Last updated on April 18, 2014 at 17:24 EDT

IDDI Increases Audit-Readiness and Simplifies Collaboration by Switching to Veeva Systems’ Vault eTMF Solution

October 22, 2013

BARCELONA, Spain, October 22, 2013 /PRNewswire/ –

Cloud platform supports CRO’s global client base and long-term paperless TMF


International Drug Development Institute (IDDI), an international functional Contract
Research Organisation (CRO) headquartered in Belgium, replaced its mix of a paper-based
trial master file (TMF) and e-rooms with Veeva Systems’ cloud-based Vault eTMF solution,
part of Veeva’s Development Suite. As a CRO that collects, analyses, and reports all data
from international phase I through IV clinical trials for sponsors throughout the US,
Europe, and Asia, IDDI wanted a single, centralised system to streamline auditing and
collaboration. After evaluating five systems, IDDI chose Vault eTMF for its document
tracking capabilities and globally accessible cloud platform.

http://photos.prnewswire.com/prnh/20120425/527164 )

“We were looking to move from our hybrid system to a single, digital solution for TMF
management to improve quality, efficiency, and control while allowing our colleagues and
clients to access our data through the cloud,” said Linda Danielson, IDDI’s chief
operating officer. “We were very impressed with Veeva’s successful track record in the
life sciences industry. Veeva also came with strong references for customer support and
cloud technology innovation.”

Vault eTMF met each of IDDI’s key selection criteria: cost efficient pricing
structure, a framework built on the TMF reference model with full audit trails, and an
intuitive user interface. Most importantly, IDDI wanted a system that would support its
global workforce. “The fact that Vault eTMF is easily accessible without a VPN is very
important to us for efficient collaboration across regions,” added Danielson.

“As a CRO, we need our clients to review and approve many of our documents, so it’s
critical that we can quickly and easily share them,” continued Danielson. “With our old
system, clients had to print, sign, and scan documents. They then had to upload the
documents to a shared e-room or email them back – not an easy or efficient process. It was
also difficult to track and to ensure that we received everything back. Vault eTMF enables
effective collaboration between both parties since sponsors can review, edit, and approve
documents in real time.”

Like all companies involved in clinical trials, IDDI places a high value on audit
readiness. Vault eTMF’s document management features, audit trails, and auditor role
functionality enable IDDI to grant auditors access to a system that contains all of the
correct documents for review. “Vault eTMF’s versioning control is key to helping us be
prepared for an audit. We know which version we are working on and can automatically
provide documented audit trails that show who has accessed which documents and when,” said

IDDI implemented a pilot of Vault eTMF for a phase III clinical trial study in less
than four weeks, and the organisation was able to define rights, workflows, security
models, and life cycles all within that time period. The company will migrate many of its
85 active studies into Vault eTMF later this year followed by 40 new studies through 2014.

“Veeva’s professional services team was very easy to work with, fast, and responsive.
We were extremely happy to be up and running with a solution that fully met our business
requirements so quickly,” concluded Danielson.

About Veeva Development Suite

Vault eTMF is part of the Veeva Development Suite, the only cloud-based suite of
integrated content management applications for the life sciences industry. Spanning every
major part of a life sciences company – from R&D and clinical trials to quality and
manufacturing – the Veeva Development Suite gives pharmaceutical, biotechnology, and
medical device companies the ability to deploy a single content management system
globally. All Development Suite applications offer real-time reporting and dashboards, an
intuitive web interface, and a true multitenant cloud architecture that continuously
delivers rapid innovation.

About IDDI

IDDI offers advanced biostatistical and eClinical services to pharmaceutical and
biotechnology companies in several disease areas, including oncology and ophthalmology.
IDDI optimises the clinical development of drugs, biologics and devices thanks to proven
expertise and operational excellence. Founded in 1991, IDDI is a privately owned company
headquartered in Louvain-la-Neuve, Belgium with offices in Boston and Houston, USA. For
more information visit http://www.iddi.com.

About Veeva Systems

Veeva Systems 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 170 customers, ranging from the world’s largest pharmaceutical companies to
emerging biotechs. Founded in 2007, Veeva is headquartered in the San Francisco Bay Area,
with offices in Philadelphia, Barcelona, Budapest, London, Paris, Beijing, Shanghai,
Osaka, Tokyo, Sydney, and Singapore. For more information, visit http://www.veeva.com.

        Lisa Barbadora
        Public Relations
        Veeva Systems Inc.



SOURCE Veeva Systems

Source: PR Newswire