More companies are unifying their global data, content, and processes across clinical operations with Veeva Vault CTMS. In less than a year, the number of Vault CTMS customers has doubled to 50, signaling the industry’s continued shift in adopting the advanced cloud application from Veeva Systems to improve trial performance.
“CTMS is a highly complex area that has been held back for decades by a lack of innovation,” said Henry Galio, senior director for Veeva Vault CTMS. “Veeva Vault CTMS is meeting the industry’s significant need for a modern solution to streamline operations and conduct trials more efficiently and effectively.”
Vault CTMS provides organizations one complete source of trial information to make faster and smarter decisions throughout the course of a study. “Our prior CTMS was difficult to configure and use,” said Eric Hanson, IT Manager at SCRI. “Veeva Vault CTMS is a modern system that is easily configurable with advanced functionality, enabling us to increase study team engagement and improve report timeliness, all while eliminating manual processes.”
On August 28, 2019, Veeva Systems announced new capabilities in Veeva Vault RIM for medical devices and diagnostics to manage regulatory documents and processes. Organizations can unify product registrations, health authority correspondence and commitments, and submissions documents on a single cloud platform for one global authoritative source of regulatory information.
Regulatory requirements are rapidly changing, especially with the European MDR going into effect in 2020. Regulatory activities are largely manual, making it difficult to manage the complexity of global submission dossiers and ensure consistency across the end-to-end process.
“Device and diagnostics companies face greater regulatory scrutiny and complexity than ever before,” said Michael Morton, RAC, member of Regulatory Affairs Professional Society (RAPS) board of directors and former vice president of corporate regulatory affairs at Medtronic. “Traditional, manual approaches no longer work. If companies don’t change their model and upgrade to modern technologies, they will struggle to stay compliant and delay getting their products to market.”
Vault RIM now includes new medical device capabilities to streamline processes and drive greater efficiency. Medical device product registration data is modeled to conform with US and EU UDI guidelines. Vault RIM has also expanded to support industry-standard submissions formats such as STED, IMDRF, and 510(k) to improve collaboration and execution across global stakeholders.
Vault RIM applications in the Veeva Vault Medical Device Suite include Vault Registrations for simplified planning, tracking, and reporting on product registrations and health authority correspondence; Vault Submissions for easier authoring and submissions assembly; and Vault Submissions Archive for global access to a complete history of submissions.
Several medical device companies, including a top 20, are among the early customers adopting Vault Medical Device RIM applications to eliminate manual handoffs and fragmented processes globally. Veeva’s entry into RIM for the medical device market builds upon the company’s success in regulatory. More than 180 biopharmaceutical companies use Vault RIM applications for efficient submissions development and greater visibility across end-to-end regulatory processes.
“The addition of RIM to the Veeva Vault Medical Device Suite gives manufacturers tailored applications to manage evolving regulatory requirements and increase collaboration globally,” said Annemien Pullen, director of strategy for medical device and diagnostics at Veeva Europe. “Our regulatory applications allow companies to get ahead of these changes and bring their products to market faster.”
The Veeva Vault Medical Device Suite includes commercial, clinical, quality, and regulatory applications to provide manufacturers with greater visibility, collaboration, and speed across the product development lifecycle. More than 70 medical device and diagnostics companies, including 8 of the 10 largest, are now using Vault Medical Device Suite applications.
Earlier this month, Veeva announced that Alcon, a global medical device company specializing in surgical and vision care products, chose Veeva Vault Clinical Data Management System (CDMS) as its enterprise clinical data management system for electronic data capture (EDC).
This video explains more about what Veeva offers:
On August 28, 2019, Keybanc analyst Brent Bracelin raised his price target for Veeva to $190 from $172, citing “impressive” July results as growth accelerated to 27% year over year, even while crossing the $1B revenue run-rate milestone. The analyst sees a “compelling opportunity” for Veeva to double revenue again as it capitalizes on modern cloud software within the core life sciences vertical, as well as beyond. Bracelin reiterates an Overweight rating on the shares.
