Veeva Brings AI to Drug Safety
Veeva Systems has announced Veeva Vault Safety.AI, a new artificial intelligence (AI) application that automates case intake to reduce the time and effort of manual data entry for case processing. Together with Vault Safety and Vault SafetyDocs, Veeva offers an integrated suite of cloud applications on a common platform to manage the end-to-end drug safety lifecycle, from case intake and adverse event processing to authoring and submissions.
“There is a significant opportunity to reduce the number of manual processes in drug safety,” said Dr. Lisa Hornick, chief medical officer at Catalyst Clinical Research, a global CRO providing clinical research solutions to the biopharmaceutical industry.
Life sciences companies are collecting an increasing volume of adverse events from an expanding number of sources, including social media, fax, email, literature, and call center notes. Safety.AI reduces manual data entry during case intake by converting text from these sources into the required fields in a drug safety case, including patient information, adverse events, medical history, products, and reporter information.
“The high cost and manual effort of case intake processes are no longer sustainable, making it an area that is ripe for innovation,” said Brian Longo, SVP & GM, Veeva Vault Safety. “Veeva Vault Safety.AI automates data entry so medical professionals can focus their efforts on verification and pharmacovigilance organizations can drive greater efficiency in drug safety operations.”
Safety.AI is planned for availability in April 2020.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
