Welcome!

SDN Journal Authors: Pat Romanski, Stephen Boyer, Mark Cravotta, Elizabeth White, Greg Schulz

Related Topics: Cloud Expo, Java, SOA & WOA, Linux, Web 2.0, Big Data Journal, SDN Journal

Cloud Expo: Case Study

Case Study: Implementing a Cloud-Based Information Management System

Cloud-based information management helps pharmaceutical startup optimize the management of their FDA submission documents

In the pharmaceutical industry, the drug development clock is ticking at the rate of warp-speed. As a result, companies are constantly looking for solutions to help them accelerate time to market - and many are realizing that implementing a cloud-based information management system can bring much needed clarity, organization and efficiency to the complex documentation processes and protocols required to bring a drug to market.

One such company is Singapore-based Lypanosys, an early-stage pharmaceutical company developing a clinically differentiated drug for the dermatology market. Blaine Ah Yuk-Winters, the project manager of the geographically dispersed pharmaceutical startup, describes Lypanosys as a virtual company in the sense that its manufacturing, preclinical, and clinical development activities are spread across the US, Asia, and Australia.

Addressing the Documentation Challenges within the Pharmaceutical Industry
According to a survey by the consulting group Ovum, pharmaceutical companies are ahead of other industries when it comes to adopting enterprise applications, such as enterprise resource planning (ERP) and customer relationship management (CRM) solutions, but lag behind in the adoption of business intelligence solutions such as regulatory tracking/management systems that can harness data more productively. Furthermore, an FDA CTD/eCTD (Electronic Common Technical Document) quality reviewer survey noted that only about half of sponsors do a good or excellent job in organizing documents according to CTD best practices.

While this may help explain why some pharmaceutical firms have been slow to implement hosted document and data management systems, Lypanosys is the sort of international venture that cloud computing was invented for.

"We found a solution that enables us to get all of our files into a cloud-based enterprise content management system, which we can access wherever we are," said Ah Yuk-Winters.

The cloud has worked well Lypanosys so far. All of the company's documents reside on a hosted server and can be easily shared among project participants regardless of location. As a result, Lypanosys can operate virtually - or "office-lessly."

The Implications and Repercussions of Poor Information Management
Poor information management can create a bottleneck for companies on multiple levels, as well as add unnecessary cost burdens. For example, take the cost of storage: failing to manage data appropriately results in the retention of redundant information and records, which occupies storage space within a system. There's also the time-cost associated with chasing down information needed to meet regulatory requirements or to make an important business decision.

According to Ah Yuk-Winters, these were important considerations during Lypanosys' evaluation of various cloud-based information management systems. Unfortunately, many cloud offerings, such as the first one Lypanosys tried, are frustratingly slow.

"With the other system we tried, it was not so much the time it took uploading and downloading documents, it was the time it took maneuvering inside the interface. It was quite sluggish. When you clicked on a folder, it would often take 15 seconds to open."

The initial cloud system Lypanosys deployed structured files in multiple levels of traditional folders and subfolders. To get to a file they wanted, users could have to wait several minutes for the interface to open the final folder location - not including the time to download the document.

"We just couldn't employ the system for daily use," added Ah Yuk-Winters.

However, the system Lypanosys ultimately selected and deployed, M-Files, delivered the required performance at both the users' desktop interface as well as its remotely hosted servers.

The solution integrates its document and workflow controls in Windows Explorer and Microsoft Office as well as any other Windows application, so the way information is saved and retrieved is already familiar to most PC users. And because its search capability is based on efficient indexed metadata and "full text" content - rather than traditional folder structures - users can sort through content and find the files or other important information they need in seconds. Even with larger files, such as submission documents for the FDA, M-Files' unique caching and server synchronization capabilities enable silent and quick uploading in the background, so users can move on to other tasks. The result is performance that feels like the system is running on users' local PCs, yet information actually resides in the cloud.

