Is Veeva Vault RIM the Defacto Regulatory Information Management Solution for Emerging Biopharma?
The market for Regulatory Information Management solutions has never been so active. In the last 2-3 years, and in the coming 12-24 months, a significant number of small, mid-size and large biopharma has refreshed or will refresh their Regulatory Information Management (RIM) technology foundation. These refreshes are unlike the laborious upgrades of the past, where point solutions for specific capabilities (submission planning or content creation or publishing) were in regular, often unsynchronised update cycles, which ultimately yielded some capability improvements but rarely made much end-to-end business impact.
In contrast, recent and current RIM transformations have focussed on a process-led approach, looking for real opportunities to streamline and optimise global regulatory process for measurable business benefits, driven by the availability of end-to-end RIM suites and the maturity of digital technologies to automate both processes (business process management/workflow) and repetitive tasks (robotic process automation).
There is no doubt that Veeva Vault RIM has emerged as the clear market leader underpinning this new wave of RIM transformations, and Veeva’s relentless dedication to the continuous improvement of the Vault platform and applications will solidify this market position for many years to come.
Emerging biopharma
Consulting companies such as Syneos Health have done a brisk business in RIM Transformation investment cases, software choices and RFP processes in the mid and large biopharma segment as these RIM transformation projects have come to life. Larger and complex organisations have a multitude of factors influencing the final decision on the choice of software, including regulatory organisation design and history, complex legacy process, diverse product portfolios, legacy point solutions, large migration burdens, M&A integration factors, IT strategy and platform/data consideration to other functions like Quality & Clinical. However, for emerging biopharma, unencumbered by this historical baggage, is there any value in spending money choosing a new RIM tool, when the benefits of taking the market-leading tool are so obvious?
Earlier in 2020, an emerging biopharma approached Syneos Health Consulting for just such a RIM vendor evaluation project, and as diligent consultants, a client proposal was prepared. However, in discussions between the client senior leadership and our R&D Advisory leadership, it became obvious very quickly that this expenditure was better directed at simply scoping and delivering a Veeva Vault RIM program. Why would a consulting company turn down this project revenue? Simple, it was the right thing to do for the client and built trust with the client that we were acting in their best interest.
What factors lead to this decision?
Business process considerations
The RIM solutions on the market today vary in terms of capability and functionality maturity. In Veeva’s case for example, the Publishing solution is still maturing although all global publishing output types should now be available in Veeva Vault RIM by the end of 2021. However, the strength of the Registrations, Submissions and Submissions Archive modules, and the availability of “black box” publishing tools that can be integrated, is a strong mitigation factor here, especially for emerging biopharma where the annual submission volume is very low. Other end-to-end solutions with potentially greater functionality may not always be as mature as the sales pitch suggests, or these solutions require extensive client configuration or client input to get to the right level of capability.
Another significant factor is the extensive Veeva Vault RIM install base across large and mid-size pharma. The complexity of these larger organisations and their proactive involvement with Veeva to inform the ongoing development and release cycles is a huge benefit to the emerging biopharma sector. They can rest securely in the knowledge that Veeva will release new functionality every 4 months; this functionality will be well tested and driven by global client requirements, yet the emerging biopharma gets all the benefits without the overhead. Veeva Vault RIM is Software as a Service (SaaS), therefore all Veeva Vault RIM clients get the same functionality (yes, you can configure it differently) – to paraphrase Henry Ford, you can have Veeva Vault RIM in any colour so long as its Orange!
Lastly, the speed of implementation is a big benefit, although there can be a danger in going too fast, with IT orientated “quick start” packages sometimes proving counter-productive in the mid to long term. Rushing into a new technology solution implementation, without first aligning the internal stakeholders on the business benefits and changes to existing manual and uncontrolled practices, can lead to a sub-optimal deployment and user disillusionment.
The ability to adopt Veeva’s out of the box functionality and standardised methods for planning and execution of global regulatory submissions affirms our belief that Veeva Vault RIM is the defacto choice for the emerging biopharma sector from a business process optimisation perspective.
Technology considerations
A RIM vendor evaluation would assemble the usual cast of characters in the RIM space, and there are many good options. However, for an emerging biopharma, a true cloud solution with zero infrastructure footprint is very attractive, added to the potential benefits of a platform solution across Clinical, Quality, Medical Affairs and Commercial. Of course, Veeva is not the only cloud solution on the market, but it is the leading one.
The availability of “Quick Start” packages from Veeva can be particularly attractive to IT functions, but as previously mentioned, there is a danger that this approach does not ultimately deliver the right benefits to the client. Nevertheless, just having this well thought out, consistent technology deployment approach is still a significant accelerator.
The lack of legacy system investments to consider and a usually small data volume for migration, further points to the IT benefits of choosing Veeva. The IT security, performance and resilience of Veeva is already proven at scale, with large and mid-size pharma having audited Veeva on numerous occasions, and these large global organisations are already reaping the benefits of Veeva’s robust, secure, high-performance global infrastructure.
For these reasons, from a technology perspective, Veeva Vault RIM is a very attractive option in this emerging biopharma sector.
Timing, scalability and future success
In the emerging biopharma sector, the timing of a RIM investment is critical. We usually see the investment made when the leading compound has moved into Phase III development, and the prospect of multiple, global MAA/NDA is looming (the IND/CTA submissions having been handled manually). The size and quality of the emerging pipeline, and the realisation that the processes and ways of working used for the leading compound are just not scalable across a wider product portfolio is also a driving factor in the timing of the RIM investment. In addition, as the leading compound gains regulatory approval, this will lead to an explosion in lifecycle management submissions. All of these factors point to the requirement for scalable global processes supported by reliable and well-proven RIM technology foundation.
But….there is always a but
There is a perception in the market that Veeva is expensive. It is certainly true that a single monthly or annual fee that bundles licensing, maintenance, support and infrastructure can look very costly at first glance. In mid and large pharma, with legacy systems deployed in a mixed CapEx and OpEx model, moving to a new, fully OpEx cost model can certainly seem expensive. It is important in those companies to calculate the true total cost of ownership of legacy solutions and potential future options. We will not explore this financial modelling further here, but if you need further information please contact the author. For the emerging biopharma sector, we contend that this fully “pay by the drink” transparent cost model is actually preferred, because any investment in alternative solutions would undoubtedly require widespread IT infrastructure investments not required when adopting Veeva.
There are multiple RIM technology options in the market and these continue to mature in terms of functionality, performance and client adoption. At Syneos Health Consulting, we refresh our view of the market multiple times per annum, as we continue to work with our clients in emerging, small, mid and large biopharma. There is no doubt that some companies will choose a different path, and new paths will emerge as the market and the macro regulatory and technology environment continues to evolve.
Conclusion
For all of the reasons outlined above, we stand by our contention that Veeva is the defacto standard for the emerging biopharma sector, and we do not see this position changing for at least another 18-24 months. We would be delighted to discuss and debate this topic with you during this Veeva R&D conference and beyond.
About the Author
John Cogan is the Executive Managing Director and Global Practice Leader at Syneos Health Consulting, R&D Advisory. He has spent the last 30+ years in the Life Sciences sector, in both industry and consulting, including roles in Regulatory Operations, R&D IT, IT Shared Services, CTO and Consulting leadership. He is a recognised industry expert in Regulatory Information Management and business process transformation, has co-authored papers with leading analysts including Steve Gens, and speaks regularly at industry and technology vendor conferences on these topics. [email protected]
