SYS-CON MEDIA Authors: Zakia Bouachraoui, Elizabeth White, Liz McMillan, William Schmarzo, Dana Gardner

News Feed Item

Debiopharm International SA Strengthens Compliance and Clinical Trial Oversight with Veeva Vault eTMF

Veeva Systems (NYSE: VEEV) announced today that Debiopharm International SA, part of Swiss-based biopharmaceutical company Debiopharm Group™, selected Veeva Vault eTMF to improve oversight across its trial master file (TMF) processes and work closely with contract research organizations (CROs) by collaborating on a single, cloud-based application.

“Veeva is helping us streamline our clinical operations,” said Christian A. Aeschlimann, director of clinical operations at Debiopharm. “Veeva Vault eTMF will help us maintain an always-accurate, up-to-date TMF and align with external partners by working in the same system.”

As a sponsor, Debiopharm is required by ICH E6(R2) to maintain oversight throughout clinical trials. External partners were unable to access the company's previous, on-premise eTMF, so CROs used their own systems and transferred documents periodically. This meant that Debiopharm did not have full, real-time visibility into the CROs’ TMF activities.

Veeva Vault eTMF provides a single source of truth for trial documentation. Sponsors and CROs can manage TMF documents and processes in the same system, in real-time, as they are being executed. Now Debiopharm can keep its TMF in a constant state of inspection readiness and ensure partners adhere to its standard operating procedures.

“In our quest for continuous improvement, we selected Veeva Vault eTMF to help us work more efficiently and maintain high quality trial documentation,” said Vincent Demeautis, clinical operations manager at Debiopharm. “Sharing a single system with CROs to drive all TMF processes will eliminate the need to manage and reconcile multiple TMF sources while improving our responsiveness and collaboration with external and internal study team members.”

Veeva Vault eTMF will also provide Debiopharm with reports and dashboards for visibility into TMF completeness, timeliness, and accuracy. This will help the company to check the status and quality of documentation and proactively resolve any issues that arise.

"Veeva Vault eTMF was the best solution on the market to meet our current and future needs," said Sofie Lemmens, senior clinical trial associate at Debiopharm, who led the implementation of Veeva Vault eTMF. "It was a critical investment across our internal teams to improve TMF quality and access."

By adopting Veeva Vault eTMF, Debiopharm has taken its first step toward a unified clinical model to streamline end-to-end processes and systems, increase collaboration, and improve performance across trials. This reflects an industrywide shift, with nearly all (99%) respondents to the Veeva 2017 Unified Clinical Operations Survey reporting the need to unify their clinical operations.

“Sponsors are unifying systems and processes to improve study quality and execution while managing a growing number of trials and increasing complexity across the clinical lifecycle,” said Rik Van Mol, vice president, R&D Strategy, Europe at Veeva. “Veeva Vault eTMF lets Debiopharm improve trial visibility and compliance as well as begin a journey toward unified clinical operations.”

Veeva Vault eTMF is part of Veeva Vault Clinical Suite, the industry's first suite of applications that combines eTMF with EDC, CTMS, and study start-up to unify clinical data management and operations. To learn how organizations are eliminating system silos across clinical operations with Veeva Vault Clinical Suite, visit veeva.com/eu/Clinical.

Additional Information

For more on Veeva Vault eTMF, visit: veeva.com/eu/eTMF

Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems

Follow @Veeva_EU on Twitter: twitter.com/veeva_eu

Like Veeva on Facebook: facebook.com/veevasystems

About Veeva Systems

Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 600 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit www.veeva.com/eu.

About Debiopharm International SA

Part of Debiopharm Group™ – a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management – Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide. For more information, please visit debiopharm.com or follow @DebiopharmNews on Twitter.

Forward-looking Statements

This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the company’s filing on Form 10-K for the period ended January 31, 2018. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