"One of our directors needed a report to provide to a potential investor. He was actually in an airport in transit in Asia and was able to quickly locate the file and send it off. He was impressed with how easily that went. We are very happy with the system's responsiveness," continued Ah Yuk-Winters.

On the server side, the information management system runs on the Windows Azure cloud platform, which operates from Microsoft data centers around the globe. With the Windows Azure platform, the system delivers flexibility and reliability to users, whether they're in Auckland or Ankara.

"For accessing content, it's really quite fast," says Ah Yuk-Winters. "The searching and retrieving features are great. The way you can sort documents into different types and groups with metadata is fantastic."

Keeping Order in the Cloud
A significant advantage of cloud-based systems lies in their reliability and scalability. Raw storage without other information management capabilities, such as solutions offered by popular file sharing services like Dropbox and Box, can quickly turn into a disorderly mess of folders, just as it does with on-site "on-premise" servers when traditional Windows folder structures are used for categorizing and storing documents.

An effective hosted information management solution can manage hundreds of thousands -- and even millions - of documents. Managed documents and other types of information can range from lab notebook entries, study data, biomarkers, formulation studies, and statistical analyses to GLP (Good Laboratory Practice) compliance documents, patent analyses, market research, patent filings, product commercial path scenarios, IND (Investigational New Drug) submission strategies, toxicology reports, templates, and the list goes on and on...

A cloud-based document and information management solution should also provide collaboration features, such as the ability to easily share files with internal employees or external partners and check-in/check-out to manage document creation and editing in a team environment, as well as workflow features for automating business processes, the ability to quickly scan paper documents into the system with optical character recognition (OCR) to create searchable PDF files, a user-friendly interface, tracking/audit trail features, support for compliance with regulations such as FDA 21 CFR Part 11, EU GMP Annex 11, etc., version management for tracking document and information history, reporting features and compatibility with training software controls. The system should also be compatible with existing legacy enterprise systems, such as ERP and CRM solutions.

Lypanosys found a solution that addressed these critical needs, and as a result, was able to bring order and efficiency to their chaotic document and information universe by organizing and indexing every item in the centralized cloud repository. The solution also featured flexible yet strict access permissions functionality and a complete compulsory version history for everything.

"M-Files saved us a lot of time over what we had going on with just a folder structure," says Ah Yuk-Winters. "Before, when we had to submit a filing to the FDA it was difficult to find the relevant documentation we needed. There were duplicates everywhere. Trying to find a document and not knowing which version was the latest was a nightmare. Automatic versioning is essential when you have multiple people in different locations revising the same work."

Flexible permission controls also enable Lypanosys to authorize third-party consultants and advisors to sign in to the company's system to access selected materials and then save their own versions of documents, without the risk of upsetting organizational processes.

"The ability to share files with consultants overseas has proved very handy. They can pull files whenever they want at any time they want."

Realizing the Benefits of Hosted Information Management
An information management system can help pharmaceutical companies and related organizations become more responsive by making it easy and fast to locate the latest version of any document or information object, dramatically reducing the time associated with document requests, audits, and submissions. It can also help enforce security, protect and archive institutional knowledge, and streamline regulatory compliance procedures. Personnel resources are also conserved by reducing the need to handle and store paper.

With an effective information management system in place, pharmaceutical companies can literally shave years off the drug development clock by getting all company documentation, information and processes under control, while also providing insight and business intelligence into how information is being used and where company processes can be improved. This proactive approach towards information management, process automation and consistent tracking leads to higher quality reviews and efficient, successful audits, greatly reducing the risk of noncompliance while providing 100% traceability of all documents, records and cases across the organization.

Couldn't all this be done with a traditional on-premise solution too? Yes, it could, but the cloud changes the equation by eliminating the need to purchase and configure servers, as well as reducing the IT resources needed to maintain them. Further it reduces upfront costs, allowing organizations to pay for cloud solutions with smaller, more manageable monthly payments.

