Fast-track clinical trial procedures in the EU: turning complexity into opportunity

by Pivotal

Despite regulatory harmonization, launching a clinical trial in Europe can still be complex and time-consuming. However, evolving fast-track procedures are changing this landscape.

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Building Trust Through Quality-Driven Clinical Solutions

by Pivotal

As the clinical research industry continues to grow, companies are facing increasing pressure to meet strict regulatory requirements while keeping studies moving efficiently. Sponsors today need depen...

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Retention in Clinical Trials

by Pivotal

Clinical trials are the cornerstone of evidence-based medicine, yet a remarkable proportion of them fail not because the science is wrong, but because participants do not stay.

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Clinical Trials in an Intensive Care Unit: Challenges and Successful Implementation

by Pivotal

Clinical trials in the Intensive Care Units (ICUs) are among the most complex and demanding studies in clinical research. The scientific rationale for studying interventions in critically ill patients...

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Navigating EU-UK Dual-Track Clinical Trial Regulation in Parallel

by Pivotal

How sponsors can leverage both the EU Clinical Trials Regulation and UK’s reformed framework to achieve cost efficiencies, faster timelines, and stronger regulatory positioning.

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Successful Rescue and Accelerated Restart of a Clinical Trial for NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors

by Pivotal

A multi‑country oncology study regained momentum through structured transition planning, seamless cross‑functional collaboration and decisive operational oversight, regulatory recovery, and discip...

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AI in drug development. A CRO’s strategic roadmap

by Pivotal

The AI revolution in Pharmaceutical R&D is transitioning from experimental curiosity to operational necessity. This transformation is supported by quantifiable operational improvements: AI-enabled dis...

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Drug-Resistant Focal Epilepsy: Clinical Trials and Emerging Therapies. Transforming Patient Care Through Innovation

by Pivotal

Drug-resistant epilepsy (DRE) is one of the most significant challenges in modern neurology. Affecting approximately 15-16 million people worldwide—about 30% of all individuals with epilepsy¹—thi...

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Transforming Clinical Data into Actionable Insights

by Pivotal

Taking advantage of advancements in business intelligence, clinical research has transitioned from manual data processing to sophisticated AI-driven analytics, bridging the gap between clinical and bu...

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Alzheimer’s Disease Clinical Trials and Emerging Therapies: Transforming Patient Care Through Innovation

by Pivotal

Alzheimer’s disease (AD) is one of the most significant and pressing challenges in modern healthcare. Affecting more than 50 million people worldwide1, AD places an immense and growing social and ec...

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Case Study: Accelerating Protocol Development for a European Biotech’s Bi-Specific Antibody Program

by Pivotal

El equipo médico oncológico de Pivotal, con amplia experiencia en estudios de fase inicial y redacción médica, asumió el reto de acelerar el desarrollo del protocolo y garantizar un inicio regula...

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Elevating Clinical Development with Specialized Medical Services

by Pivotal

In the complex world of pharmaceutical and biotechnology drug development, PIVOTAL serves as your trusted medical partner – delivering expert medical oversight and strategic insight across every pha...

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