|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.
SYS-CON Events announced today that Harbinger Systems will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Harbinger Systems is a global company providing software technology services. Since 1990, Harbinger has developed a strong customer base worldwide. Its customers include software product companies ranging from hi-tech start-ups in Silicon Valley to leading product companies in the US a...
Jul. 7, 2015 05:45 PM EDT Reads: 2,447
Announcing @ProfitBricksUSA to Exhibit at @CloudExpo Silicon Valley | #IoT #API #DevOps #Microservices
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the...
Jul. 7, 2015 05:00 PM EDT Reads: 2,266
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than
Jul. 7, 2015 05:00 PM EDT Reads: 2,238
[video] Logging and Monitoring with @Sematext Founder @OtisG | @DevOpsSummit #DevOps #Logging #Monitoring
"We got started as search consultants. On the services side of the business we have help organizations save time and save money when they hit issues that everyone more or less hits when their data grows," noted Otis Gospodnetić, Founder of Sematext, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 7, 2015 04:45 PM EDT Reads: 1,712
[slides] Policy in Hybrid Cloud By @DerekCollison | @CloudExpo #API #DevOps #Containers #Microservices
Enterprises are turning to the hybrid cloud to drive greater scalability and cost-effectiveness. But enterprises should beware as the definition of “policy” varies wildly. Some say it’s the ability to control the resources apps’ use or where the apps run. Others view policy as governing the permissions and delivering security. Policy is all of that and more. In his session at 16th Cloud Expo, Derek Collison, founder and CEO of Apcera, explained what policy is, he showed how policy should be arch...
Jul. 7, 2015 04:30 PM EDT Reads: 803
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, 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. Meanwhile, 94% of enterprises ar...
Jul. 7, 2015 04:00 PM EDT Reads: 1,948
Microservices are individual units of executable code that work within a limited framework. They are extremely useful when placed within an architecture of numerous microservices. On June 24th, 2015 I attended a webinar titled “How to Share Share-Nothing Microservices,” hosted by Jason Bloomberg, the President of Intellyx, and Scott Edwards, Director Product Marketing for Service Virtualization at CA Technologies. The webinar explained how to use microservices to your advantage in order to deliv...
Jul. 7, 2015 03:45 PM EDT Reads: 730
What’s New in the World of Application Analytics By @MikeAnand | @DevOpsSummit #DevOps #API #APM #Microservices
Software is eating the world. The more it eats, the bigger the mountain of data and wealth of valuable insights to digest and act on. Forward facing customer-centric IT organizations, leaders and professionals are looking to answer questions like how much revenue was lost today from platinum users not converting because they experienced poor mobile app performance. This requires a single, real-time pane of glass for end-to-end analytics covering business, customer, and IT operational data.
Jul. 7, 2015 03:45 PM EDT Reads: 1,059
In the midst of the widespread popularity and adoption of cloud computing, it seems like everything is being offered “as a Service” these days: Infrastructure? Check. Platform? You bet. Software? Absolutely. Toaster? It’s only a matter of time. With service providers positioning vastly differing offerings under a generic “cloud” umbrella, it’s all too easy to get confused about what’s actually being offered. In his session at 16th Cloud Expo, Kevin Hazard, Director of Digital Content for SoftL...
Jul. 7, 2015 03:45 PM EDT Reads: 2,682
[video] Infrastructure as a Toolbox By @SoftLayer at @CloudExpo New York | #IoT #API #Containers #Microservices
Countless business models have spawned from the IaaS industry. Resell Web hosting, blogs, public cloud, and on and on. With the overwhelming amount of tools available to us, it's sometimes easy to overlook that many of them are just new skins of resources we've had for a long time. In his General Session at 16th Cloud Expo, Phil Jackson, Lead Technology Evangelist at SoftLayer, broke down what we've got to work with and discuss the benefits and pitfalls to discover how we can best use them to d...
Jul. 7, 2015 03:30 PM EDT Reads: 2,347
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect t...