If your organization is experiencing challenges with managing and finding information, or could benefit from improving the way submissions and audits are handled, a modern information management system can help - and the cloud provides a compelling alternative that eliminates barriers that may have prevented implementing such a system in the past.

More Stories By David Stanley

David Stanley is the QMS Product Manager at M-Files Corporation. M-Files enterprise information management (EIM) solutions eliminate information silos and provide quick and easy access to the right content from any core business system and device. Thousands of businesses in over 100 countries use M-Files on-premise, in the cloud or in hybrid environments to improve productivity and quality, and to ensure compliance with industry regulations and standards. For more information, visit www.m-files.com.

Comments (0)

Share your thoughts on this story.

Add your comment
You must be signed in to add a comment. Sign-in | Register

In accordance with our Comment Policy, we encourage comments that are on topic, relevant and to-the-point. We will remove comments that include profanity, personal attacks, racial slurs, threats of violence, or other inappropriate material that violates our Terms and Conditions, and will block users who make repeated violations. We ask all readers to expect diversity of opinion and to treat one another with dignity and respect.


Cloud Expo Breaking News
It’s time to face reality: "Americans are from Mars, Europeans are from Venus," and in today’s increasingly connected world, understanding “inter-planetary” alignments and deviations is mission-critical for cloud. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance Strategy Leader at Cisco Systems, will discuss cultural expectations of privacy based on new research across these elements.
SYS-CON Events announced today that Cloudian, Inc., the leading provider of hybrid cloud storage solutions, has been named “Bronze Sponsor” of SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Cloudian is a Foster City, Calif.-based software company specializing in cloud storage. Cloudian HyperStore® is an S3-compatible cloud object storage platform that enables service providers and enterprises to build reliable, affordable and scalable hybrid cloud storage solutions. Cloudian actively partners with leading cloud computing environments including Amazon Web Services, Citrix Cloud Platform, Apache CloudStack, OpenStack and the vast ecosystem of S3 compatible tools and applications. Cloudian's customers include Vodafone, Nextel, NTT, Nifty, and LunaCloud. The company has additional offices in China and Japan.
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at Internet of @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, will discuss the underlying factors that are driving the economics of intelligent systems. Discover how hardware commoditization, the ubiquitous nature of connectivity, and the emergence of Big Data and analysis are providing the pull to meet customer expectations of a widely connected, multi-dimensional universe of people, things, and information.
There will be 50 billion Internet connected devices by 2020. Today, every manufacturer has a propriety protocol and an app. How do we securely integrate these "things" into our lives and businesses in a way that we can easily control and manage? Even better, how do we integrate these "things" so that they control and manage each other so our lives become more convenient or our businesses become more profitable and/or safe? We have heard that the best interface is no interface. In his session at Internet of @ThingsExpo, Chris Matthieu, Co-Founder & CTO at Octoblu, Inc., will discuss how these devices generate enough data to learn our behaviors and simplify/improve our lives. What if we could connect everything to everything? I'm not only talking about connecting things to things but also systems, cloud services, and people. Add in a little machine learning and artificial intelligence and now we have something interesting...
SYS-CON Events announced today that Esri has been named “Bronze Sponsor” of SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Esri inspires and enables people to positively impact the future through a deeper, geographic understanding of the changing world around them. For more information, visit http://www.esri.com.
After a couple of false starts, cloud-based desktop solutions are picking up steam, driven by trends such as BYOD and pervasive high-speed connectivity. In his session at 15th Cloud Expo, Seth Bostock, CEO of IndependenceIT, cuts through the hype and the acronyms, and discusses the emergence of full-featured cloud workspaces that do for the desktop what cloud infrastructure did for the server. He’ll discuss VDI vs DaaS, implementation strategies and evaluation criteria.
