In a world full of technology, the use of automation and AI is now the key to further accelerating processes in clinical trials and drug development.
A key theme of the first morning of the Veeva R&D Summit, which took place at the Marriott Madrid Auditorium on June 4-5, 2024, was the need to use automation and AI to further accelerate the development process. This is necessary for regulatory registration, data processing, quality control and more.
Speaking exclusively with the Clinical Trials Arena, Mike Edwards, director of Batch Release Strategy for Veeva, said that currently many of the processes for assessing quality control in drug manufacturing, even within major pharmaceutical industries, are paper-based. This leads to slow quality control procedures that can be critical for some diseases.
“The speed required with CRISPR therapies and gene editing therapies is minute to minute, hour to hour, to get that drug to the patients, and of course with gene editing it comes from the patient to begin with,” Edwards said.
“It’s the process of ‘how quickly can we ship that? What information can we get from the patient?’ That is currently very manual. However, we need to get that data to the right person as quickly as possible.”
Veeva’s Batch Release, due in December 2024, will merge, review and track batch-related data and content to enable a faster, more confident release of good manufacturing practices.
Elsewhere on the automation front, Avril England, managing director of Vault, spoke during the opening keynote session about how automation can help identify questions asked by regulators in trial submissions.
Veeva has implemented a new feature in its regulatory system, Vault RIM, that allows users to annotate emails from regulators, with the annotations then used to create data records so that the regulator’s concerns can be addressed. England adds that AI could also be useful in this model.
England asks: “AI will also play a logical role here. Can we use an AI tool to help assess what needs to be emphasized and make it one step easier?”
The European Medicines Agency (EMA) will require that all studies be transferred to the Clinical Trial Regulation (CTR) of the Clinical Trials Directive (CTD) by the end of January 2025.
During this process, sponsors have spoken about several pain points they have faced with the new filing system, but industry reception has been generally positive.
These aren’t the only areas where AI and automation are being used in clinical trials. Companies use such technologies to support data collection data processingincluding the transfer of patient data from electronic medical records to electronic data collection, something that was previously done manually.
“Veeva R&D Summit: Automation and AI Key in Improving Development Speed” was originally created and published by Clinical Trials Arenaa brand owned by GlobalData.
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