PALO ALTO, CALIF. – May 9, 2013 – Comprehend Systems was named one of only five Gartner “Cool Vendors in Life Sciences, 2013″ for its ability to offer clinical research sponsors unparalleled access to clinical and operational data insights. Compiled by leading Gartner analysts including Steven Lefebure, Dale Hagemeyer and Michael Shanler, the report features vendors bringing unique solutions to the life science industry with leading tools for aggregating and delivering value from data.

Since 2010, Comprehend Systems has been replacing the clunky and expensive data warehouses, ETL tools, BI tools and teams of programmers traditionally required for sponsors and contract research organizations (CROs) to make sense of their clinical data. With Comprehend Clinical™, researchers can quickly start extracting real value from their previous investments in electronic data capture (EDC), clinical data management (CTMS) and other systems by providing the real-time data insights and dashboards they need to make critical decisions about their trials.

“Gartner understands that one of the biggest challenges facing life sciences leaders today is quickly achieving performance improvements based on the volumes of existing data that are currently siloed away in various systems,” said Rick Morrison, CEO of Comprehend Systems. “We’re solving this expensive and time-consuming problem for sponsors and CROs with a solution that enables true clinical data insights through the cloud – without involving programmers, large procurement cycles or slow integration processes.”

Comprehend most recently announced a first-of-its-kind approach to accessing data insights with the launch of the online signup of Comprehend Clinical. By simply visiting the Comprehend website and creating an account, executives, data managers, study managers, clinical operations, biostatisticians, monitors and others can quickly start gaining critical insights across all of their clinical and operational data. Sponsors and CROs can begin using Comprehend Clinical against a single study within days, for as little as $1250 per month. They can also easily scale up to use additional features of Comprehend, like full cross-trial and cross-system, or support for other commercial or proprietary data systems.

To access “Gartner’s Cool Vendors in Life Sciences, 2013″ report, visit http://www.gartner.com/id=2470915.

Tweet this:  .@Comprehend named @Gartner_inc “Cool Vendor” for ability to offer simultaneous #clinical and operational insights http://bit.ly/13j95pI

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers cloud-based clinical data insights tools that improve the way clinical researchers access, understand, explore and analyze data. Designed specifically for life sciences, Comprehend Clinical ™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

Contact

Susan McCarron
617.986.5767
susan@comprehend.com

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PALO ALTO, CALIF. – May 1, 2013 – Comprehend Systems today announced a first-of-its-kind approach to accessing data insights with the launch of the online signup of Comprehend Clinical™. Now, by simply visiting the Comprehend website and creating an account, executives, data managers, study managers, clinical operations, biostatisticians, monitors and others can almost immediately gain critical insights across all of their clinical and operational data.

Over the past decade, sponsors and contract research organizations (CROs) have made significant investments in a dizzying array of EDC, CTMS, and other electronic data collection systems – with the promise of helping trials run cheaper and more efficiently. However, the promised value hasn’t been realized, and instead sponsors and CROs have been forced to piece together mishmashes of clunky and expensive data warehouses, ETL tools, BI tools, teams of programmers, and more, often to no avail. These systems are extremely expensive, time-consuming to build, and do not deliver the promised real-time insights quickly enough to make critical decisions.

“Due to the sheer number of data collection systems available, mergers and acquisitions and the widespread lack of standardization, it’s simply not possible for any one data collection vendor to fully ‘own’ all the clinical data,” said Rick Morrison, CEO of Comprehend Systems. “Sponsors can’t afford to continue investing in cumbersome integration implementations, only to be disappointed with the outcome. Comprehend Clinical addresses these pain points by delivering on the promise of true clinical data insights through the cloud. Available in days, without the need to wait on programmers, large procurement cycles, or slow integration processes.”

Sponsors and CROs can begin using Comprehend Clinical against a single study within days, all for a reasonable monthly fee. To get started, simply visit the Comprehend website, create an account, and provide connection details to existing EDC or other data systems through the cloud. This is all that’s required to start using Comprehend Clinical™ to gain clinical and operational insights almost immediately – without involving IT departments, capital expenditures, software developers or long procurement processes.

