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BARCELONA, Spain, October 23, 2014 /PRNewswire/ –
Clients benefit from complete access, visibility, and control throughout the clinical trial
inVentiv Health Clinical, a leading global supplier of drug development services, will replace its electronic trial master file (eTMF) content management system with Veeva Vault eTMF. Cloud-based, multitenant Vault eTMF delivers secure, instant access to inspection-ready documentation and enables seamless collaboration between inVentiv, trial sponsors, and trial sites worldwide – ultimately helping to speed time to submission and product approval.
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“With Vault eTMF, we believe we can provide sponsors with transparency of trial data and enable a richer, more collaborative partnership for improved trial results, including faster time to market,” said Gregg Dearhammer, chief operating officer at inVentiv Health Clinical. “It’s another example of inVentiv delivering innovative global solutions intended to support the development and commercial objectives of our clients.”
Vault eTMF is preconfigured with the Drug Information Association (DIA) TMF Reference Model for a repeatable framework across the enterprise. It supports inspection-readiness with workflow, reports, and dashboards, plus features robust audit trails and an auditor role that supports remote inspection capabilities for sponsors and health authorities.
“Vault eTMF should simplify the entire drug development process, minimising duplication and improving collaboration, not only across our own teams but with our clients,” explained Rachel Stahler, chief information officer at inVentiv Health Clinical. “And the cloud-based solution should allow us to provide more efficient contract services to our customers in a rapidly changing landscape.”
Vault eTMF also enables shared visibility for participants so that the most current status of trial-related documentation is available at any time. Additionally, Vault Investigator Portal makes collaboration with site personnel easy for faster study start-up and more efficient operations overall.
“We are proud to support inVentiv in its drive to provide customers with a highly differentiated service that spans from the clinical phase through commercialisation,” concluded Jennifer Goldsmith, vice president of Veeva Vault. “Today, we join forces to break down the walls that hinder strategic collaboration between CROs, sponsors, and trial sites worldwide.”
Vault eTMF and Vault Investigator Portal are part of Veeva Vault, a cloud-based platform and suite of integrated content management applications for the life sciences industry. Vault spans clinical, quality, commercial, and medical – every major part of a life sciences company – giving pharmaceutical, biotechnology, and medical device companies the ability to deploy a single content management system globally.
Helping companies connect securely in the life sciences cloud, Vault provides complete control from start to finish, as well as the easy accessibility, visibility, and agility needed to speed time to market. Vault offers real-time reporting and dashboards; an intuitive, consumer-web interface; and a true multitenant cloud architecture that continuously delivers rapid innovation. Today, more than 100 customers rely upon Veeva Vault to manage some of their most important content. Over the past year alone, Veeva Systems has seen a threefold increase in the number of Vaults utilised by Veeva customers.
• For more information on Veeva Vault eTMF, please visit http://www.veeva.com/rd-content-management/vault-etmf/
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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 200 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 http://www.veeva.com.
About inVentiv Health Clinical
inVentiv Health Clinical is a next generation CRO. We take a patient-centric approach and apply smarter, fresher thinking to go well beyond traditional outsourced services. We are a leading provider of global drug development services to the biopharmaceutical industry, offering therapeutically specialised capabilities for phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team. As part of inVentiv Health, we can both develop and fully commercialise products for the life sciences industry. Learn more about how we support the entire product lifecycle http://www.inventivhealthclinical.com.
This release contains forward-looking statements, including statements regarding benefits from the use of Veeva’s solutions and general business conditions. 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-Q for the period ended July 31, 2014, which is available on the company’s website at http://www.veeva.com under the Investors section and on the SEC’s website at http://www.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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks that may cause our performance to differ materially. These forward-looking statements reflect our current views about future events and are subject to risks, uncertainties and assumptions. We wish to caution readers that certain important factors may have affected and could in the future affect our actual results and could cause actual results to differ significantly from those expressed in any forward-looking statement. Such factors include, without limitation: the impact of our substantial level of indebtedness on our ability to generate sufficient cash to fulfil our obligations under our existing debt instruments or our ability to incur additional indebtedness; the impact of customer project delays, cancellations and terminations and our ability to sufficiently increase our revenues and manage expenses and capital expenditures to permit us to fund our operations; the impact of the consummation of our acquisition of Catalina Health Resource, LLC and any future acquisitions; the impact of any change in our current credit ratings and the ratings of our debt securities on our relationships with customers, vendors and other third parties; the impact of any additional leverage we may incur on our ratings and the ratings of our debt securities; our ability to continue to comply with the covenants and terms of our senior secured credit facilities and to access sufficient capital under our credit agreement or from other sources of debt or equity financing to fund our operations; the impact of any default by any of our credit providers; our ability to accurately forecast costs to be incurred in providing services under fixed price contracts; our ability to accurately forecast insurance claims within our self- insured programs; the potential impact on pharmaceutical manufacturers, including pricing pressures, from healthcare reform initiatives or from changes in the reimbursement policies of third-party payers; our ability to grow our existing client relationships, obtain new clients and cross-sell our services; the potential impact of financial, economic, political and other risks, including interest rate and exchange rate risks, related to conducting business internationally; our ability to successfully operate new lines of business; our ability to manage our infrastructure and resources to support our growth, including through outsourced service providers; our ability to successfully identify new businesses to acquire, conclude acquisition negotiations and integrate the acquired businesses into our operation, and achieve the resulting synergies; any disruptions, impairments, or malfunctions affecting software as well as excessive costs or delays that may adversely impact our continued investment in and development of software; the potential impact of government regulation on us and on our clients, including the impact of the final HIPAA Privacy Rule on the willingness of pharmaceutical manufacturers to sponsor patient adherence programs; our ability to comply with all applicable laws as well as our ability to successfully adapt to any changes in applicable laws on a timely and cost effective basis; our ability to recruit, motivate and retain qualified personnel; any potential impairment of goodwill or intangible assets and the factors leading to such impairments; consolidation in the pharmaceutical industry; changes in trends in the healthcare and pharmaceutical industries or in pharmaceutical outsourcing, including initiatives by our clients to perform services we offer internally; our ability to convert backlog into revenue; the potential liability associated with injury to clinical trial participants; the impact of the adoption of certain accounting standards; and our ability to maintain technological advantages in a variety of functional areas, including sales force automation, electronic claims surveillance and patient compliance. Holders of our debt instruments are referred to reports provided to investors from time to time and the offering memoranda provided in connection with the issuance of our notes for further discussion of these risks and other factors.
Sue Glanville / Cate Bonthuys
Veeva Systems Inc.
[email protected] / [email protected]
inVentiv Health Clinical
SOURCE Veeva Systems