CRO implements paperless processes for regulatory development activities across the enterprise
PLEASANTON, CA – Jan. 28, 2015 – The largest contract research organization (CRO) in Japan, CMIC Holdings, is transitioning from paper to electronic processes with Veeva Vault QualityDocs, the life sciences cloud-based regulated content management solution from Veeva Systems. CMIC plans to leverage Vault QualityDocs across its enterprise for all standard operating procedure (SOP) document creation, management, and reporting. The switch to an electronic system will not only improve efficiency, but it will also provide management with assured compliance to customers. With Vault QualityDocs, CMIC now has a single, authoritative source for verified, current quality documents.
In recent years across Japan, many SOP creation and management processes have been targeted for regulatory audits. To ensure compliance, CMIC has established a total management process – from establishment and documentation of operation standards to in-house training processes – with Veeva Vault QualityDocs as its technology foundation. The company noted Vault’s remarkably fast implementation, going live across all 50 users in less than four weeks. CMIC also reports significantly improved document creation efficiency and higher overall quality of operations.
CMIC is growing its global business, increasing the number of contracted clinical trials it manages dramatically in the last few years. To maintain efficiency and compliance amidst rapid growth, the company searched for a new content management system – ideally built on multitenant cloud architecture. Vault QualityDocs met CMIC’s criteria for a best-of-breed solution and is now increasing control and efficiency throughout several locations, including its Japan headquarters.
“Vault is strengthening our compliance and streamlining document management across the enterprise,” said Nobuo Nakamura, CRO company president of CMIC. As CMIC continues to expand globally, Veeva will remain an important technology partner with solutions that scale easily to meet our growing needs.”
Vault QualityDocs provides CMIC with a single source of all quality system documents, manufacturing records, development reports, and validation documents across the enterprise. An approved document is uploaded once and shared to all globally – eliminating the risk and inefficiency of unsecured paper copies. In addition, Vault QualityDocs’ Read and Understood functionality allows team members to review documents easily and management to monitor completion using simple dashboards.
About Veeva Vault
Veeva Vault is the first cloud-based regulated content management platform and suite of applications designed for life sciences. It spans clinical, quality, commercial, medical, and every major part of a global life sciences company to ensure one trusted source for content and data across the enterprise. 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. All Vault applications offer 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 Vault to manage critical content and the number of Vaults has grown threefold in just one year.
- For more information on Veeva Vault, please visit: www.veeva.com/vault/
- Stay updated on the latest Veeva news on LinkedIn: www.linkedin.com/company/veeva-systems
- Follow @veevasystems on Twitter: www.twitter.com/veevasystems
- Like Veeva on Facebook: www.facebook.com/
About CMIC HOLDINGS CO., Ltd.
Since its establishment in 1992, CMIC has been a leading CRO (Contract Research Organization) in Tokyo, Japan and has expanded its geographical coverage within Asia, including China, Taiwan, Singapore, Korea and Malaysia, the most rapidly growing market in the world. CMIC has global/Asian clinical trial hands-on experience and expertise and can provide clients with the value-added services to support Phase I-IV clinical trials in various therapeutic areas. In addition to monitoring, DM/STAT and project management services, CMIC offers strategic and regulatory affairs consultation that requires strong networking skills with the regulatory authorities, as well as extensive knowledge of regulatory requirements. Our scope of services encompasses such business functions as Contract Manufacturing Organization (CMO), Contract Sales Organization (CSO) and Site Management Organization (SMO). For more details, visit http://www.cmic-holdings.co.jp/e/.
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 www.veeva.com.
This release contains forward-looking statements, including statements regarding benefits from the use of Veeva’s solutions, demand for 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 October 31, 2014, which is available on the company’s website at www.veeva.com under the Investors section and on the SEC’s website at 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.
Veeva Systems Inc.