The Move to Digitally-based Clinical Trials Heats up Competition & M&A as WCG Buys Trifecta: What’s a Pharma Buyer to Do?

The Move to Digitally-based Clinical Trials Heats up Competition & M&A as WCG Buys Trifecta What’s a Pharma Buyer to Do TrialsiteN

WCG continues its expansion into technology-enabled clinical trial solutions by picking up digital GcP training and collaboration platform Trifecta, including its communications platform known as InvestigatorSpace® to facilitate and support virtual training programs and safety documentation services. WCG is in a race against other vendors, most notably Advarra, which just acquired a Trifecta nascent competitor called Longboat. In a tit for tat, both WCG and Advarra increasingly offer end-to-end clinical trials services and technology placing them directly in competition with major “eClinical” vendors such as VeevaMedidata (Dassault) and Oracle, not to mention contract research organization (CRO) platforms, among others to support sponsors (biotech, pharma) as the entire clinical research enterprise moves to a more permanent and serious digital reality. Industry sponsors that do a superior job, digitally, of seamlessly connecting trial site organizations, sponsors and CROs, as well as patients, across the clinical trials ecosystem will reap enormous economic benefit in the years to come. As mentioned, this latest acquisition is actually part of an intense industry competitive tit for tat between two the archrivals: WCG and Advarra. This latest acquisition follows the November Advarra and Longboat deal. In that case, Irish serial entrepreneur Gerard Ryan, who founded one of the leading GcP training portals called Firecrest—sold to Irish CRO ICON for about 50 million euros back in 2011—went at it again working to develop an even better, more modern training-focused system. Why the focus on training and collaboration? Because clinical trials sponsors face constant, expensive, and time-consuming problems associated with protocol deviations and informed consent mishaps. Once Advarra picked up Longboat, WCG made its move to counter with the acquisition of Trifecta. What’s a sponsor/buyer to do in this wild and complex competitive matrix? Do they move to the consolidator (all in one) or do they move toward best-of-breed with a demand for interoperability? And what if the entire notion for how a clinical trial is to be conducted in the first place transforms?

WCG Moves into Important but Challenging Space

WCG and Advarra are particularly interesting vendors as they come out of the institutional review board (IRB) space and, consequently, are contracted early on, as central IRBs, to help support clinical trials. Backed by private equity groups, WCG (WIRB-Copernicus Group) employs over 2,000 professionals and counts approximately 3,000 institutional and academic medical center partners. With the Trifecta acquisition, WCG intends to go after a tricky but critically important marketplace that is categorized differently, depending on the point of view and objectives. Known by some traditionally as the “investigator portal” space, this market was shaken to its core when in 2012 a powerful consortium of large pharmaceutical companies formed TransCelerate Biopharma. Partnering with a systems integration consulting firm Cognizant, the industry consortium designed their own investigator portal called Shared Investigator Platform or SIP. Although the true success of this platform is in question due to profound market place shifts since its initial design, vendors continue their march toward product enhancement and acquisition to capture more sponsor and CRO revenue. WCG’s pick up of Trifecta is just the latest example. Moving forward, Trifecta will be known as WCG Trifecta.

What does this Space do?

Now picking up Trifecta, WCG offers yet another investigator portal-based solution  to support robust GcP training, site communication, safety letter distribution and essential document exchange. WCG made another bet on this space with a similar platform back in 2014 with the purchase of e-pharmasolutions. Presently, WCG doubles down as they not only face direct harsh competition from Advarra but also face dangerous market players such as Veeva, known for a take-no-prisoners approach to leveraging cloud technology-based applications to capture this critical research collaboration space. To put matters in perspective, Veeva now commands a market capitalization of $41.1 billion.

Executive Comments

WCG Executive Chairman and CEO Donald A. Deieso, PhD, shared his thoughts on the acquisition: “With a host of services that fully integrate clinical trial training and communication, from safety letter notification to regulatory document exchange, Trifecta adds another dimension to WCG compelling value proposition.” Dr. Deieso continued, “This acquisition is part of our effort to pursue strategic opportunities that allow us to expand and enhance our offerings in anticipation of our customers’ needs. We’re pleased to be joining forces with an innovative company such as Trifecta and working together to help sponsors, CROs and clinical research sites increases efficiency and the quality of the work they do every day.”

WCG: What have they Acquired Thus Far?

TrialSite breaks down a sampling of WCG acquisitions thus far for the benefit of the TrialSite Network (audience) interested in these matters. TrialSite is committed to transparent and accessible clinical research with the ultimate aim of advancing biomedical research to better human health. Hence the more information is available about research (including the vendors that support this important activity), the better.

WCG segments its software/services by three (3) categories, including 1) Ethical Review, 2) Study Planning & Site Optimization, and 3) Patient Engagement.  

Ethical Review

Ethical Review represents WCG’s roots and of course a critically important service.  Included in this national leading (along with Advarra) consolidated suite of services includes WCG IRB and IRBNet. According to their website, WCG IRB is the first independent IRB to receive AAHRPP accreditation and the only IRB to hold ISO certification. This foundational unit of WCG touts accelerated value-add, such as rapid review for new sites during study start up.

IRBNet, an electronic communication portal platform between sites and IRB, was part of an Arsenal Capital-led purchase back in 2012

Study Planning & Site Optimization

Study Planning & Site Optimization involves a number of relatively small to moderately sized acquisitions.  e-pharmasolutions was one of the first investigator portal platforms or products on the market. One of TrialSite’s founders, Daniel O’Connor, actually founded another venture that competed head on against that firm. e-pharmasolutions’ founder Lance Converse (now a managing partner with Crosstree Equity Fund), had deep ties into the world of patient recruitment and clinical trials and was involved with the launch of Acurian, one of the first online patient recruitment platforms.