Cloud computing started a technology revolution; now DevOps is driving that revolution forward. By enabling new approaches to service delivery, cloud and DevOps together are delivering even greater speed, agility, and efficiency. No wonder leading innovators are adopting DevOps and cloud together! In his session at DevOps Summit, Andi Mann, Vice President of Strategic Solutions at CA Technologies, will explore the synergies in these two approaches, with practical tips, techniques, research data, war stories, case studies, and recommendations.
Cloud Computing is evolving into a Big Three of Amazon Web Services, Google Cloud, and Microsoft Azure. Cloud 360: Multi-Cloud Bootcamp, being held Nov 4–5, 2014, in conjunction with 15th Cloud Expo in Santa Clara, CA, delivers a real-world demonstration of how to deploy and configure a scalable and available web application on all three platforms. The Cloud 360 Bootcamp, led by Janakiram MSV, an analyst with Gigaom Research, is the first bootcamp that introduces the core concepts of Infrastructure as a Service (IaaS) based on the workings of the Big Three platforms – Amazon EC2, Google Compute Engine, and Azure VMs. Bootcamp attendees will get to see the big picture and also receive the knowledge needed to make the best cloud decisions for their business applications and entire enterprise IT organization.
“Distrix fits into the overall cloud and IoT model around software-defined networking. There’s a broad category around software-defined networking that’s focused on data center, and we focus on the WAN,” explained Jay Friedman, President of Distrix, in this SYS-CON.tv interview at the Internet of @ThingsExpo, held June 10-12, 2014, at the Javits Center in New York City. Internet of @ThingsExpo 2014 Silicon Valley, November 4–6, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading IoT industry players in the world.
The Internet of Things promises to transform businesses (and lives), but navigating the business and technical path to success can be difficult to understand. In his session at 15th Internet of @ThingsExpo, Chad Jones, Vice President, Product Strategy of LogMeIn's Xively IoT Platform, will show you how to approach creating broadly successful connected customer solutions using real world business transformation studies including New England BioLabs and more.
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using the URL as a basic building block, we open this up and get the same resilience that the web enjoys.
“The Internet of Things is a wave that has arrived and it’s growing really fast. The concern at Aria Systems is making sure that people understand the ramifications of their attempts to monetize whatever it is they build on the Internet of Things," explained C Brendan O’Brien, Co-founder and Chief Architect at Aria Systems, in this SYS-CON.tv interview at the Internet of @ThingsExpo, held June 10-12, 2014, at the Javits Center in New York City. Internet of @ThingsExpo 2014 Silicon Valley, November 4–6, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading IoT industry players in the world.
The Internet of Things is a natural complement to the cloud and related technologies such as Big Data, analytics, and mobility. In his session at Internet of @ThingsExpo, Joe Weinman will lay out four generic strategies – digital disciplines – to exploit emerging digital technologies for strategic advantage. Joe Weinman has held executive leadership positions at Bell Labs, AT&T, Hewlett-Packard, and Telx, in areas such as corporate strategy, business development, product management, operations, and R&D.
SYS-CON Events announced today that DevOps.com has been named “Media Sponsor” of SYS-CON's “DevOps Summit at Cloud Expo,” which will take place on June 10–12, 2014, at the Javits Center in New York City, New York. DevOps.com is where the world meets DevOps. It is the largest collection of original content relating to DevOps on the web today Featuring up-to-the-minute news, feature stories, blogs, bylined articles and more, DevOps.com is where the thought leaders of the DevOps movement make their ideas known.
There are 182 billion emails sent every day, generating a lot of data about how recipients and ISPs respond. Many marketers take a more-is-better approach to stats, preferring to have the ability to slice and dice their email lists based numerous arbitrary stats. However, fundamentally what really matters is whether or not sending an email to a particular recipient will generate value. Data Scientists can design high-level insights such as engagement prediction models and content clusters that allow marketers to cut through the noise and design their campaigns around strong, predictive signals, rather than arbitrary statistics. SendGrid sends up to half a billion emails a day for customers such as Pinterest and GitHub. All this email adds up to more text than produced in the entire twitterverse. We track events like clicks, opens and deliveries to help improve deliverability for our customers – adding up to over 50 billion useful events every month. While SendGrid data covers only abo...