Jul. 7, 2015 03:30 PM EDT Reads: 1,961
[slides] Workloads and Public Cloud at @CloudExpo By @utollwi | @ProfitBricksUSA #DevOps #Containers #Microservices
Public Cloud IaaS started its life in the developer and startup communities and has grown rapidly to a $20B+ industry, but it still pales in comparison to how much is spent worldwide on IT: $3.6 trillion. In fact, there are 8.6 million data centers worldwide, the reality is many small and medium sized business have server closets and colocation footprints filled with servers and storage gear. While on-premise environment virtualization may have peaked at 75%, the Public Cloud has lagged in adop...
Jul. 7, 2015 03:00 PM EDT Reads: 2,739
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development...
Jul. 7, 2015 02:45 PM EDT Reads: 2,110
Agile, which started in the development organization, has gradually expanded into other areas downstream - namely IT and Operations. Teams – then teams of teams – have streamlined processes, improved feedback loops and driven a much faster pace into IT departments which have had profound effects on the entire organization. In his session at DevOps Summit, Anders Wallgren, Chief Technology Officer of Electric Cloud, will discuss how DevOps and Continuous Delivery have emerged to help connect dev...
Jul. 7, 2015 02:30 PM EDT Reads: 2,199
One of the hottest new terms in the world of enterprise computing is the microservice. Starting with the seminal 2014 article by James Lewis and Martin Fowler of ThoughtWorks, microservices have taken on a life of their own – and as with any other overhyped term, they have generated their fair share of confusion as well. Perhaps the best definition of microservices comes from Janakiram MSV, Principal at Janakiram & Associates. “Microservices are fine-grained units of execution. They are designe...
Jul. 7, 2015 02:30 PM EDT Reads: 1,452
In their general session at 16th Cloud Expo, Michael Piccininni, Global Account Manager - Cloud SP at EMC Corporation, and Mike Dietze, Regional Director at Windstream Hosted Solutions, reviewed next generation cloud services, including the Windstream-EMC Tier Storage solutions, and discussed how to increase efficiencies, improve service delivery and enhance corporate cloud solution development. Michael Piccininni is Global Account Manager – Cloud SP at EMC Corporation. He has been engaged in t...
Jul. 7, 2015 02:15 PM EDT Reads: 2,482
In the last blog we started the conversation on our findings from @Cloud Expo 2015 and @ThingsExpo 2015 as the industry came together to explore the impact of Cloud and Internet of Things (IoT) on business models as we know them. While often the focus of IoT are consumer services and the sometimes over-simplification of what constitutes an IoT company or service, one area there is no disputing is the significant advancement in the Industrial Internet (a term made popular by GE). Ongoing improvem...
Jul. 7, 2015 01:45 PM EDT Reads: 2,553
Announcing @AlertLogic “Bronze Sponsor” of @CloudExpo & @DevOpsSummit | #IoT #DevOps #Docker #Microservices
SYS-CON Events announced today that Alert Logic, the leading provider of Security-as-a-Service solutions for the cloud, has been named “Bronze Sponsor” of SYS-CON's 17th International Cloud Expo® and DevOps Summit 2015 Silicon Valley, which will take place November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Alert Logic provides Security-as-a-Service for on-premises, cloud, and hybrid IT infrastructures, delivering deep security insight and continuous protection for cust...
Jul. 7, 2015 01:45 PM EDT Reads: 2,464
One of the charter responsibilities of DevOps (because it's a charter responsibility of ops) is measuring and monitoring applications once they're in production. That means both performance and availability. Which means a lot more than folks might initially think because generally speaking what you measure and monitor is a bit different depending on whether you're looking at performance or availability*.
Jul. 7, 2015 01:45 PM EDT Reads: 1,310
The cloud has transformed how we think about software quality. Instead of preventing failures, we must focus on automatic recovery from failure. In other words, resilience trumps traditional quality measures. Continuous delivery models further squeeze traditional notions of quality. Remember the venerable project management Iron Triangle? Among time, scope, and cost, you can only fix two or quality will suffer. Only in today's DevOps world, continuous testing, integration, and deployment upend...
Jul. 7, 2015 01:30 PM EDT Reads: 2,730