Tackling Clinical Trial Data Overload with Data Lakes and Machine Learning

October 31, 2019

Clinical trial data come from many different clinical (i.e. EDC, eCOA, lab, ePro, EMR/EHR, biomarker, mHealth / IoT), and operational (project management, eTMF, regulatory, financial, employee) sources and formats.

Spotlight

AJ Vaccines

AJ Vaccines produces and sells vaccines from the production site in central Copenhagen. The production is taken over from SSI, and was until January 2017 owned by the Danish Government. AJ Vaccines has thus taken over a company with a very proud history of vaccine manufacturing

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Four best practices for single-use supply chain success

whitePaper | February 16, 2023

Flexible and cost-effective, single-use technologies offer biopharmaceutical companies a way to transform their biologics production and meet the growing demand for these life-changing therapies.

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A Comparison of Substance Use Disorders before and during theCOVID-19 Pandemic

whitePaper | September 22, 2022

During the COVID-19 pandemic, drug overdose deaths have increased. At the same time, access to and utilization of substance use disorder treatment services have decreased.

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Getting serious about serialization: A comprehensive look at thelegislation shaping U.S. pharmaceutical supply chains

whitePaper | October 7, 2022

The Drug Supply Chain Security Act is one component of the DQSA. This particular act requires the FDA to implement a national track-and-trace system by which manufacturers must affix product identifiers (barcodes) to each package of product that is introduced into the supply chain.

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Medical Afairs Transformation in Specialty Pharma

whitePaper | March 6, 2022

Pharmaceutical companies with a medical mindset and an empowered Medical Afairs function are well equipped to meet the needs and expectations of patients and society. Yet, as capacity to understand and serve those needs accelerates.

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QbD and PAT in Biopharmaceutical Development

whitePaper | July 12, 2022

As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA ’s process validation (PV) guidance (1) and International Conference on Harmonization.

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Asia Pacific as a Clinical Trials Powerhouse

whitePaper | October 6, 2022

Patient availability is a critical component for clinical trials, and so it stands to reason that clinical development should match the epidemiology of diseases. Of course, this is often not the case,

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Spotlight

AJ Vaccines

AJ Vaccines produces and sells vaccines from the production site in central Copenhagen. The production is taken over from SSI, and was until January 2017 owned by the Danish Government. AJ Vaccines has thus taken over a company with a very proud history of vaccine manufacturing

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