Stephan Ohnmacht, VP of R&D Business Consulting at Veeva Systems, explains how pharma companies can transform clinical development through smarter data, cultural change, and regulatory readiness.

Pharma’s long-held mantra  –  “ten years from lab to launch”  –  is under pressure. With clinical trial complexity mounting, AI on the rise, and regulatory oversight tightening, pharma companies are looking for ways to speed up drug development without sacrificing safety. According to Ohnmacht, doing that means looking beyond tech and into the human systems behind it.

“Technology alone isn’t the answer,” Ohnmacht explains. “It’s about how people interact with that technology, how they’re trained, how they feel supported. If we don’t bring the human element in early, we risk investing millions and not achieving any real change.”

Beyond software: Redefining pharma transformation

Veeva’s R&D consulting function doesn’t just help clients plug in new platforms – it engages before implementation to define a digital roadmap, train teams, and design change management plans that make transformation stick.

“We stay with clients through the full cycle: pre – implementation strategy, implementation execution, and post – implementation value realisation,” says Ohnmacht. “We help set KPIs, track efficiency gains, and make sure what was promised is actually achieved.”

It’s a response to a common industry mis-step: treating new technology as a plug- and-play solution. “There’s a perception that you can just rip out a system and drop in Veeva, and everything will magically work,” he says. “But without stakeholder alignment and cultural readiness, adoption lags. And adoption is everything.”

A culture of change – and care

Ohnmacht emphasises the need to engage leadership, middle management, and frontline users early in the process. Too often, transformation is done to people, not with them.

“I’ve spent over 20 years in the industry, and I’m always telling teams: change management is not optional. Communications matter. Culture matters.”

It’s also personal. In one striking moment during the interview, Ohnmacht reflects on a family loss from cancer – experiences that fuels his passion for faster access to treatment. “Pancreatic cancer took my dad in six months,” Ohnmacht says. “If we could shorten drug development by even that much, it would make such a difference, it’s literally life or death for some patients.”

Data, not documents: The shift driving modern R&D

Much of Ohnmacht’s work revolves around helping companies move from document-based systems to dynamic data models.

“Clean, interoperable data is the foundation,” he says. “Everyone wants AI, but AI’s only as good as the data it learns from. If you’ve got disconnected systems or messy inputs, it’s not going to work. So yes, we’re excited about AI – but it starts with getting the basics right.”

That groundwork includes ensuring different teams – regulatory, clinical, quality and looking at a single source of truth. Veeva’s Vault connections aim to eliminate duplication and create shared visibility across functions. But even with the right tools, Ohnmacht stresses that real transformation only happens when business processes evolve alongside the tech.

“If your SOP still tells someone to manually re-enter data, they’ll do it – even if the systems are connected,” he says. “So, we’re constantly aligning processes, tech, and people.”

Rising regulatory pressure: Clarity and complexity

Ohnmacht points to recent European regulatory changes – especially EMA’s adoption of ICH E6(R3) – as a major shift in sponsor responsibilities. “There’s no ambiguity now,” he explains. “Sponsors must have oversight of their CROs. They’re accountable.”

Tools like Veeva’s Clinical Trial Management System (CTMS) and Electronic Trial Master File (eTMF) allow smaller biotech firms, who often fully outsource trials, to retain visibility into what their CROs are doing. “These systems provide sponsors with the control they need to stay compliant while staying agile,” he says.

But regulation isn’t just about oversight – it’s also about opportunity. “When regulators define the rules clearly, we can build systems that respond to them efficiently,” he adds.

Measuring impact: From anecdote to analytics

Has this consulting-driven approach delivered measurable results? Ohnmacht is cautious about overstating claims. “One challenge is that many clients don’t have good baseline data from before implementation,” he says. “So, it can be hard to quantify the improvement.”

That’s changing with tools like Process Monitor, a new Veeva feature that will allow customers to compare operational efficiency across regions and teams. “You’ll be able to see, for example, how long study startup takes in say Italy versus the UK. That benchmarking can drive major efficiency gains.”

More importantly, Veeva’s frameworks help clients continuously measure KPIs that matter – like cycle times, submission speeds, or workflow bottlenecks. “It’s not about a shiny dashboard,” says Ohnmacht. “It’s about making smarter, faster decisions with real-world impact.”

The human cost of complexity

Another eye-opening section of the interview wasn’t about AI or software – it was about hospitals.

Clinical trial sites, Ohnmacht explains, are drowning in administrative burden. “We spoke to nurses who need 12 different passwords just to get through their day. Every sponsor has a different login, a different training portal, a different way of doing things. And they’re overwhelmed.”

This is more than a user experience issue. It’s a threat to trial quality and patient care.

“These are the people interacting with patients. If they’re buried in admin, that’s time taken away from care. Even small improvements – fewer logins, streamlined SOPs – can make a huge difference.”

He estimates the industry is only 5% into what’s possible for site support. “There’s so much more we can do, and Veeva is pushing hard to get there.”

Personalised medicine, data demands

As pharma shifts toward personalised medicine and complex biologics, data volume and complexity are exploding. But from Ohnmacht’s perspective, Veeva’s role doesn’t change.

“Our systems are data-agnostic,” he explains. “Whether it’s for a blockbuster drug or an ultra-rare genetic condition, we provide the infrastructure to capture, manage, and integrate the data that powers those innovations.”

He believes the rise of personalised medicine isn’t just exciting scientifically – it’s a moral imperative. “If we can develop therapies that not only treat but cure rare diseases, we have to do it. And we need systems that scale and adapt as we go.”

AI: A revolution – if we’re ready for it

Everyone’s talking about AI, but Ohnmacht urges caution and clarity. “AI is transformative, no doubt. But it can’t operate on junk data. That’s why foundational work – cleaning and standardising data – is our top priority.”

He worries that without proper oversight, AI could introduce more risk than reward. “In life sciences, we can’t afford to be wrong. We need strong partnerships with regulators to make sure AI is used ethically, responsibly, and safely.”

He also notes that some in the industry have a long way to go. “Paper isn’t dead,” he laughs. “We still see physical files in 2025. So, we have to meet companies where they are and help them build toward the future.”

Final thought: Time-to-patient is everything

What drives Stephan Ohnmacht isn’t efficiency for efficiency’s sake – it’s the patients waiting for hope.

“In some cancers, people live only six months after diagnosis,” he says. “If we can cut clinical development timelines by even six months, we give those people a chance. That’s why we do this work.”

For him, the urgency isn’t theoretical. It’s deeply personal – and it’s what makes pharma more than just another industry.

“Everyone in this space knows someone who’s been affected. That’s why we keep pushing. We owe it to them.”