Click here to close now.

Welcome!

Java Authors: Pat Romanski, Liz McMillan, Dan Ristic, Elizabeth White, Kevin Benedict

Related Topics: Cloud Expo, Java, Microservices Journal, 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.


@ThingsExpo Stories
SYS-CON Events announced today that Ciqada will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Ciqada™ makes it easy to connect your products to the Internet. By integrating key components - hardware, servers, dashboards, and mobile apps - into an easy-to-use, configurable system, your products can quickly and securely join the internet of things. With remote monitoring, control, and alert messaging capability, you will meet your customers' needs of tomorrow - today! Ciqada. Let your products take flight. For more inform...
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applications - creating more engaging experiences for their customers and boosting collaboration and productiv...
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Company’s core communications platform enables the delivery of a range of enterprise and consumer calling...
VoxImplant has announced full WebRTC support in the newest versions of its Android SDK and iOS SDK. The updated SDKs, which enable audio and video calls on mobile devices, are now compatible with the WebRTC standard to allow any mobile app to communicate with WebRTC-enabled browsers, including Google Chrome, Mozilla Firefox, Opera, and, when available, Microsoft Spartan. The WebRTC-updated SDKs represent VoxImplant's continued leadership in simplifying the development of real-time communications (RTC) services for app developers. VoxImplant (built by Zingaya, the real-time communication servi...
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquired by Aditi Technologies. He is a Microsoft Regional Director for Hyderabad, India, and one of the f...
SYS-CON Events announced today that Optimal Design, an Internet of Things solution provider, will exhibit at SYS-CON's Internet of @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Optimal Design is an award winning product development firm offering industrial design and engineering services to the consumer, medical, and defense markets.
SYS-CON Events announced today that Vicom Computer Services, Inc., a provider of technology and service solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. They are located at booth #427. Vicom Computer Services, Inc. is a progressive leader in the technology industry for over 30 years. Headquartered in the NY Metropolitan area. Vicom provides products and services based on today’s requirements around Unified Networks, Cloud Computing strategies, Virtualization around Software defined Data Ce...
What exactly is a cognitive application? In her session at 16th Cloud Expo, Ashley Hathaway, Product Manager at IBM Watson, will look at the services being offered by the IBM Watson Developer Cloud and what that means for developers and Big Data. She'll explore how IBM Watson and its partnerships will continue to grow and help define what it means to be a cognitive service, as well as take a look at the offerings on Bluemix. She will also check out how Watson and the Alchemy API team up to offer disruptive APIs to developers.
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal today!
With IoT exploding, massive data will transform businesses with opportunities to monetize almost anything that can be measured. In this C-Level Roundtable Discussion at @ThingsExpo, Brendan O’Brien, Aria Systems Co-founder and Chief Evangelist, will lead an expert panel of consultants, thought leaders and practitioners who will look at these new monetization trends, discuss the implications, and detail lessons learned from their collective experience. Finally, the panel will point the way forward for enterprises who wish to leverage the resulting complex recurring revenue models, adding valu...
How is unified communications transforming the way businesses operate? In his session at WebRTC Summit, Arvind Rangarajan, Director of Product Marketing at BroadSoft, will discuss how to extend unified communications experience outside the enterprise through WebRTC. He will also review use cases across different industry verticals. Arvind Rangarajan is Director, Product Marketing at BroadSoft. He has over 19 years of experience in the telecommunications industry in various roles such as Software Development, Product Management and Product Marketing, applied across Wireless, Unified Communic...
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? Join this panel of experts as they peel away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud environment, and we must architect and code accordingly. At the very least, you’ll have no problem filling in your buzzword bingo cards.
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, will discuss how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at the same time reduce Time to Market (TTM) by using plug and play capabilities offered by a robust I...
@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 case) takes into account the number and quality of contextual references that a user receives.
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures traffic gets delivered faster, safer, and more reliably than ever.
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what the future may hold. Mike Kavis is Vice President & Principal Cloud Architect at Cloud Technology Pa...
The only place to be June 9-11 is Cloud Expo & @ThingsExpo 2015 East at the Javits Center in New York City. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT & Big Data companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterprise. Speakers from all over the world will be hand-picked for their ability to explore the economic strategies that utility/cloud computing provides. Whether public, private, or in a hybrid form, clo...
The WebRTC Summit 2015 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
As Marc Andreessen says software is eating the world. Everything is rapidly moving toward being software-defined – from our phones and cars through our washing machines to the datacenter. However, there are larger challenges when implementing software defined on a larger scale - when building software defined infrastructure. In his session at 16th Cloud Expo, Boyan Ivanov, CEO of StorPool, will provide some practical insights on what, how and why when implementing "software-defined" in the datacenter.
While not quite mainstream yet, WebRTC is starting to gain ground with Carriers, Enterprises and Independent Software Vendors (ISV’s) alike. WebRTC makes it easy for developers to add audio and video communications into their applications by using Web browsers as their platform. But like any market, every customer engagement has unique requirements, as well as constraints. And of course, one size does not fit all. In her session at WebRTC Summit, Dr. Natasha Tamaskar, Vice President, Head of Cloud and Mobile Strategy at GENBAND, will explore what is needed to take a real time communications ...