CONFERENCE COVERAGE | Veeva Keynote
A drug entering the clinic today takes ten years to reach regulatory approval. A decade ago, it took eight. That statistic, delivered by IQVIA’s Brian O’Dwyer at the Veeva R&D and Quality Summit in Boston, framed the keynote’s real argument: an industry that cannot standardize its work cannot automate it.
An Industry Ripe for New Ways of Working
Citing IQVIA Institute and Tufts data, O’Dwyer noted that the industry, coming out of the pandemic, now takes ten years to move a drug from clinic entry to regulatory approval, a dis-improvement from eight years a decade ago. Given the evolution of science, medicine, and technology over that same period, he called it surprising that the industry has driven such inefficiency into the process.
The sources of that inefficiency are familiar: sites retype paper data into EDC systems, sponsors check the retyping, and thousands of documents a day are manually classified, filed into TMFs, and quality-checked, with nearly every company doing it differently.
Veeva CEO Peter Gassner was blunter, likening the industry’s accumulated habits to purple hats that everyone keeps wearing without remembering why they put them on, and stressing that the industry can simply take them off.
Regulators are pulling in the same direction. ICH E6(R3), now in effect across major regions, expects risk-based quality management and proportionate oversight which is hard to deliver from disconnected systems, and Veeva is building RBQM capabilities directly into its clinical systems in response.
The Standardization Thesis
Gassner’s reference point is the standard shipping container, which revolutionized global trade because every trucker knew what they were picking up, and he indicated that Veeva intends to do the same for life sciences.
The concrete expression is Veeva Study Suite, which packages Veeva’s clinical applications to be bought and implemented study by study, integrated out of the box. When a CRO runs the study, data transfers back to the sponsor’s eTMF and CTMS daily. For sites, the pitch is one login, one data flow, and one support team to call.
The packaging is aimed squarely at the growth curve. A scaling sponsor can start on a single study and bring work in house gradually; an emerging biotech can simply ask its CRO to run the suite, with the TMF transferring home either way.
Vault AI and the End of Token Counting
The biggest AI announcement was a price. Vault AI, the conversational and agentic layer now live across Veeva’s applications, will cost 10 percent of a Vault’s subscription, 5 percent in the first year, with unlimited usage. Gassner quipped that no one ever moved the industry forward by counting tokens.
The structure matters more than the discount. Token-metered pricing has turned AI adoption into a budgeting exercise across the industry, and a flat fee moves the efficiency burden onto Veeva, which now carries its own incentive to run the models economically.
Veeva’s EVP and general manager of Vault products Avril England demonstrated it as a study country manager preparing a weekly CRA meeting: enrollment by site, aging EDC queries, RTSM supply checks, and the right SOP pulled from a connected Quality Vault, then the whole routine saved as a scheduled personal agent through Shortcuts, arriving in April with the 27R1 release. Queries execute with the user’s own permissions, so the AI cannot surface data its user could not already see.
With 750,000 people in Vault on an average workday and roughly 250,000 reports run every day, the audience is not hypothetical.
Falcon Agents: Labor, Not Features
Vault AI helps users do the work. Falcon agents, the second half of Veeva’s AI strategy, does the work, including clinical intake and TMF filing, the standardized portion of site monitoring, triage of inbound health authority questions, and drafting of clinical study reports.
The writing agent is the most ambitious of the set. It starts with clinical study reports, and Gassner acknowledged that Veeva will likely rework its RIM application to feed it better information.
Falcon is under a year old and in early adopter mode, but the dependency already runs in one direction. An agent cannot file documents into fifty differently configured TMFs. Standardization is the price of admission.
Biogen: A Thousand Change Agents
Biogen brought the sponsor’s view. Tara Aldoory, who leads clinical operations at the company, described a portfolio diversifying from neurology into nephrology, immunology, and rare disease while going live on Veeva’s clinical, safety, and quality Vaults. The company has reorganized along the way to reduce handoffs.
Aldoory indicated that all of Biogen’s more than one thousand people in development are change agents, and that becoming familiar and comfortable with data, whether five or 25 years into a career, is now central to how the company delivers trials.
IQVIA’s Seven-Month Bet
IQVIA, which runs roughly 2,000 trials at any time across more than 50 countries, is adopting Veeva’s study startup, CTMS, eTMF, and Site Connect applications as its enterprise standard. The timeline is aggressive: all four modules within seven months, with every new IQVIA study on the platform from the third quarter of next year.
The commitment carries weight because of who is making it. IQVIA employs 90,000 people, 60 percent of them in its clinical organization, with data assets spanning 1.2 billion real-world lives.
O’Dwyer indicated that some 30,000 people at IQVIA will ultimately touch Veeva applications through the deployment and beyond and characterized the program as ambitious but one the company is confident in, with the potential to change the industry.
The Takeaway
For all the product news, the Summit’s story was sequencing. Drug development did not slow from eight years to ten for lack of intelligence. It slowed because every sponsor, CRO, and site built its own version of the same work. Agents are merciless about non-standard work, which is why Biogen and IQVIA are standardizing first. Getting the two lost years back will depend less on the models than on how fast the rest of the industry follows.
This article is sponsored by Veeva Systems
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
