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COVID-19 Trial Changes Are "Propulsive Force" For Digital Adoption

 
• By Cole Werble

Robert Califf, a former FDA commissioner turned Verily Life Sciences exec, is just one of the voice predicting a long-term impact on clinical trial processes from the COVID-19 outbreak.

Current and former US Food and Drug Administration officials are expressing broad agreement that COVID-19 will likely be a prod to the wider-ranging acceptance of digital health information from clinical trials.

The practical difficulties of collecting information at specific sites during the mobility restriction of the SARS-CoV2 pandemic are acting as...

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More from Digital Technologies

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

More from Advanced Technologies

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
• By Aakash Babu

Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
• By Francesca Bruce

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.