Current Edition

Volume 13 Issue 6

Querying the Queries – An AI Approach to Manage Clinical Data Quality

High-quality clinical trial data is essential for a successful clinical trial. This data is the foundation for the analysis, submission, approval, labelling and marketing of …

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Regional News

Pfizer’s COVID vaccine for younger kids meets FDA bar, with CDC panel next week being key to wide rollout

Kids ages 5-11 in the United States are now eligible for vaccination against COVID-19. On Friday afternoon, the FDA authorized the Pfizer-BioNTech mRNA vaccine, Comirnaty. …

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Regional News

AstraZeneca resumes asset sale in $270M COPD deal with familiar buyer Covis

Over the years, AstraZeneca has consistently adjusted its portfolio, targeting aging products. The company has now found a new home for two respiratory meds with an …

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Volume 13 Issue 5

Considerations for Clinical Trial Design Involving Radiotherapy

Radiation therapy has been used for many years as an effective form of treatment against many cancer types, yet it remains less well researched and …

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Regional News

Novartis’ Kymriah flops in earlier lymphoma use, where Gilead, Bristol Myers CAR-T rivals succeeded

Novartis’ Kymriah is losing its shot at a key market expansion opportunity in second-line lymphoma, where CAR-T rivals from Gilead Sciences and Bristol Myers Squibb …

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Regional News

Capturing The True Value of Patient Data By Aligning Stakeholder Incentives

Life science organizations and academic medical centers have an opportunity to advance scientific research by leveraging data, but there is one major roadblock: stakeholders have …

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Volume 13 Issue 4

Data Compliance or Rejection – Are you ready for September 15th?

Until recently sponsors have been able to submit nonclinical and clinical reports without datasets and without fear of rejection. In less than three months, the …

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Volume 13 Issue 4

Critical Considerations for Clinical Trial Safety Reporting Investments

Naturally, safety event reporting and pharmacovigilance (PV) should be subject to detailed regulatory scrutiny as evidenced by the Food and Drug Administration (FDA) overseeing the …

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Volume 13 Issue 4

Re-evaluating Paediatric Cancer Endpoints

The RACE for Children Act provides hope we can accelerate therapies to children, adolescents, and young adults with cancer. As precision medicine increasingly influences paediatric …

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Volume 13 Issue 4

Top 5 Innovations in Clinical Trials that are benefiting the Pharma Industry

The current pace and scale of innovation that we are witnessing within the pharmaceutical industry has not been seen before. The speed at which COVID-19 …

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