By Ann Neuer 

August 9, 2012 | Many fresh technologies exhibited at the recent 2012 Drug Information Association (DIA) Annual Meeting appear poised to bring measurable efficiencies to the clinical trials space. This report – the second in a two-part series from DIA 2012 (see part I of the DIA blog) -- features companies that embody the meeting’s key theme, Collaborate to Innovate. Companies including NextDocs Corporation, Sitrof Technologies with its electronic trial master file (eTMF) solutions, and Comprehend Systems with its innovative approach to clinical trial analytics, stood out as exciting offerings aimed at improving data quality while helping clinical trials adhere to rigid timelines.  

eTMF Makes a Showy Entrance 

If DIA is any measure of industry trends, the eTMF is an emerging player in the clinical trial space. Notable was the release of version 2.0 of the DIA Trial Master File Reference Model; results of a new survey documenting an ongoing transition from paper TMFs to eTMFs; and greater visibility of vendors displaying their eTMF wares.    

“The eTMF is hot now because pharmaceutical companies are seeking cost efficient ways to collect and support the integrity and quality of the data from sites all over the world. Also, some of the larger pharmaceutical companies have been approached by regulatory agencies regarding the quality of their paper documentation, so everyone is taking heed from these warnings,” says Sharon Ames, Enterprise Program Director at NextDocs Corporation, an eTMF provider. 

The eTMF is the electronic version of the trial master file, which contains essential documents that enable the evaluation of the conduct of a clinical trial and the quality of the data produced (eCliniqua COMMENT: 2012 Survey Demonstrates Growth in eTMF and Impact of Standards). Because a global clinical trial with dozens of investigative sites can produce massive volumes of these documents, all of which must be collected and accounted for at the end of a trial, and then stored in accordance with regulatory guidelines, processes are needed to facilitate this major undertaking.  

With electronic options available, paper methods are increasingly viewed as too time consuming, burdensome, and costly. And they are rarely in audit-ready format. By comparison, eTMFs can be web-based or exist in the cloud, making access fast and easy and subject to authorized workflow. And importantly, the documents are always audit-ready.  

Despite the compelling case for the eTMF and 2012 survey data from an industry coalition subgroup showing a 12 percentage point increase since 2010 in the number of respondents currently planning, building or evaluating eTMF, some serious issues remain. Security of the cloud is a major concern and in the US, the Food and Drug Administration (FDA) is yet to issue an eTMF guidance. Nevertheless, there is a 2007 guidance that suggests there should be sufficient backup and recovery procedures when electronic formats are the only ones used to create and preserve electronic records. In the absence of an eTMF guidance, the issues of backup and recovery must still be addressed as the eTMF gains a foothold.  

Bryan Reynolds

“Security is one of the biggest fear factors in the cloud,” says Bryan Reynolds, co-founder and managing partner of Sitrof Technologies, a life sciences consulting and technology provider. “To address this concern, our eTMF solution will be available in a secure, validated private cloud, which will offer a level of encryption far greater than what is available with paper.” Sitrof’s recently launched alpha version of the eTMF solution will be followed by the fully functioning beta version, scheduled for late summer 2012. The company’s first customer release, which is based on the DIA TMF Reference Model, is slated for launch in late fourth quarter. 

NextDocs has been offering an eTMF since 2010. Its web-based product is also aligned with the DIA TMF Reference Model and is available for on-premises deployment or in the NextDocs Compliance Cloud. And the product is garnering attention. According to Ames, “Our salespeople are telling me that interest in our clinical products, including the eTMF, is four-to-one over our other solutions.” Matt Walz, Chief Technology Officer at NextDocs, says the clinical suite, including the eTMF, grew topline revenues 43% in 2011 over 2010 and may grow even more in 2012. The company is helping many clients with transitions from paper to eTMF. Generally, transitions take place either at the beginning of a small study or early on in a longer study. “If you are five years into a nine year study, you probably aren’t going to transition to the eTMF, but if it’s only year two, it’s something to consider,” explains Ames. 

Data Analytics Made Easy 

Conventional wisdom has recently held that electronic data capture (EDC), clinical trial management systems (CTMS) and other solutions need to be integrated if clinical trial data are to flow efficiently and in real time. But Rick Morrison, CEO of Comprehend Systems, says there is a simpler, more value-driven approach. 

Rick Morrison

“Trying to throw out the old systems and replace them with a single integrated system doesn’t really work. There are too many quirks between studies and between systems. At Comprehend, we are offering visualization and analytics of clinical trial data regardless of where they reside, using a simple out-the-box solution that works with an iPad, email, or any standard web browser,” Morrison comments. 

Comprehend’s approach is to focus on helping clinical trial stakeholders quickly answer questions that are essential for their work. A monitor, for example, will want to know what’s happening at his or her investigative sites. The study manager wants to see the progress of the entire study and identify and resolve bottlenecks. The executive is seeking the status of all studies across the portfolio.    

According to Morrison, the company’s product, Comprehend Clinical, can answer these questions by allowing users to create customized interactive dashboards that extend across all of the systems that house data. The dashboards enable ad hoc reporting of real time analytics using simple drag and drop methods. For example, charts can be created by selecting what should be on the X- and Y- axes, and then dragging and dropping that information. With these analytics, the user can see a graphical representation of information and then drill down to a patient’s profile or the number of adverse events across specific study populations. No programming or IT investment is required. 

Comprehend, which is Part 11 compliant, works by sitting in the middle of the various clinical trial systems and extracting information from the source data systems. With data delivered from the cloud, this system can support commonly used EDC solutions such as Medidata Rave and Oracle Clinical, and embed in popular document management systems in a way that is invisible to the user.    

“The key word is frictionless,” says Morrison. “If there is any friction that prevents people from asking these questions or if people have to rely on programmers, they aren’t going to be able to do it. Our number one challenge was to make Comprehend Clinical really easy so anyone to do this.”