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FEATURED ARTICLES
What The New PDUFA Guidance Means For Drug Development
Learn how the FDA’s updated PDUFA meeting guidance affects sponsor engagement, preparation, and the way feedback shapes drug development.
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![Build business framework, teamwork help development growth, improvement process, planning together-GettyImages-2226781046]( "Founders, Fortitude, And Clinical Trials")
Founders, Fortitude, And Clinical TrialsAfter talking with six clinical trials-related company founders, I came away admiring the tenacity, fortitude, and curiosity it takes to turn an idea into a business — and keep it going through setbacks, uncertainty, and constant change.
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![new reg part 2 - GettyImages-1366013071]( "Get Ready For Regulators With This Speed-Quality-Compliance Framework")
Get Ready For Regulators With This Speed-Quality-Compliance FrameworkPart two of a two-part series, experts Sapna Rani and Shaun Hastings offer a five-part framework to balance speed, quality, and compliance amid evolving clinical trial regulations.
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![new reg part 1 - GettyImages-1366013071]( "The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?")
The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?Part one of this two-part series explores how clinical trial regulation aims to balance speed, quality, compliance, and digital innovation.
SERVICES AND PRODUCTS
Support proof-of-concept trials with integrated clinical and CRO capabilities spanning study design, site selection, patient recruitment, monitoring, and data delivery.
Support proof-of-concept trials with integrated clinical and CRO capabilities spanning study design, site selection, patient recruitment, monitoring, and data delivery.
With over 40 years of expertise in cold chain management and a global network of trusted partnerships, we safeguard the integrity of your ultracold supply chain, providing real-time monitoring and assurance for dependable sample storage.
For over 35 years, Thermo Fisher Scientific has supported the clinical trial supply, distribution, and logistics needs of pharmaceutical and biotechnology sponsors globally.
At the center of every clinical trial is a patient waiting for a treatment to arrive safely, securely, and on time. Clinical trial supply services make that possible by ensuring investigational medicinal products (IMPs) are packaged, labeled, stored, and distributed in full regulatory compliance across global study sites
Explore the breadth of Altasciences’ expertise in clinical pharmacology studies, supporting regulatory submissions across a diverse range of therapeutic areas.