Clinical Development

FDA rebuff for Keytruda in breast cancer indication

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A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the companyâs application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.

Inside the Pfizer/BioNTech COVID-19 vaccine trial: ‘We knew the world was watching and waiting for results’

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The 2020 Pfizer/BioNTech COVID-19 vaccine trial recruited more than 44,000 participants and reached submission for emergency authorization in 248 days: showing unprecedented speed and agility in the context of a global pandemic. So what have been the learnings from the trial â and how could… Read More »Inside the Pfizer/BioNTech COVID-19 vaccine trial: ‘We knew the world was watching and waiting for results’

Evidera launches OffTheShelf ™ for historic patient data

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Learn more about the detailed patient points and associated physician data available from OffTheShelf. View our infographic. http://bit.ly/evidera-offtheshelf Highlights about OffTheShelf™: Understanding the market trends, market behavior, and competition when developing oncology therapies is critical to optimize market access and product uptake OffTheShelf™ provides access… Read More »Evidera launches OffTheShelf ™ for historic patient data

hyperCORE names new CEO

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The clinical research site network has tapped 22-year industry veteran Karri Venn, president of research with LMC Manna, to lead the organization.

Sharp introduces clinical trial IMS

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The Clinventory inventory management system is designed to help study sponsors streamline management of their clinical trial inventory and supplies.

PRA: get ready for the RACE Act

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Experts from the CRO offers insight on preparing for the changes to the pediatric oncology research requirements, which take effect next week.

US FDA’s Coronavirus Treatment Acceleration Program (CTAP): Strategic Considerations for Investigational COVID-19 Drugs, Biologics, and Treatment Vaccines

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Click here to download printable PDF The Coronavirus Treatment Acceleration Program (CTAP) is a special emergency program instituted by the US Food and Drug Administration (FDA) in response to the COVID-19 pandemic The primary goal of the program is to expedite the availability of new… Read More »US FDA’s Coronavirus Treatment Acceleration Program (CTAP): Strategic Considerations for Investigational COVID-19 Drugs, Biologics, and Treatment Vaccines

A Systematic Approach to Assessing Real World Research Questions Supported by Digital Enablement

Download the white paper now https://bit.ly/evidera-digena Multiple strategies, each with their individual advantages and drawbacks, may be employed to answer a research question, but determining the optimal strategy – the one that will bring you to your answer in the most effective and efficient way possible – that is… Read More »A Systematic Approach to Assessing Real World Research Questions Supported by Digital Enablement