Welcome!

Agile Computing Authors: Carmen Gonzalez, Liz McMillan, Greg Schulz, Patrick Hubbard, Pat Romanski

News Feed Item

Contract Research Organization Pharma Start Improves Audit Readiness with Paperless eTMF Solution from Veeva Systems

Improving audit readiness is one of the top goals for life sciences companies implementing a new electronic TMF solution today, and Pharma Start is no exception. Since adopting Veeva Systems’ cloud-based Vault eTMF solution, the contract research organization (CRO) is now prepared for inspection at all times and has the visibility needed to establish collaborative relationships with sponsors. Vault eTMF enables real-time information sharing in the cloud between Pharma Start teams, clinical partners, and its 75+ investigator sites around the globe. Additionally, Vault eTMF supports Pharma Start’s steadfast commitment to minimize its carbon footprint by eliminating the environmental impact of shipping paper, especially important in clinical work, where a single study can yield 5,000+ reams of paper a year, equal to 295 or more trees.

“We wanted to find a way to eliminate paper and improve process efficiency while complying with global requirements for a trial master file and adhering to our footprint goal,” explained Tom McGrady, Pharma Start’s vice president of quality assurance. The company turned to Vault eTMF for its flexible cloud architecture, ease of use, and ability to comply with 21 CFR Part 11. Plus, with TMF documents always up to date in Vault’s centrally accessible system, Pharma Start is better prepared for audit at all times. “We had a lot of criteria but Vault eTMF met all of them,” said McGrady.

Pharma Start initially considered other eTMF applications, but a cloud solution proved critical in order to remain true to its environmental goal. An in-depth study conducted by Accenture and Microsoft determined that the average 100-person company can reduce energy consumption and emissions by more than 90 percent by deploying all business applications in the cloud.1 Multitenant cloud applications, specifically, have proven to be greener alternatives to traditional systems, as they serve many customers that would otherwise each utilize their own resources to power, cool, and maintain the required infrastructure. Further, Veeva’s data centers use advanced technologies to optimize temperature control and reduce energy consumption.

“Securely accessible in the cloud and as easy to use as Amazon, Vault eTMF ensures both external and internal teams can fully leverage the system. Everyone can work in parallel so we don’t wait, for example, while physical documents are shipped to sites or a wet signature is captured via courier from locations all around the globe,” explained Rebecca Moraris, Pharma Start’s director of clinical operations. “Vault eTMF also provides total transparency and a better vantage point for sponsors, sites, and internal groups to identify problems early and fix them quickly.”

Since implementing Vault eTMF, Pharma Start has experienced major efficiency gains. “It really comes down to improved productivity,” added Moraris. “With Vault eTMF, processes and workflows can be automated so individual sites don’t have to recreate the wheel but simply pull down a template, complete it, and upload it back into Vault for all to see in real time. Placement into the eTMF happens automatically.”

Moraris continued, “We see tremendous hidden cost savings because TMF documents are uploaded, QC’d, and approved in the system all along the way. For study start-up, there’s less chasing documents and signatures, and at study close-out, we’ll eliminate the painful document reconciliation process.”

Vault eTMF is part of Veeva’s Development Suite, a cloud-based line of integrated content management applications for the life sciences industry. Supporting the R&D process from clinical trials to quality and regulatory submissions, the Veeva Development Suite provides pharmaceutical, biotechnology, and medical-device companies the ability to deploy a single content management system globally.

Pharma Start has joined the many life sciences organizations making the switch from paper to an electronic TMF and is working through the common challenges associated with change. “People always fear change, primarily because they worry about a loss of control. We’ve done training and adjusted our SOPs, but truly the best way to help the team make this transition has been to demonstrate the value of Vault eTMF. As soon as they see how much faster, easier, and more efficient it makes their jobs…change is easy. There’s no turning back now,” concluded Pharma Start President Christina Fleming.

For Additional Information:

About Pharma Start

Pharma Start provides outsourcing services, including preclinical assessment, clinical development, clinical pharmacology, translational medicine, medical writing, and regulatory submission and lifecycle management, supporting global pharmaceutical, biotechnology, and medical-device companies. For further information on Pharma Start, visit: http://www.pharma-start.com.

About Veeva Systems

Veeva Systems Inc. (NYSE:VEEV) 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 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 April 30, 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.

1 “Study of Cloud’s Impact on Environment,” commissioned by Accenture, Microsoft and WSP Environment and Energy, November 2010. For more, http://newsroom.accenture.com/article_display.cfm?article_id=5089

® 2014 Veeva Systems Inc. All rights reserved. Veeva and the Veeva logo are trademarks of Veeva Systems Inc. Veeva Systems Inc. owns other registered and unregistered trademarks.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
Things are changing so quickly in IoT that it would take a wizard to predict which ecosystem will gain the most traction. In order for IoT to reach its potential, smart devices must be able to work together. Today, there are a slew of interoperability standards being promoted by big names to make this happen: HomeKit, Brillo and Alljoyn. In his session at @ThingsExpo, Adam Justice, vice president and general manager of Grid Connect, will review what happens when smart devices don’t work togethe...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
In his session at @ThingsExpo, Sudarshan Krishnamurthi, a Senior Manager, Business Strategy, at Cisco Systems, will discuss how IT and operational technology (OT) work together, as opposed to being in separate siloes as once was traditional. Attendees will learn how to fully leverage the power of IoT in their organization by bringing the two sides together and bridging the communication gap. He will also look at what good leadership must entail in order to accomplish this, and how IT managers ca...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
TechTarget storage websites are the best online information resource for news, tips and expert advice for the storage, backup and disaster recovery markets. By creating abundant, high-quality editorial content across more than 140 highly targeted technology-specific websites, TechTarget attracts and nurtures communities of technology buyers researching their companies' information technology needs. By understanding these buyers' content consumption behaviors, TechTarget creates the purchase inte...
SYS-CON Events announced today that Cloud Academy will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud computing technologies. Ge...
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry’s single source for the cloud. Fusion’s advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including cloud...
Your homes and cars can be automated and self-serviced. Why can't your storage? From simply asking questions to analyze and troubleshoot your infrastructure, to provisioning storage with snapshots, recovery and replication, your wildest sci-fi dream has come true. In his session at @DevOpsSummit at 20th Cloud Expo, Dan Florea, Director of Product Management at Tintri, will provide a ChatOps demo where you can talk to your storage and manage it from anywhere, through Slack and similar services ...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ca...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business. Though, IoT is far more complex than most firms expected with a majority of IoT projects having failed. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, Chief IoTologist at Wipro, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology portfolios and business models to adopt and leverage IoT. He will delve in...
In the enterprise today, connected IoT devices are everywhere – both inside and outside corporate environments. The need to identify, manage, control and secure a quickly growing web of connections and outside devices is making the already challenging task of security even more important, and onerous. In his session at @ThingsExpo, Rich Boyer, CISO and Chief Architect for Security at NTT i3, will discuss new ways of thinking and the approaches needed to address the emerging challenges of securit...