|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.
"In the IoT space we are helping customers, mostly enterprises and industry verticals where time-to-value is critical, and we help them with the ability to do faster insights and actions using our platform so they can transform their business operations," explained Venkat Eswara, VP of Marketing at Vitria, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 6, 2015 04:01 PM EDT Reads: 128
SYS-CON Events announced today that WHOA.com, an ISO 27001 Certified secure cloud computing company, participated as “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which took place June 9-11, 2015, at the Javits Center in New York City, NY. WHOA.com is a leader in next-generation, ISO 27001 Certified secure cloud solutions. WHOA.com offers a comprehensive portfolio of best-in-class cloud services for business including Infrastructure as a Service (IaaS), Secure Cloud Desktop, Cloud Storage, Disaster Recovery, Integrated Applications and Security.
Jul. 6, 2015 02:45 PM EDT Reads: 845
SYS-CON Events announced today that Intelligent Systems Services will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Established in 1994, Intelligent Systems Services Inc. is located near Washington, DC, with representatives and partners nationwide. ISS’s well-established track record is based on the continuous pursuit of excellence in designing, implementing and supporting nationwide clients’ mission-critical systems. ISS has completed many successful projects in Healthcare, Commercial, Manu...
Jul. 6, 2015 02:15 PM EDT Reads: 993
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of profound change in the industry.
Jul. 6, 2015 02:15 PM EDT Reads: 1,830
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, 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 Internet of Things (IoT) is the most profound change in personal an...
Jul. 6, 2015 02:00 PM EDT Reads: 1,243
SYS-CON Events announced today that kintone has been named “Bronze Sponsor” of 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. kintone promotes cloud-based workgroup productivity, transparency and profitability with a seamless collaboration space, build your own business application (BYOA) platform, and workflow automation system.
Jul. 6, 2015 01:45 PM EDT Reads: 2,114
SYS-CON Events announced today that SoftLayer, an IBM company, has been named “Gold Sponsor” of SYS-CON's 17th International Cloud Expo®, which will take place November 3–5, 2015 at the Santa Clara Convention Center in Santa Clara, CA. SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer’s modular architecture, full-featured API, and sophisticated automation pro...
Jul. 6, 2015 01:15 PM EDT Reads: 2,191
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 their organization.
Jul. 6, 2015 01:15 PM EDT Reads: 1,802
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 are using some form of XaaS – software, platform, and infrastructure as a service.
Jul. 6, 2015 01:00 PM EDT Reads: 1,707
The enterprise market will drive IoT device adoption over the next five years. In his session at @ThingsExpo, John Greenough, an analyst at BI Intelligence, division of Business Insider, analyzed how companies will adopt IoT products and the associated cost of adopting those products. John Greenough is the lead analyst covering the Internet of Things for BI Intelligence- Business Insider’s paid research service. Numerous IoT companies have cited his analysis of the IoT. Prior to joining BI Intelligence, he worked analyzing bank technology for Corporate Insight and The Clearing House Payment...
Jul. 6, 2015 01:00 PM EDT Reads: 791
SYS-CON Events announced today that CommVault has been named “Bronze Sponsor” of 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. A singular vision – a belief in a better way to address current and future data management needs – guides CommVault in the development of Singular Information Management® solutions for high-performance data protection, universal availability and simplified management of data on complex storage networks. CommVault's exclusive single-platform architecture gives companies unp...
Jul. 6, 2015 12:15 PM EDT Reads: 2,077
"ciqada is a combined platform of hardware modules and server products that lets people take their existing devices or new devices and lets them be accessible over the Internet for their users," noted Geoff Engelstein of ciqada, a division of Mars International, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 6, 2015 11:45 AM EDT Reads: 650
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists peeled 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 fillin...
Jul. 6, 2015 11:45 AM EDT Reads: 2,573
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!
Jul. 6, 2015 11:30 AM EDT Reads: 1,705
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Among the proven benefits, DevOps is corr...
Jul. 6, 2015 11:15 AM EDT Reads: 1,736
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, discussed 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 IoT ...
Jul. 6, 2015 11:00 AM EDT Reads: 2,530
SYS-CON Events announced today that Secure Infrastructure & Services 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. Secure Infrastructure & Services (SIAS) is a managed services provider of cloud computing solutions for the IBM Power Systems market. The company helps mid-market firms built on IBM hardware platforms to deploy new levels of reliable and cost-effective computing and high availability solutions, leveraging the cloud and the benefits of Infrastructure-as-a-Service (IaaS...
Jul. 6, 2015 10:00 AM EDT Reads: 1,818
The basic integration architecture, as defined by ESBs, hasn’t changed for more than a decade. Most cloud integration providers still rely on an ESB architecture and their proprietary connectors. As a result, enterprise integration projects suffer from constraints of availability and reliability of these connectors that are not re-usable across other integration vendors. However, the rapid adoption of APIs and almost ubiquitous availability of APIs amongst most SaaS and Cloud applications are rapidly redefining traditional integration approaches and their reliance on proprietary connectors. ...
Jul. 6, 2015 09:45 AM EDT Reads: 1,456
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, will explore the IoT cloud-based platform technologies driving this change including privacy controls, data transparency and integration of real time context wi...
Jul. 6, 2015 09:45 AM EDT Reads: 1,789
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, 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. 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.
Jul. 6, 2015 09:15 AM EDT Reads: 2,129