###

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Organize your corporate travel faster, at lower cost. Hotailors is a next-gen AI-powered travel platform. What is Hotailors? Hotailors is a platform for organising business travels that grants access to the best real-time offers from 2.000.000+ hotels and 700+ airlines in the whole world. Thanks to our solution you can plan, book & expense business trips in less than 5 minutes. Accordingly to your travel policy, budget limits and cashless for your employees. With our reporting, int...
DXWorldEXPO LLC announced today that the upcoming DXWorldEXPO | DevOpsSUMMIT | CloudEXPO New York will feature 10 companies from Poland to participate at the "Poland Digital Transformation Pavilion" on November 12-13, 2018. Polish Digital Transformation companies which will exhibit at CloudEXPO | DevOpsSUMMIT | DXWorldEXPO include All in Mobile, dhosting, Cryptomage, Perfect Gym, Polcom, Apius Technologies, Aplisens, ELZAB SA, TELDAT, and Rebug.io.
Enterprises are universally struggling to understand where the new tools and methodologies of DevOps fit into their organizations, and are universally making the same mistakes. These mistakes are not unavoidable, and in fact, avoiding them gifts an organization with sustained competitive advantage, just like it did for Japanese Manufacturing Post WWII.
Whenever a new technology hits the high points of hype, everyone starts talking about it like it will solve all their business problems. Blockchain is one of those technologies. According to Gartner's latest report on the hype cycle of emerging technologies, blockchain has just passed the peak of their hype cycle curve. If you read the news articles about it, one would think it has taken over the technology world. No disruptive technology is without its challenges and potential impediments t...
There's no doubt that blockchain technology is a powerful tool for the enterprise, but bringing it mainstream has not been without challenges. As VP of Technology at 8base, Andrei is working to make developing a blockchain application accessible to anyone. With better tools, entrepreneurs and developers can work together to quickly and effectively launch applications that integrate smart contracts and blockchain technology. This will ultimately accelerate blockchain adoption on a global scale.
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, described how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launching o...
DXWorldEXPO LLC announced today that Nutanix has been named "Platinum Sponsor" of CloudEXPO | DevOpsSUMMIT | DXWorldEXPO New York, which will take place November 12-13, 2018 in New York City. Nutanix makes infrastructure invisible, elevating IT to focus on the applications and services that power their business. The Nutanix Enterprise Cloud Platform blends web-scale engineering and consumer-grade design to natively converge server, storage, virtualization and networking into a resilient, softwar...
Despite being the market leader, we recognized the need to transform and reinvent our business at Dynatrace, before someone else disrupted the market. Over the course of three years, we changed everything - our technology, our culture and our brand image. In this session we'll discuss how we navigated through our own innovator's dilemma, and share takeaways from our experience that you can apply to your own organization.
Founded in 2002 and headquartered in Chicago, Nexum® takes a comprehensive approach to security. Nexum approaches business with one simple statement: “Do what’s right for the customer and success will follow.” Nexum helps you mitigate risks, protect your data, increase business continuity and meet your unique business objectives by: Detecting and preventing network threats, intrusions and disruptions Equipping you with the information, tools, training and resources you need to effectively m...
The Transparent Cloud-computing Consortium (T-Cloud) is a neutral organization for researching new computing models and business opportunities in IoT era. In his session, Ikuo Nakagawa, Co-Founder and Board Member at Transparent Cloud Computing Consortium, will introduce the big change toward the "connected-economy" in the digital age. He'll introduce and describe some leading-edge business cases from his original points of view, and discuss models & strategies in the connected-economy. Nowad...
Having been in the web hosting industry since 2002, dhosting has gained a great deal of experience while working on a wide range of projects. This experience has enabled the company to develop our amazing new product, which they are now excited to present! Among dHosting's greatest achievements, they can include the development of their own hosting panel, the building of their fully redundant server system, and the creation of dhHosting's unique product, Dynamic Edge.
Intel is an American multinational corporation and technology company headquartered in Santa Clara, California, in the Silicon Valley. It is the world's second largest and second highest valued semiconductor chip maker based on revenue after being overtaken by Samsung, and is the inventor of the x86 series of microprocessors, the processors found in most personal computers (PCs). Intel supplies processors for computer system manufacturers such as Apple, Lenovo, HP, and Dell. Intel also manufactu...
Doug was appointed CEO of Big Switch in 2013 to lead the company on its mission to provide modern cloud and data center networking solutions capable of disrupting the stronghold by legacy vendors. Under his guidance, Big Switch has experienced 30+% average QoQ growth for the last 16 quarters; more than quadrupled headcount; successfully shifted to a software-only and subscription-based recurring revenue model; solidified key partnerships with Accton/Edgecore, Dell EMC, HPE, Nutanix, RedHat and V...
PCCW Global is a leading telecommunications provider, offering the latest voice and data solutions to multi-national enterprises and communication service providers. Our truly global coverage combined with local, on the ground knowledge has helped us build best in class connections across the globe; and especially in some of the remotest, hard-to-reach areas in exciting growth markets across Asia, Africa, Latin America and the Middle East.
NanoVMs is the only production ready unikernel infrastructure solution on the market today. Unikernels prevent server intrusions by isolating applications to one virtual machine with no users, no shells and no way to run other programs on them. Unikernels run faster and are lighter than even docker containers.