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FEATURED ARTICLES
Navigating The New EU Pharmaceutical Legislation: Key Implications For Pediatric Drug Development
UCB’s Senior Development Strategy Lead Pediatrics Martine Dehlinger-Kremer, Ph.D., discusses updates to the new EU Pharma legislation and how they impact pediatric drug development, including earlier pediatric investigational plans .
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![AMRC series 3]( "Why The Governed Hybrid Site Model Is Strategically Superior — Part 3")
Why The Governed Hybrid Site Model Is Strategically Superior — Part 3In the third and final part of this series, Paradigm Clinical Research CEO Kurt Mussina, who's become an advocate for the governed hybrid platform, explains why he believes it's the best fit for sponsors.
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![IND clock]( "Beyond The IND Clock: What Operation TrialBlazer Gets Right — And Where It Stalls (Part 1)")
Beyond The IND Clock: What Operation TrialBlazer Gets Right — And Where It Stalls (Part 1)The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But will it work? Kimberly Chew and Odette Hauke identify where the initiative succeeds and where the structural gaps begin.
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![IND clock (1)]( "Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2)")
Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2)The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But Kimberly Chew and Odette Hauke say its legal architecture is unresolved and reveals compliance issues that are hard to ignore.
SERVICES AND PRODUCTS
Cardinal Symptom Monitoring for Parkinson's and Huntington's Disease Trials
Continuous, objective tracking of cardinal symptoms in chronic diseases can support a better understanding of disease progression and treatment response.
Rapidly reduced timelines and waste, and the prevention of costly product shortages
In a world that is constantly changing, the development of innovative personalised medicine is helping more of us to live healthier lives for longer. These leaps forward in drug development create new hope for patients.
Yet operating high-value, time-sensitive supply chains naturally brings additional challenge and risk. Challenge and risk that require a step change in production approach to effectively balance patient-centricity with commercial viability.
Almac Trial Coordinator™ is a unified eClinical orchestration solution designed to simplify the execution of complex clinical trials. It brings together core trial functions including Interactive Response Technology (IRT), electronic Clinical Outcome Assessments (eCOA), eConsent, visit and participant management, and clinical supply oversight within a single, cohesive ecosystem.
Rather than operating as a collection of disconnected point solutions, Almac Trial Coordinator™ is designed to coordinate workflows, data, and users across the clinical trial lifecycle. The result is a more efficient, transparent, and site-friendly way to run global studies.
Boost patient engagement. Simplify and reduce site workload. Enable real-time, local currency payments through the patient’s preferred method.
Trial Enablement Solutions
Digital health technologies have the potential to transform clinical trials, yet without careful planning and operational support, their implementation can create complexity, increase site burden, and jeopardize data quality.
Backed by over 20 years of experience across nearly 300 industry-sponsored trials, Ametris’ Digital Health Operations team delivers end-to-end trial enablement services to ensure seamless technology deployment, reduce site burden, and capture reliable, high-quality data.
Ensure accurate, compliant, and impactful documentation with Altasciences' experienced medical writers and regulatory experts.