Biotech implements paperless processes for regulatory development
activities across the enterprise
PLEASANTON, Calif.--(BUSINESS WIRE)--
To improve visibility, control, and collaboration for its ongoing and
planned clinical trials, San Diego-based biotech Conatus Pharmaceuticals
selected cloud-based Veeva Vault eTMF and Veeva Vault QualityDocs –
applications for the management of clinical study and quality and
development documentation, respectively. As the company expanded its
network of external partners across a growing number of sites worldwide,
Conatus sought a fully paperless solution to reduce costs and provide an
efficient way for all parties – including a largely mobile clinical
workforce – to access content. With Veeva Vault eTMF and Veeva Vault
QualityDocs, Conatus has gained a single, authoritative source for
verified, current documents, streamlining information sharing across the
enterprise.
Conatus had been using a hybrid of paper and electronic document
management processes to support the clinical study of their
first-in-class compound, emricasan, but wanted to increase efficiency
and improve collaboration across all stakeholders globally. In addition,
Conatus wanted an advanced, industry-specific system and to free
internal staff to refocus on core competencies. With Vault’s multitenant
cloud infrastructure, Conatus will no longer be sidetracked by system
maintenance – Vault applications provide key life sciences functionality
without the need for heavy customization. In addition, because Vault
eTMF and Vault QualityDocs are delivered in the cloud, Conatus gains
automatic access to continuous innovation – eliminating lengthy, manual
system upgrade projects.
“To increase efficiency and enable our teams to focus on our core
business, we wanted to outsource our key business applications – that’s
what led us to Veeva. Easily configured to our specifications and
continually updated, Vault ensures we are always working with the latest
and most relevant technology without a large infrastructure investment
or time drain,” remarked Conatus CEO
Steve Mento
. “Our priority is
developing drugs – not managing paper or upgrading technology. Vault
helps us move faster and improve effectiveness by allowing us to
collaborate easily, maintain the control we need in a regulated
environment, and improve visibility. Real-time reporting capabilities
give us immediate insight into where content stands, so we can address
bottlenecks quickly and improve our processes on an ongoing basis.”
Since its inception, Conatus has made efficiency a guiding principle in
order to concentrate its resources on research and development. Vault
eTMF aligns with Conatus’ corporate mission by eliminating inefficient
and labor-intensive paper-based processes to simplify trial document
exchange. Early results indicate that Conatus is also in step with
recent research
that shows companies using advanced eTMF technologies experience
significant benefits such as improved collaboration,
inspection-readiness, visibility, and cost savings. And as Vault eTMF is
built according to the DIA TMF Reference Model, Conatus now has a
repeatable framework that follows international standards. “Having a
system built according to the standards of the DIA TMF Reference Model
was important to us, especially considering the scope and complexity of
our clinical development activities,” added Mento. “Veeva has the
foresight to build a solution that reflects widely recognized
specifications.”
Conatus Vice President for Regulatory and Quality
Cindy Luchetti
added,
“Our previous system was not ideal for clinical trial records. Vault
eTMF gives us optimized capabilities with the added bonus of the DIA TMF
Reference Model. Now, we are completely paperless, using electronic
signatures for almost everything and recording all approvals in the
system. This kind of efficiency is critical to meeting our research and
development goals.”
Vault QualityDocs has also proven key to supporting Conatus’ efficiency
goals by delivering a single, global 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 Conatus team members to review documents
easily and management to monitor completion using simple dashboards.
“Vault QualityDocs has made immediate impact on our operational
efficiency and compliance,” added Luchetti. “Our staff always has access
to the current effective version of a document anywhere with web access
– whether in the office or on the road. It’s faster. It’s easier. And it
encourages them to follow our procedures. We also automatically track
who is reading or has been trained on which materials for simplified
compliance reporting.”
Vault QualityDocs and Vault eTMF, along with all Vault applications, are
designed to closely mirror familiar consumer web sites, providing an
intuitive interface for all users. “Vault is sleek and simple. Our
employees, and various external partners have picked it up without a
steep learning curve and only minimal training – literally just an hour
or two,” noted Mento. “Vault simplicity not only makes us more efficient
and it easier to share information, but it also encourages all users to
leverage the full functionality of the system for greater return on
investment.”
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.
Additional Information:
• For more information on Veeva Vault, please visit: www.veeva.com/vault/
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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 www.veeva.com.
Forward-looking Statements
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.
Source: Veeva Systems Inc.