Clinical trials are often the biggest bottlenecks in the drug development process. Getting them completed faster and more accurately, and collecting precise data while controlling costs, are industry imperatives.
The extent of clinical trials’ importance are reflected in GV’s (formerly Google Ventures) interest in them. David Schenkein and Krishna Yeshwant, both physicians who lead the life sciences team at GV, want to revolutionize the process, they told Business Inside recently. They might invest in an existing clinical trials company, or start an entirely new one. “There’s a lot of infrastructure that needs to be built in order to start talking about machine learning in clinical trials, in clinical data. And so we’re well down the path of working on companies in that space.,” Yeshwant said.
Veeva Systems (NYSE; VEEV), with its market value approaching $25 billion, maintains its strong growth rate by having a fruitful ongoing product development pipeline. With the success of its Veeva Vault clinical information offering, itself organically developed and now accounting for a a majority of its revenue, a lateral move into clinical trial technology was inevitable and logical. Shared customers, shared expertise, and shared costs with its existing business all pointed that way.
Veeva already had developed one key asset for this, an application named eTMF (electronic Trial Master File), that is instrumental in digitizing the information collected in a trial. In some cases, eTMF replaced completely paper-based systems.
I spoke with Henry Levy, general manager, Veeva Vault CDM, about Veeva’s progress with its Veeva Vault Clinical Data Management System (CDMS) , a relatively new offering. Levy joined Veeva in late 2016 to head up its new CDMS efforts, following extensive experience with Accenture Life Sciences and a major CRO (contract research organization).
Levy, by the way, came to the US by way of Colombia and holds a bachelor of science degree in bioengineering from Penn. He has studied the Clinical Trials industry inside and out and probably knows his way around it as well as anybody.
You could hold an impromptu forum of CTMS industry leaders at a Main Line coffee spot. Philly is probably the capitol of the clinical trial tech industry, although actual trial activity itself is more dispersed. So despite Veeva’s headquarters being in California, the bulk of its CTMS initiative has been managed from its Radnor office were Levy is located.
Veeva sees the CTMS market as a $1 billion TAM (total addressable market) opportunity, Levy says, not that it expects to capture all of that, but hopes to have a significant share within 3 years in some segments. Veeva sees a total adressable market of $9 billion now for its entire enterprise, so it obviously considers the CTMS opportunity significant.
Veeva reported having 34 CTMS clients at the end of 2918, twice as many than at the end of 2017.
The current CTMS market is probably well in excess of $500 million and growing at a double digit annual rate for the next several years. Market size can be difficult to pin down due to the amount of trials conducted in house and the task of defining what revenues should be included as relevant. Recent IPO SmartSheet, for example, touts its product for CDMS use, but its difficult to quantify its use for that.
Veeva emphasizes these benefits from Vault CTMS:
- Better decision making: Enable proactive closed-loop issue management and improve strategic trial planning with a complete real-time view of trial status.
- Streamlined clinical operations: Provide one seamless system of record for shared CTMS, TMF, and study start-up content, improving efficiency and streamlining operations.
- Unify clinical: Leverage the most comprehensive suite of clinical applications on a single cloud platform to unify clinical operations and data management.
Unification of data and the elimination of silos are emphasized here as throughout Veeva’s product line
Veeva’s Vault CTMS product offering is self sufficient so that in some cases it can give clients an end-to-end technology package and let them go at it, while offering tech support. For others, Veeva will assist in trial management to the extent needed, Levy said.
In April, Veeva announced that a top 20 pharmaceutical company has selected Veeva Vault Clinical Data Management System (CDMS) as their global standard for EDC, coding, data cleaning, and reporting.
The competitive landscape is changing, with more consolidation and strategic moves to strengthen some market participants’ positions. Bracket bought CRF Health and became Signant Health, Dassault spent $5.8 billion to acquire Metadata in June, Oracle bought GoBalto, and IQVIA, formed through the merger of IMS Health and Quintiles, has made several niche acquisitions towards boosting its clinical trials capabilities.
When I mentioned GoBalto, a startup which uses data sources to seed trials more quickly with the desired population characteristics, Levy admitted that was a big win for Oracle. Which made me wonder whether Veeva, which has been very constrained on acquisitions in general, had been in the running for it. Levy told me he prefers organic growth.
There will always be room for niche specialists in clinical trials. For instance, Malvern-based Biotelemetry and Philly-based ERT both run cardiology trials, and Newtown-based BioClinica specializes in applying imaging to trials. But across verticals, there are common needs that can be addressed by a single, unified platform. The race is on to see who can do it best, and based on its track record I wouldn’t bet against Veeva.