Also on August 28, 2019, DA Davidson analyst Rishi Jaluria raised his price target on Veeva to $200 and kept his Buy rating after its “strong” beat and raise quarter, saying the company generated its highest subscription growth in eight quarters with record operating margins of 38.9%. The analyst cites “standout” performance in Veeva’s CRM Engage as it doubled its customer count, adding that its Vault CDMS also picked up its first top-20 medical device customer. Jaluria notes that the stock remains his top pick among SaaS companies based on its domain expertise along with its “leading balance of growth and profitability.”
Another upgrade came on August 28, 2019, from Needham analyst Scott Berg who raised his price target on Veeva to $187 and kept his Buy rating after a “strong” quarter of results in Q2 with billings growth of 28.5%. The analyst also cites the management’s increased Commercial Cloud growth outlook to 13%-14% from 11% thanks to the “strong performance” from the company’s new add-on modules, including Nitro, Andi and Engage. Berg further believes that the company’s product pipeline and “efficient” financial model can sustain the 25% or more subscription revenue growth rate in the back half of FY20.
Also on August 28, 2019, Guggenheim analyst Ken Wong raised his price target for Veeva Systems to $180 from $154 saying he expects investors to react favorably to the company’s Q2 results. The analyst sees “strong” fundamentals with billings, revenue, and margins all exceeding consensus expectations. Vault momentum still delivering upside, says Wong, who keeps a Buy rating on Veeva.
Also on August 28, 2019, SunTrust analyst Sandy Draper raised his price target on Veeva to $180 and kept his Buy rating after its beat-and-raise Q2 results. The analyst believes that the company’s first-half of FY20 was highlighted by the “strong momentum” in its Commercial segment as broader adoption of its product suite helped accelerate the unit’s revenue growth. Draper further cites the market share gaining potential of Vault CDMS and the “recent success” of Veeva’s ex-Life sciences solutions.
Finally, on August 28, 2019, Stephens analyst James Rutherford raised his price target for Veeva Systems to $185 from $155 following the company’s Q2 results. Vault continues to drive Veeva forward as new and existing customers replace legacy patchwork systems with Veeva’s modern, unified cloud applications, Rutherford tells investors in a research note. The analyst expects Veeva to manage through its CFO transition well and keeps an Overweight rating on the shares.
An increasing number of contract research organizations (CROs) are adopting Veeva Development Cloud applications from Veeva Systems in an industrywide drive to improve efficiency, compliance, and collaboration in working with sponsors and sites. More than 55 CROs, including 6 of the top 7 global CROs, are modernizing their clinical, regulatory, and quality processes to accelerate drug development.
“We have significantly improved our trial efficiency by streamlining clinical operations with Veeva Vault eTMF,” said Julie Ross, president at Advanced Clinical. “We can now maintain an always up-to-date TMF with real-time visibility into documents and processes, allowing us to provide a better clinical experience for our clients and always remain inspection-ready.”
Veeva Development Cloud brings together suites of unified applications for clinical, regulatory, quality, and safety on a single cloud platform so CROs can eliminate silos across their ecosystem of partners. CROs are adopting applications in Vault Clinical Suite to accelerate trial execution, Vault RIM Suite to simplify regulatory submissions, and Vault Quality Suite to unify quality management for greater control and compliance.
“Veeva Vault CTMS provides us a single source of clinical master data while Veeva Vault eTMF helps us maintain a constant state of inspection-readiness,” said Vita Lanoce, CEO at Linical Accelovance. “With Veeva Development Cloud, we can drive end-to-end business processes more efficiently and deliver the high level of performance expected by our sponsors.”
“As a strategic partner to life sciences, Veeva is committed to helping CROs improve the way they work with sponsors to speed end-to-end drug development,” said Jim Reilly, vice president of Veeva Vault Clinical. “Veeva Development Cloud gives CROs a powerful platform to streamline their business processes and support the industry’s mission in getting treatments to patients faster.”
VEEV stock has been consolidating and now looks ready to continue its strong uptrend on the daily chart.
VEEV stock is too expensive for inclusion in the GST Portfolio at this time; however, I think we have a beautiful short-term swing trade setup on the chart that readers may be able to benefit from.
Disclosure: We do not hold any position in VEEV stock.