffing a properly built space requires.

SPONSOR

Webinar: Operationalizing Adaptive Design for FDA's One-Trial Era

The FDA’s 2026 One-Trial pathway is changing how sponsors approach pivotal trial design. In this webinar, Veristat’s adaptive design experts explore the statistical frameworks, regulatory strategies, and practical considerations for building a defensible single pivotal trial. Hear a real-world case study demonstrating how adaptive design can reduce development timelines and costs while maintaining trial quality, offering insights for today’s clinical development teams. Click here to learn more.

TRIAL MANAGEMENT

To Prevent Parkinson's Disease, We Need New Biomarkers

Parkinson's disease research has shifted toward prevention and prodromal intervention but success with disease-modifying and preventive therapies depends on validated PD-specific biomarkers.

Obesity Clinical Trials: A Promising Research Landscape

Obesity is a hot topic in the pharmaceutical industry, with GLP-1 drugs dominating the headlines. Globally, there are 5,189 obesity trials, of which 1,119 are planned or ongoing.

IRB In Action: A Live Mock Board Review

Experience a live mock IRB review! Watch industry experts evaluate a fictional protocol to uncover insights into board decision-making, master the review process, and improve your future submissions.

Operationalizing Immuno-Oncology Studies

Managing CRS and immune risks demands early detection, rapid response, and skilled teams. Strong infrastructure and clear protocols enable safer immunotherapy trials beyond academic centers.

Combination Therapy Dose Optimization In Oncology Trials

Optimize dose selection in oncology trials by moving beyond toxicity limits. Use advanced modeling and benefit-risk analysis to improve efficacy and meet modern regulatory standards.

De-Risking The Neurology IND: Lessons From Early FDA Engagement

Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.

Supply Without Drag: Why Modern Supply Execution Needs a Different Kind of RTSM

Gain visibility, flexible supply management, and real-time decision support to reduce waste, control costs, and align supply with evolving trial needs.

Protocol-Driven, Customized Site Solution Strategy

As protocols become more complex and sites face new pressures, your site selection strategy needs to be more nuanced than ever before.

Accelerating Clinical Supply Through Integrated Drug Development

See how parallel processing integrates clinical supply into drug development, enabling simultaneous workstreams that address packaging, labeling, and sourcing challenges.

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