Enabling Data Integrity from Drug Discovery through Manufacturing

| September 6, 2018

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When discussing the success of a drug therapy, a common topic amongst biopharmaceutical companies is data quality and data integrity; what the challenges are and what the key elements are to ensuring that the latest discovery is patentable, does not result in re-conducting critical research or development studies, is accepted by the regulators, or does not result in a recall of a batch of product.

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MENARINI Group

The Menarini Group is the leading Italian pharmaceutical company in the world, a guarantee of internationally recognised quality. The achieved results are proof of an efficient strategy based on Research, Innovation and Internationalisation, along with the ability to recognize and meet the needs of physicians and patients alike.

OTHER ARTICLES

Comparing HydroxyChloroquine Trials

Article | April 1, 2020

One minor side effect of the pandemic is that perhaps more people will learn about what drug research and clinical trials can really be like. Today’s example: we have a clinical trial of hydroxychloroquine from Wuhan that has just published on a preprint server. What’s good is that this one is blinded, randomized, and controlled (like the earlier hydroxychloroquine which one I blogged about here from Zhejiang University, so we can actually talk about it rather than just spend all our time wondering what the heck is going on.

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Clinical Supply Availability & Speed to Study Start-Up

Article | April 1, 2020

If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy. That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete.

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Top Pharmaceutical Firms Urge FDA to Adopt Blockchain for Drug Tracking

Article | April 1, 2020

Leading market participants in the United States pharmaceutical industry, logistics firms, distributors and other stakeholders in the pharma supply chain have come together to publish a report buttressing the need for industry players to adopt blockchain for tracking prescription drugs, following the successful completion of a DLT pilot project with the Food and Drug Administration (FDA), according to reports on February 24, 2020. Though nascent, blockchain technology, the building blocks of Bitcoin (BTC) and other cryptocurrencies are fast gaining ground across various ecosystems, due to its immutability, security, privacy, and other intricate properties. In the latest development, 25 leading manufacturers of pharmaceutical products, logistics partners and other market participants in the pharma supply chain, have published a report that highlights the importance of blockchain technology in drug traceability.

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How AI and Big Data Will Disrupt Pharma’s Regulatory Compliance Standards

Article | April 1, 2020

The industry as we know it is changing. Pharmaceutical and life sciences companies across the globe are experiencing more pressure than ever to keep up with increased regulatory standards while moving at a pace that requires them to innovate in order to remain competitive. With more real-time automation and the steady increase in AI and Big Data sweeping the landscape, what used to be a slow-to-change and risk-averse industry is now expected to see a significant shift towards newer technology that focus on heightened regulatory standards. Here’s how your company can get ahead of what industry experts are calling, Pharma

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Spotlight

MENARINI Group

The Menarini Group is the leading Italian pharmaceutical company in the world, a guarantee of internationally recognised quality. The achieved results are proof of an efficient strategy based on Research, Innovation and Internationalisation, along with the ability to recognize and meet the needs of physicians and patients alike.

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