Leading CRO PPD bought this online platform. Although e-pharmasolutions’ vision was far reaching, actual execution was limited to a handful of pharma companies and some believed the technology components were fragmented. They faced severe competition from Veeva on the one side, and TransCelerate SIP on the other, and hence made the rational move to team up with a far bigger WCG. It should be noted that CrossTree, a boutique Florida-based investment bank, served as financial advisor and takes on a more prominent role with Mr. Converse taking a role there.

In 2018, WCG picked up KMR Group and Metrics Champion Consortium, two vendors in benchmarking metrics, analytics and performance management in the clinical research and development space. These purchases bolstered WCG’s Market Insights and Intelligence Division that already included acquisitions such as CenterWatch and FDAnews.

Now for study planning and site optimization purchases, WCG could sell services associated with trusted benchmarking, databases, market intelligence reports, newsletters, webinars and conferences (the latter can be lucrative not only in terms of profit but also for securing brand mindset).

Adding hands-on patient recruitment services became instrumental to capture additional revenue opportunity, hence in 2019 WCG acquired PharmaSeek LLC including its wholly-owned subsidiaries PFS Clinical and PatientWise, vendors involved with  “turn-key” services offered to trial site organizations, from administration and consulting to patient recruitment and training. PharmaSeek had been around for over a quarter century already but the consolidation forces in life sciences led to the need for teaming with a far bigger player.

WCG moved deeper into the nuts and bolts of site management with the acquisition of Velos in Jan. 2019. By buying Velos, WCG now possessed one of the leading clinical trial management systems used by major academic medical centers for example. Months later in the same tit for tat race, Advarra purchased Velos’ leading competitor Forte in a clear war among the two leading private equity-backed, IRB consolidators: that is WCG and Advarra.

Patient Engagement

Patient Engagement, of course, represents a huge trend given the general move to digital prior to COVID-19, and the new reality now where expectations have radically shifted toward acceleration of patient-centric studies. Although this concept and supporting technologies have been around for many years, the rubber now hits the road for decentralized clinical trials in the COVID-19 era. 

Hence a number of assets picked up by WCG are positioned as relevant depending on the situation and needs. Various solutions picked up over the years include MedAvante-ProPhase, an acquisition in May 2017 opening a bigger door to the growing central nervous system (CNS) and behavioral health assessment markets via delivery of software tools and solutions that purportedly improved signal detection.

Also in 2017, WCG picked up TheraWire (patient enrollment and retention solutions) and by August 2017 the consolidator acquired ConsentNow from Genesis. WCG sought out this tool to sell to pharmaceutical and medical device sponsors a digital platform enabling the use of custom video and animation to educate and even test patients for purposes of richer, more engaging informed consent. 

Finally in 2019 WCG acquired Analgesic Solutions (tools for pain management solutions) while also offering their iConnect tool, purportedly a leading software tool to track patient recruitment and enrollment metrics.

Competitive Milieu

Although the forces for consolidation will continue as WCG, Advarra, Veeva, Medidata, Oracle and others go head to head to help industry sponsors digitize clinical trials, of course the CROs in many cases also bring their own internally developed solutions or in some cases they contract out with vendors to offer bundled options. 

New disruptive upstarts such as Medable seek to shake the market up even further as patient-centric, digital-only or hybrid studies become the norm. The clinical trials buying landscape while in some ways becomes more rationalized and consolidated, in other ways becomes more complex as disruptive transformation creates a whole new class of emerging business models such as the nascent clinical research as a care movement. Firms such as Javara, an integrated research organization led by the highly respected and knowledgeable Jennifer Byrne, a site-centric professional executing on an ambitious agenda enabling and empowering health systems and medical centers as drivers of research; or Elligo Health Research, offering bundled “research as a care option” services to clinics to federated data-driven plays such as TriNetX, recently acquired, at least in part, by the prestigious and powerful investment group known as the Carlyle Group. The latter made the investment to capitalize on TriNetX’s growing client base, a graph matrix of connection points between health care systems and academic medical centers and their patient records and sponsors and their CROs.  

Sponsors that educate themselves and keep their finger on the pulsebeat of change, all things being equal, will benefit from understanding this complex, dynamic and unfolding vendor landscape.

About WCG

WCG positions itself as the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprising two divisions, the industry’s first central IRB – WCG IRB – and first clinical services organization, WCG enables biopharmaceutical companies, CROs, and institutions to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection. They face competition with Advarra and depending on the business area compete with Veeva, Oracle, Medidata (Dassault) and even CROs.

About Trifecta

Trifecta is a global leader and a trusted partner with decades of experience in clinical trial technology solutions for leading pharmaceutical, biotech and clinical research organizations. From accelerating study start up for trials of all sizes to organizing and distributing critical training and safety event information, to facilitating essential document exchange, Trifecta offers a fully integrated training, safety and communication platform built from the ground up. Through it, Trifecta positions that its tools can help increase the speed of clinical trials without compromising accuracy. Trifecta by itself faced increasing competition whether it was on the GcP training side or in head on competition selling clinical trial document exchange and collaboration tools. Competitors again included TransCelerate SIP, Veeva, ICON (Firecrest), Longboat (now Advarra) and others. That competition leads to consolidation.

Call to Action: Interested in better understanding this space? Feel free to reach out to TrialSite directly. TrialSite can share with sponsors that it’s critically important to understand specific requirements. Many software projects fail not because of actual software code but due to faulty product requirement elicitation processes.