Avril England, general manager of Vault, Veeva Systems, presenting at the Veeva R&D Summit being held in Madrid on 4 and 5 June 2024. Image credit: GlobalData.

In a tech-heavy world, the use of automation and AI is now the key to further speeding up processes in clinical trials and drug development.

A key theme from the first morning of the Veeva R&D Summit, taking place at the Marriott Madrid Auditorium on 4-5 June 2024, was the need to use automation and AI to further expedite the development process. This is needed in regulatory filing, data processing, quality control and more.

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Speaking exclusively to the Clinical Trials Arena, Mike Edwards, director of Batch Release strategy for Veeva, said that currently, much of the processes of assessing quality control in drug manufacturing, even within big pharma, is paper-based. This leads to slow quality control procedures which for some diseases can be critical.

“The speed needed with CRISPR therapies and gene editing therapies is minute by minute, hour by hour, to get that medicine 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 over? What data can we get from the patient?’ That’s currently very manual. We need however to get that data to the right person as quickly as possible.”

Veeva’s Batch Release, set to be released in December 2024, will aggregate, review and trace batch-related data and content to enable faster, more confident good manufacturing practice release.

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Elsewhere in the field of automation, Avril England, general manager of Vault, spoke during the opening keynote session about how automation can assist with flagging questions raised by regulators in trial submissions.

Veeva has implemented a new feature to its regulatory system, Vault RIM, which allows users to annotate emails from regulators, with the notes then being used to create data records so that the regulator’s concerns can be addressed. England goes on to add that AI could also be helpful in this model.

England asks: “AI will play a logical role here as well. Could we use an AI tool to help assess what should be highlighted and making it another step easier?”

The European Medicines Agency (EMA) will require all trials to be transferred to the Clinical Trial Regulation (CTR) from 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, however, the reception overall by the industry has been positive.

These are not the only areas in which AI and automation are being utilised in clinical trials. Companies are using such technologies to support data collection and data processing, including the transfer of patient data from electronic health records to electronic data capture, something that had previously been done manually.