Posted by Kinapse on 27 June 2016
PHILADELPHIA – DIA 2016 Annual Meeting – June 27, 2016 – Today at the Drug Information Association’s (DIA) Annual Meeting,Veeva Systems (NYSE: VEEV) and Kinapse Ltd., a leading provider of life sciences advisory and operational services, announced that Kinapse has selected Veeva Vault Submissions to power its new regulatory operational services. Veeva Vault Submissions provides Kinapse a modern cloud application for authoring and managing regulatory submissions content. Kinapse will now offer sponsors the option to produce regulatory deliverables on Vault Submissions and leverage Kinapse’s new efficient processes that have been optimized on Veeva’s cloud platform.
“Service providers play an increasing role in regulatory operations today,” said Katrin Spaepen, director of Vault RIM Strategy at Veeva Systems. “Veeva Vault Submissions will provide Kinapse customers a shared authoritative source for submissions content. Combined with Kinapse’s services, sponsors can achieve global accessibility and real-time visibility into their regulatory submissions processes.”
Today there are two ways sponsors work with regulatory submissions service providers. Sponsors have service providers access their on-premise systems remotely, slowing performance and limiting innovation by constraining the service provider to follow the sponsor’s model of operation. Alternatively, sponsors author, review, and approve submission documents within their own systems then manually transmit documents to submission partners. This makes document changes difficult to track, creating inefficiencies and increasing risk.
“Veeva Vault Submissions changes how sponsors and their partners collaborate by providing fast, direct access to manage content and data,” said Marc Gabriel, client partner at Kinapse. “Veeva Vault ensures submissions are managed with greater quality, efficiency, and control by allowing the sponsor and service provider to access their documents and data through the cloud and view status in real-time.”
Kinapse is coupling Vault Submissions with a new set of streamlined regulatory processes that take advantage of Veeva’s advanced capabilities for regulated document management. Kinapse rigorously tested the platform’s key functions, including the segmentation of client data. The Kinapse regulatory team is trained and ready to deliver submissions on the Vault platform.
“There is significant interest around Veeva’s unique cloud applications for regulatory information management (RIM),” said Aileen Fisher, vice president of Regulatory Affairs and Pharmacovigilance Services for Kinapse. “With Veeva Vault Submissions, we expect our customers to benefit from greater access, visibility, and control over their submissions information and, ultimately, speed their time to submission.”
Kinapse provides the biopharmaceutical industry with services across the product lifecycle, including submission management, strategy, publishing, CMC authoring, labeling, intelligence, safety reports, and full pre- and post-submission support.
For more on Veeva Vault Submissions, visit: veeva.com/VaultSubmissionsStay updated on the latest Veeva news on LinkedIn: linkedin.com/company/veeva-systemsFollow @veevasystems on Twitter: twitter.com/veevasystems Like Veeva on Facebook: facebook.com/veevasystemsFor more on Kinapse regulatory services, visit: kinapse.com/our-expertise/our-services/regulatory-affairs/ Stay updated on the latest Kinapse news on LinkedIn: linkedin.com/company/kinapse
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 400 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 veeva.com.
About Kinapse Kinapse provides expert advisory, capability building and operational services to the world’s leading life sciences organizations, their customers, suppliers and regulators. Their clients include many of the world’s leading pharmaceutical companies, their customers, suppliers and regulators. Kinapse uses a novel operating and delivery model that allows them to bring together the very best people in virtual teams, in a wide range of R&D domains, committed to the success of our clients. Headquartered in London, Kinapse currently employs over 600 people in the U.K., U.S. and India. For more information, please visit http://www.kinapse.com/.
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-Q for the period ended April 30, 2016. 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.
Veeva Systems; Roger Villareal
Kinapse; Lucy Ackah
Advise · Build · Operate