As companies in the life sciences sector innovate at a more rapid pace than ever before, all while generating extraordinary volumes of data and navigating various regulatory dictates, data organisation has never been more critical.
Although next-generation applications for real time data processing like edge computing are emerging as alternatives to cloud computing that may supersede the technology in years to come, recent research has found that the overall cloud sector is continuing to boom, and grossed a record $84bn in Q3 2024, representative of a 23% increase on the same period in the previous year.
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Veeva Systems, an industry leader in cloud computing for the life sciences sector, utilised by leading pharmaceutical companies including Pfizer, Novartis, and 18 of the top 20 MedTech’s, is positioned as a multi-tenant cloud-based platform that aims to unify the clinical trial lifecycle for medical devices and pharmaceuticals, streamlining content and data management requirements, and improving operational speed to help organisations meet compliance measures like the EU’s Medical Device Regulation (MDR).
Veeva Vault is the company’s platform to manage data and content and features a range of applications for streamlining regulatory compliance, organising clinical trials, maintaining quality, and supporting medical affairs and marketing initiatives. Boehringer Ingelheim recently became the latest high-profile name to commit to adopting Veeva Vault as the commercial foundation for future expansions and launches of mission-critical applications.
Medical Device Network sat down with Seth Goldenberg, vice president, Vault Medtech, Veeva Europe at the recent Veeva MedTech summit, in Amsterdam, the Netherlands from 5-8 November, to discuss innovation and regulation in life sciences, and what a second Trump administration could mean for the sector.
Ross Law (RL): Why is cloud computing in life sciences important?
Seth Goldenberg (SG): Our goal is to be the operating system for the life sciences industry. Veeva is a multi-tenant cloud technology (a single cloud instance and infrastructure built to enable multiple cloud customers/tenants to efficiently share scalable computing resources in a public or private cloud), and with this setup, we all live in the Veeva skyscraper; each one of our customers has their own apartment and we all share the plumbing and the electric. Analogies aside, as we put around 40% of our revenue into R&D, this setup means that all of this goes into innovation. This is possible since our platform is not a hosted cloud solution build like more traditional firms out there, so we are free to put our R&D spend into innovation, opposed to maintaining and managing software.
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By GlobalDataRL: How do you decide on the direction innovation should move in?
SG: It really is our customers who drive our innovation. We’ll identify a market opportunity to get started in, and we will see an area that’s underserved, or an industry that’s underserved, like medtech, and get going on that journey. Once we’re in there, our cycle of engaging with customers, getting them direct lines to product for feedback, to then drive that innovation, is how we make this decision.
RL: Can you speak about any current adoption trends throughout Veeva Vault? Is there anything in particular that medtech customers are requesting more of?
SG: When you’re a medtech, even if you’re a relatively small team, you have a huge number of SKUs, a huge number of products relative to a similarly sized pharma.
That’s a common area where a lot of our customers start, and it’s continuing to accelerate. Where we’re seeing a lot of interest right now is on post-market quality (PMQ). Some of that’s driven by the EU MDR, but PMQ is a huge area of interest in general because, historically, medtech companies have to do patient safety where the reporting timelines are getting tighter. As a lot of these companies grow through acquisition, they may have as many as 100 QMS’s, and they can’t get access to that information in real time, which is an area in which we can assist.
RL: What do you make of the EU MDR and the challenges being faced by some around meeting its compliance requirements?
SG: Over the last couple of years, companies were focused on getting ‘MDR ready’, and that centred around them figuring out how to get their tech files prepared to meet the new requirements for review by the notified bodies. We’re now entering this next phase in which companies are thinking about how they can be ‘MDR sustainable’. I think this is where a lot of them are struggling because they’re collecting data from many different sources, there are different groups that typically do not work together involved in this, and in putting these pieces together, companies are realising that their current structures, operations, tools, and staffing are insufficient to be sustainable under MDR.
Add to this the moving target of various regulations and shifting deadlines, the entire process has grown incredibly complex and challenging for most.
RL: What actions need to be taken to improve diversity in decentralised clinical trials (DCTs)?
SG: Health equity is something that we’re very interested in. Most clinical trials take place in tier one medical centres and trend towards a certain socioeconomic population, whereas if you want to reach those groups that are outside, to get more real world-like evidence, you have to figure out where they are and whether a trial can actually be run at a given site because they are usually site-immature.
We have solutions that support the targeting piece, with our deep data tools that help people doing work within these populations. Then you have to help make it easy for sites to execute a trial, which is something our Site Vault application can help with.
A lot of the time, the clinical trial burden on the patient is not something people think about as much. There’s a whole lot of socioeconomic and gender equality stuff that falls into that part of the puzzle, around issues like who can actually take time off work, and that’s also why we have a patient app, Veeva ePRO, so patients don’t necessarily have to go in to the doctor’s office for all the follow up and can do some of it virtually, and then we can also help with remote monitoring of data, too.
Overall, the matter of improving DCTs is a complicated proposition. You need to address a lot of different pieces. You have to think about that whole ecosystem of finding the sites, making it easy for the sites, the burden on the patients, and still making sure the sponsor can execute a good clinical trial, which is harder for medtech because, in contrast to pharmaceutical clinical trials, there’s a lot more follow up, and physician training has a huge impact on results for medtech organisations. You need to engage them. You need to train them, and we help address this in a lot of different ways, but it’s really that whole ecosystem that needs to be supported, including the data part on the front end.
RL: How do you foresee President-elect Donald Trump’s return to the White House impacting the life sciences industry?
SG: I think a key way in which a second Trump term may affect life sciences is deregulation. From the commercial side, the potential risk to the US would be in any cuts in funding to basic research that runs through the National Institutes of Health (NIH), although, unfortunately, it would take five-to-ten years to really determine what the impact if any such cuts are made would be. In other areas, for now, let’s just say that’s TBD.
