By Cindy Dubin
The massive spending of big pharma in the 1980s and 1990s took a big hit with the recession. Outsourcing and downsizing became the life sciences norm, and internal IT departments were among the first to go. For many organizations, this move particularly hurt the laboratory and its reliance on IT to help maintain in-house laboratory information management systems (LIMS).
Historically, LIMS have been delivered using the outright purchase model, with labs purchasing their own hardware and software, and then configuring the LIMS to meet their workflow requirements — a timely and cost-prohibitive venture for labs. The success of Salesforce.com — an online Software-as-a-Service (SaaS) company distributing business software in which access to the software is purchased by subscription and hosted off-site — has end users and suppliers reevaluating software acquisition methods. “Small to midsize laboratories may find the Internet-hosted model a more affordable option for LIMS,” says senior analyst Paula Hollywood, the principal author of ARC’s market report, Laboratory Information Management Systems Worldwide Outlook.
SaaS is a type of cloud computing on a Web 2.0 platform, which makes resources available via the Internet on a subscription basis. Web 2.0 is a “souped up” or dynamic version of Web 1.0, which tends to be more static in nature. Web 2.0 is what allows information sharing among a group of users on the Internet. The characteristics of Web 2.0 include rich user experience, user participation, dynamic content, and scalability.
Conducting business over the Web is a much less costly option for life sciences labs in today’s economy. A traditional in-house, client/server-based LIMS can cost a pharmaceutical company anywhere from $250,000 to several million dollars in start-up costs, consulting, customization, licensing fees, and ongoing maintenance. “This is out of reach for many small- and medium-sized labs,” says Thomas Kent, president and CEO of Sciformatix, a company whose LIMS is aimed at small to midsize laboratories. “As a result, more than 80% of scientific labs still rely solely on informal tools for managing samples and other important information.” These informal tools do not scale well as growth ensues, make it challenging to share information with other people, and sometimes make it difficult to adjust to new processes and sample types. Further, the informal tools generally lack features that can efficiently track and determine the precise location of samples.
60% PROCESS IMPROVEMENT
Finding a better way to keep track of information about its drug compounds and biological samples is what drove one pharmaceutical laboratory to consider a SaaS-based LIMS. The lab performs stability and release testing on drug compounds, including accelerated stability testing, long-term stability testing, comparative stability testing, and forced degradation studies. The lab also performs experimental work with biological samples, such as DNA and RNA. Excel spreadsheets and paper-based lab notebooks were the main sources for tracking data. “Much of our information was scattered among different sources, and we didn’t have a way to consolidate the information,” says the lab director. “A SaaS LIMS was very affordable, with a minimal up-front investment of a few thousand dollars and manageable monthly subscription costs of just a few hundred dollars. Previously, when we looked at the idea of purchasing a licensed LIMS solution, we found that it would be too expensive to purchase, customize, and pay the annual maintenance fees, along with the expenses of purchasing and managing the computers on which it would run. We also tried to create our own LIMS solution, but we didn’t really have the expertise, and it was taking too long and costing too much to develop a workable solution.”
Since implementing the Sciformatix SciLIMS just a few months ago, the lab director says operations are significantly more productive. Processes have been streamlined, reducing effort by 50% to 60%, saving hours of work on a daily and weekly basis. In addition, information is much easier to access for all eight users, reducing the time that used to be spent locating spreadsheets, generating reports, and finding samples. “One of the greatest benefits was the short amount of time it took to get SciLIMS implemented in our lab,” he says. “Within a few days, we were up and running, capturing data and gaining better insight into the activities in our lab.”
MAKING THE SWITCH TO SAAS
Giving more labs better insight into their operations is one of the reasons why Thermo Fisher Scientific launched its SaaS-based LIMS-on-Demand this past March. Thermo Fisher, which offers a traditional client/server LIMS, realized quickly that not only was IT spending drying up because of the recession, but that a significant part of the market could be served with an on-demand solution that could deliver the functionality of a client/server LIMS at a more affordable cost. For just under $10,000, a lab can obtain three LIMS-on-Demand licenses and online consultation for six months. At the end of the six months, the decision can be made to simply walk away or begin a monthly subscription for $375 per user per month. According to Kim Shah, director of marketing and business development for Thermo, the SaaS-based LIMS offers full functionality to even the smallest of labs.
Consider, for example, the 20-person spinal cord research lab at the University of Miami. The lab, under direction of Dr. Vance Lemmon, identifies compounds and genes that promote cell regeneration. “The screening world is complicated, and we were struggling to understand how and why certain experiments of ours were failing or succeeding,” explains Dr. Lemmon, a professor and endowed chair at the university. Given the volume of the work and a reliance on inefficient paper-based methods, the decision was made two years ago to purchase Thermo Scientific’s Nautilus LIMS. “We quickly discovered that the cost of having the university’s IT department maintain the servers and install updates was just too costly.”
When Thermo Fisher introduced LIMS-on-Demand, Dr. Lemmon agreed to beta test the system. Since implementing in February 2010, Dr. Lemmon says making the switch from a client/server environment to a Web system has been seamless. “We can keep track of the reagents we use in our experiments down to the bottle level so that we can identify which agents cause us problems and which do not. We got away from our dependence on the PC platform, which the Nautilus required us to use, to an open platform that includes Mac. We can also access our database from anywhere, and we’ve seen an increase in our productivity time because we spend less time configuring workflows,” he says.
HAVING FUD WITH LIMS
Despite the advantages, lab directors may have some fear, uncertainty, and doubt (FUD) about SaaS-based LIMS. Enhancing compliance with regulatory guidelines is a major impetus for acquiring and implementing an internal LIMS, according to the ARC report. Evolving regulations require improved documentation of laboratory tests and an enhanced ability to share test results with other departments and third parties in real time. One of the crucial functions of LIMS is the ability to trace each event in the life cycle of a sample, which is essential in protecting laboratory results, tracking, and for regulatory compliance.
While some believe the firewall protection an in-house LIMS might offer facilitates validation and regulatory compliance, SaaS pros point out that the Web-based delivery model does not preclude the ability to attain GLP validation or other types of GxP validations. Alan Vaughan, content developer for LABLynx, says: “We have performed successful CAP [College of American Pathologists] validation assistance and 21 CFR part 11 validation and support good automated laboratory and good automated manufacturing practice [GALP, GAMP] regulations.”
Regulations are no stranger to Mary Barry. She is currently the vice president of operations for a clinical laboratory improvement amendments (CLIA)-approved start-up, which requires the lab to meet quality standards for all laboratory testing to ensure accuracy and reliability. Before joining this company, Barry worked for a similar CLIA start-up lab that was tight on funds, but wanted to use a LIMS to help launch market-changing products, she explains. “Because a traditional LIMS was too cost-prohibitive for us, I chose the LABLynx webLIMS as a viable alternative because it was auditable and could be installed in a regulatory environment,” Barry says. While she currently uses a traditional LIMS at her new company for clinical trials, she is seriously considering moving to a SaaS environment once again because of her confidence in its security and regulatory compliance.
Despite the possible security and regulatory compliance concerns that some lab managers might have about SaaS, the worldwide market for LIMS is expected to grow at a compounded annual growth rate of 2.9% over the next five years due in large part to SaaS, states the ARC report, and is expected to reach sales of $454 million in 2013. “There have been ongoing debates ever since SaaS hit the scene, and when people really get down to analyzing SaaS, they understand that this is merely a different delivery method and doesn’t distract from the capabilities that an on-premise solution might provide,” says Kent.