Welcome!

Agile Computing Authors: Derek Weeks, Jason Bloomberg, Elizabeth White, AppDynamics Blog, Liz McMillan

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
SYS-CON Events announced today that DatacenterDynamics has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY. DatacenterDynamics is a brand of DCD Group, a global B2B media and publishing company that develops products to help senior professionals in the world's most ICT dependent organizations make risk-based infrastructure and capacity decisions.
So, you bought into the current machine learning craze and went on to collect millions/billions of records from this promising new data source. Now, what do you do with them? Too often, the abundance of data quickly turns into an abundance of problems. How do you extract that "magic essence" from your data without falling into the common pitfalls? In her session at @ThingsExpo, Natalia Ponomareva, Software Engineer at Google, will provide tips on how to be successful in large scale machine lear...
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, will discuss how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technol...
The increasing popularity of the Internet of Things necessitates that our physical and cognitive relationship with wearable technology will change rapidly in the near future. This advent means logging has become a thing of the past. Before, it was on us to track our own data, but now that data is automatically available. What does this mean for mHealth and the "connected" body? In her session at @ThingsExpo, Lisa Calkins, CEO and co-founder of Amadeus Consulting, will discuss the impact of wea...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...
In his session at @ThingsExpo, Chris Klein, CEO and Co-founder of Rachio, will discuss next generation communities that are using IoT to create more sustainable, intelligent communities. One example is Sterling Ranch, a 10,000 home development that – with the help of Siemens – will integrate IoT technology into the community to provide residents with energy and water savings as well as intelligent security. Everything from stop lights to sprinkler systems to building infrastructures will run ef...
Digital payments using wearable devices such as smart watches, fitness trackers, and payment wristbands are an increasing area of focus for industry participants, and consumer acceptance from early trials and deployments has encouraged some of the biggest names in technology and banking to continue their push to drive growth in this nascent market. Wearable payment systems may utilize near field communication (NFC), radio frequency identification (RFID), or quick response (QR) codes and barcodes...
SYS-CON Events announced today that Stratoscale, the software company developing the next generation data center operating system, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Stratoscale is revolutionizing the data center with a zero-to-cloud-in-minutes solution. With Stratoscale’s hardware-agnostic, Software Defined Data Center (SDDC) solution to store everything, run anything and scale everywhere...
Angular 2 is a complete re-write of the popular framework AngularJS. Programming in Angular 2 is greatly simplified – now it's a component-based well-performing framework. This immersive one-day workshop at 18th Cloud Expo, led by Yakov Fain, a Java Champion and a co-founder of the IT consultancy Farata Systems and the product company SuranceBay, will provide you with everything you wanted to know about Angular 2.
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
You deployed your app with the Bluemix PaaS and it's gaining some serious traction, so it's time to make some tweaks. Did you design your application in a way that it can scale in the cloud? Were you even thinking about the cloud when you built the app? If not, chances are your app is going to break. Check out this webcast to learn various techniques for designing applications that will scale successfully in Bluemix, for the confidence you need to take your apps to the next level and beyond.
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
SYS-CON Events announced today that Ericsson has been named “Gold Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Ericsson is a world leader in the rapidly changing environment of communications technology – providing equipment, software and services to enable transformation through mobility. Some 40 percent of global mobile traffic runs through networks we have supplied. More than 1 billion subscribers around the world re...
There is an ever-growing explosion of new devices that are connected to the Internet using “cloud” solutions. This rapid growth is creating a massive new demand for efficient access to data. And it’s not just about connecting to that data anymore. This new demand is bringing new issues and challenges and it is important for companies to scale for the coming growth. And with that scaling comes the need for greater security, gathering and data analysis, storage, connectivity and, of course, the...
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, will discuss how research has demonstrated the value of Machine Learning in delivering next generation analytics to im...
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.