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

SOURCE: IDDI

BARCELONA, SPAIN — 22 Oct., 2013 – 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.

“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 Danielson.

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 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 www.veeva.com.