|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.
The goal of any tech business worth its salt is to provide the best product or service to its clients in the most efficient and cost-effective way possible. This is just as true in the development of software products as it is in other product design services. Microservices, an app architecture style that leans mostly on independent, self-contained programs, are quickly becoming the new norm, so to speak. With this change comes a declining reliance on older SOAs like COBRA, a push toward more s...
Apr. 30, 2016 06:30 PM EDT Reads: 1,287
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus inter...
Apr. 30, 2016 04:45 PM EDT Reads: 977
This is not a small hotel event. It is also not a big vendor party where politicians and entertainers are more important than real content. This is Cloud Expo, the world's longest-running conference and exhibition focused on Cloud Computing and all that it entails. If you want serious presentations and valuable insight about Cloud Computing for three straight days, then register now for Cloud Expo.
Apr. 30, 2016 02:30 PM EDT Reads: 1,698
SYS-CON Events announced today that Stratoscale, the software company developing the next generation data center operating system, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Stratoscale is revolutionizing the data center with a zero-to-cloud-in-minutes solution. With Stratoscale’s hardware-agnostic, Software Defined Data Center (SDDC) solution to store everything, run anything and scale everywhere...
Apr. 30, 2016 01:15 PM EDT Reads: 1,519
Digital means customer preferences and behavior are driving enterprise technology decisions to be sure, but let’s not forget our employees. After all, when we say customer, we mean customer writ large, including partners, supply chain participants, and yes, those salaried denizens whose daily labor forms the cornerstone of the enterprise. While your customers bask in the warm rays of your digital efforts, are your employees toiling away in the dark recesses of your enterprise, pecking data into...
Apr. 30, 2016 12:00 PM EDT Reads: 957
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Apr. 30, 2016 12:00 PM EDT Reads: 2,275
You deployed your app with the Bluemix PaaS and it's gaining some serious traction, so it's time to make some tweaks. Did you design your application in a way that it can scale in the cloud? Were you even thinking about the cloud when you built the app? If not, chances are your app is going to break. Check out this webcast to learn various techniques for designing applications that will scale successfully in Bluemix, for the confidence you need to take your apps to the next level and beyond.
Apr. 30, 2016 11:30 AM EDT Reads: 1,459
I had the opportunity to catch up with Chris Corriere - DevOps Engineer at AutoTrader - to talk about his experiences in the realm of Rugged DevOps. We discussed automation, culture and collaboration, and which thought leaders he is following. Chris Corriere: Hey, I'm Chris Corriere. I'm a DevOps Engineer AutoTrader. Derek Weeks: Today we're going to talk about Rugged DevOps. It's a subject that's gaining a lot of traction in the community but not a lot of people are really familiar with wh...
Apr. 30, 2016 09:45 AM EDT Reads: 1,566
Wow, if you ever wanted to learn about Rugged DevOps (some call it DevSecOps), sit down for a spell with Shannon Lietz, Ian Allison and Scott Kennedy from Intuit. We discussed a number of important topics including internal war games, culture hacking, gamification of Rugged DevOps and starting as a small team. There are 100 gold nuggets in this conversation for novices and experts alike.
Apr. 30, 2016 09:15 AM EDT Reads: 494
In 2006, Martin Fowler posted his now famous essay on Continuous Integration. Looking back, what seemed revolutionary, radical or just plain crazy is now common, pedestrian and "just what you do." I love it. Back then, building and releasing software was a real pain. Integration was something you did at the end, after code complete, and we didn't know how long it would take. Some people may recall how we, as an industry, spent a massive amount of time integrating code from one team with another...
Apr. 30, 2016 09:00 AM EDT Reads: 744
SYS-CON Events announced today that DatacenterDynamics has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY. DatacenterDynamics is a brand of DCD Group, a global B2B media and publishing company that develops products to help senior professionals in the world's most ICT dependent organizations make risk-based infrastructure and capacity decisions.
Apr. 30, 2016 06:00 AM EDT Reads: 2,463
With DevOps becoming more well-known and established practice in nearly every industry that delivers software, it is important to continually reassess its efficacy. This week’s top 10 includes a discussion on how the quick uptake of DevOps adoption in the enterprise has posed some serious challenges. Additionally, organizations who have taken the DevOps plunge must find ways to find, hire and keep their DevOps talent in order to keep the machine running smoothly.
Apr. 30, 2016 04:45 AM EDT Reads: 1,385
Call it DevOps or not, if you are concerned about releasing more code faster and at a higher quality, the resulting software delivery chain and process will look and smell like DevOps. But for existing development teams, no matter what the velocity objective is, getting from here to there is not something that can be done without a plan. Moving your release cadence from months to weeks is not just about learning Agile practices and getting some automation tools. It involves people, tooling and ...
Apr. 30, 2016 04:00 AM EDT Reads: 1,484
Between the mockups and specs produced by analysts, and resulting applications built by developers, there exists a gulf where projects fail, costs spiral, and applications disappoint. Methodologies like Agile attempt to address this with intensified communication, with partial success but many limitations. In his session at 18th Cloud Expo, Charles Kendrick, CTO & Chief Architect at Isomorphic Software, will present a revolutionary model enabled by new technologies. Learn how business and devel...
Apr. 30, 2016 04:00 AM EDT Reads: 1,728
The notion of customer journeys, of course, are central to the digital marketer’s playbook. Clearly, enterprises should focus their digital efforts on such journeys, as they represent customer interactions over time. But making customer journeys the centerpiece of the enterprise architecture, however, leaves more questions than answers. The challenge arises when EAs consider the context of the customer journey in the overall architecture as well as the architectural elements that make up each...
Apr. 30, 2016 02:45 AM EDT Reads: 1,944
Much of the discussion around cloud DevOps focuses on the speed with which companies need to get new code into production. This focus is important – because in an increasingly digital marketplace, new code enables new value propositions. New code is also often essential for maintaining competitive parity with market innovators. But new code doesn’t just have to deliver the functionality the business requires. It also has to behave well because the behavior of code in the cloud affects performan...
Apr. 30, 2016 02:30 AM EDT Reads: 1,345
APIs have taken the world by storm in recent years. The use of APIs has gone beyond just traditional "software" companies, to companies and organizations across industries using APIs to share information and power their applications. For some organizations, APIs are the biggest revenue drivers. For example, Salesforce generates nearly 50% of annual revenue through APIs. In other cases, APIs can increase a business's footprint and initiate collaboration. Netflix, for example, reported over 5 bi...
Apr. 29, 2016 09:30 PM EDT Reads: 2,558
As the software delivery industry continues to evolve and mature, the challenge of managing the growing list of the tools and processes becomes more daunting every day. Today, Application Lifecycle Management (ALM) platforms are proving most valuable by providing the governance, management and coordination for every stage of development, deployment and release. Recently, I spoke with Madison Moore at SD Times about the changing market and where ALM is headed.
Apr. 29, 2016 09:15 PM EDT Reads: 1,436
If there is anything we have learned by now, is that every business paves their own unique path for releasing software- every pipeline, implementation and practices are a bit different, and DevOps comes in all shapes and sizes. Software delivery practices are often comprised of set of several complementing (or even competing) methodologies – such as leveraging Agile, DevOps and even a mix of ITIL, to create the combination that’s most suitable for your organization and that maximize your busines...
Apr. 29, 2016 08:30 PM EDT Reads: 1,765
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
Apr. 29, 2016 07:45 PM EDT Reads: 2,034