|By David Stanley||
|July 9, 2014 09:45 AM EDT||
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.
"For over 25 years we have been working with a lot of enterprise customers and we have seen how companies create applications. And now that we have moved to cloud computing, mobile, social and the Internet of Things, we see that the market needs a new way of creating applications," stated Jesse Shiah, CEO, President and Co-Founder of AgilePoint Inc., in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 06:00 PM EST Reads: 1,204
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 06:00 PM EST Reads: 1,042
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product Marketing Manager at Serena Software, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 06:00 PM EST Reads: 218
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 06:00 PM EST Reads: 301
As enterprises engage with Big Data technologies to develop applications needed to meet operational demands, new computation fabrics are continually being introduced. To leverage these new innovations, organizations are sacrificing market opportunities to gain expertise in learning new systems. In his session at Big Data Expo, Supreet Oberoi, Vice President of Field Engineering at Concurrent, Inc., discussed how to leverage existing infrastructure and investments and future-proof them against e...
Dec. 17, 2014 06:00 PM EST Reads: 1,233
Mobile commerce traffic is surpassing desktop, yet less than 20% of sales in the U.S. are mobile commerce sales. In his session at 15th Cloud Expo, Dan Franklin, Segment Manager, Commerce, at Verizon Digital Media Services, defined mobile devices and discussed how next generation means simplification. It means taking your digital content and turning it into instantly gratifying experiences.
Dec. 17, 2014 05:45 PM EST Reads: 518
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session a...
Dec. 17, 2014 05:15 PM EST Reads: 1,142
"Ulunsoft is a start-up that focuses on how enterprises build cloud-based IT infrastructure for business," explained Haibo Zhu, President of Ulunsoft Corp, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 05:00 PM EST Reads: 967
"Desktop as a Service is emerging as a very big trend. One of the big influencers of this – for Esri – is that we have a large user base that uses virtualization and they are looking at Desktop as a Service right now," explained John Meza, Product Engineer at Esri, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 04:30 PM EST Reads: 1,367
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, 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. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the ...
Dec. 17, 2014 04:30 PM EST Reads: 1,066
"At our booth we are showing how to provide trust in the Internet of Things. Trust is where everything starts to become secure and trustworthy. Now with the scaling of the Internet of Things it becomes an interesting question – I've heard numbers from 200 billion devices next year up to a trillion in the next 10 to 15 years," explained Johannes Lintzen, Vice President of Sales at Utimaco, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in San...
Dec. 17, 2014 04:15 PM EST Reads: 1,222
"Application monitoring and intelligence can smooth the path in a DevOps environment. In a DevOps environment you see constant change. If you are trying to monitor things in a constantly changing environment, you're going to spend a lot of your job fixing your monitoring," explained Todd Rader, Solutions Architect at AppDynamics, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 04:00 PM EST Reads: 1,414
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile ...
Dec. 17, 2014 11:45 AM EST Reads: 1,357
"SOASTA built the concept of cloud testing in 2008. It's grown from rather meager beginnings to where now we are provisioning hundreds of thousands of servers on a daily basis on behalf of customers around the world to test their applications," explained Tom Lounibos, CEO of SOASTA, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 11:30 AM EST Reads: 1,142
“We are a managed services company. We have taken the key aspects of the cloud and the purposed data center and merged the two together and launched the Purposed Cloud about 18–24 months ago," explained Chetan Patwardhan, CEO of Stratogent, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 17, 2014 11:00 AM EST Reads: 1,049
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core...
Dec. 16, 2014 11:45 PM EST Reads: 1,187
"Verizon Digital Media Services is responsible for the broadcast, video and content delivery network that accelerates, scales and helps our customers reach end users with all kinds of video and web content," stated James Segil, CMO of Verizon Digital Media Services, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 16, 2014 10:00 PM EST Reads: 1,153
SYS-CON Events announced today that Creative Business 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. Creative Business Solutions is the top stocking authorized HP Renew Distributor in the U.S. Based out of Long Island, NY, Creative Business Solutions offers a one-stop shop for a diverse range of products including Proliant, Blade and Industry Standard Servers, Networking, Server Options and...
Dec. 16, 2014 09:30 PM EST Reads: 993
You use an agile process; your goal is to make your organization more agile. But what about your data infrastructure? The truth is, today's databases are anything but agile - they are effectively static repositories that are cumbersome to work with, difficult to change, and cannot keep pace with application demands. Performance suffers as a result, and it takes far longer than it should to deliver new features and capabilities needed to make your organization competitive. As your application an...
Dec. 16, 2014 08:00 PM EST Reads: 1,185
“We are strong believers in the DevOps movement and our staff has been doing DevOps for large enterprise environments for a number of years. The solution that we build is intended to allow DevOps teams to do security at the speed of DevOps," explained Justin Lundy, Founder & CTO of Evident.io, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 16, 2014 06:00 PM EST Reads: 916