Any sponsor using Medidata Rave, SDTM datasets, Medrio, Oracle Clinical, Oracle Inform and other systems can register for Comprehend Clinical on the site. They can then download and sign an NDA and start viewing their clinical data in a matter of days. There are no long upfront contracts required, sponsors can start on a month-by-month basis. Sponsors and CROs can also easily scale up to use additional features of Comprehend, like full cross-trial and cross-system, or support for other commercial or proprietary data systems.

Tweet this:  A #pharma industry first: self-service access to both #clinical and operational #data insights from @comprehend http://bit.ly/12RVTXG

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers cloud-based clinical data insights tools that improve the way clinical researchers access, understand, explore and analyze data. Designed specifically for life sciences, Comprehend Clinical ™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

Contact
Susan McCarron
617.986.5767
susan@comprehend.com

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PALO ALTO, CALIF. – February 12, 2013 – With an increasing shift towards risk-based monitoring and the adoption of new cloud-based clinical trial technologies, Comprehend Systems CEO Rick Morrison will share his expertise and insights on the clinical research analytics landscape at two key industry events next month:

DIA Annual EuroMeeting

• March 4-6, Amsterdam, The Netherlands
• Presentation: “Sites Unseen: Game plan for sponsors moving to risk-based monitoring”
• Date & Time: March 5, 9:00 a.m. CET

Morrison will present as part of the “New Approaches for Monitoring” track at this year’s EuroMeeting, where he will share his perspective on the essentials of risk-based monitoring in clinical trials and strategies for reducing site monitoring costs by more than 50 percent. Morrison will detail factors sponsors should consider to successfully design and execute a more targeted, risk-based monitoring strategy to cut costs and improve efficiencies across the board. He will also highlight how new technologies make this shift possible, enabling sponsors to access data from multiple systems and perform complex analytics that directly address the challenges of accurate assessment and pinpointing which patients and sites to monitor.

ACDM Annual Conference 2013

• March 17-19, Berkshire, UK
• Presentation: “Clinical IT Innovation: Driving the Evolution of Data Management”
• Date & Time: March 19, 11:30 a.m. GMT

Morrison will lead a technology session on clinical IT innovation at this year’s ACDM event, specifically sharing his experiences on how access to the right data, reports and analytics supports data managers’ ability to make decisions easier and faster. Morrison will describe how key technologies will impact clinical data management and drive the evolution of data management into an even more strategic and critical role. By eliminating the need to rely on programmers, clinical IT will transform the role of data managers.

Tweet this: .@Comprehend CEO Rick Morrison to discuss risk based monitoring & #clinical #IT at #EuroMeeting 2013 & #acdmconf2013 http://bit.ly/V0TkTi

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers clinical data visualization, analytics and reporting software that improves the way clinical researchers access, understand, explore and analyze data. Designed specifically for clinical researchers, Comprehend Clinical ™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

Contact

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PALO ALTO, CALIF. – November 15, 2012 – Rick Morrison, CEO and co-founder of Comprehend Systems will join health IT experts from leading companies including Aetna, Castlight Health and Becton Dickinson in a one-day health information technology conference sponsored by the Life Science Angel Network (L SAN).

Healthcare Information Technology: Change, Outlook and Opportunity

November 20, 2012, New York, NY

Presentation: “Regulators and Regulations”

Morrison will offer attendees of his expertise on navigating the regulatory environment alongside other top industry experts including Bakul Patel, a policy advisor at the FDA, and fellow health IT CEOs.

“With this event, the Life Science Angel Network is bringing together an impressive group of leaders and influencers to discuss many of the most pressing issues facing entrepreneurs in the health technology space.” said Rick Morrison, CEO and co-founder of Comprehend Systems, “I’m excited to share Comprehend’s experience working closely with pharma, biotech and CRO organizations as we continue to tackle challenges in the ever-changing regulatory landscape.”

Tweet this: .@Comprehend’s CEO @morrisor talks #healthIT regulations at @LSANNYC event on industry innovation http://bit.ly/W9HyA8

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers clinical data visualization, analytics and reporting software that improves the way clinical researchers access, understand, explore and analyze data. Designed specifically for clinical researchers, Comprehend Clinical ™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

Contact

Susan McCarron

617.986.5767

susan_mccarron@lpp.com

PALO ALTO, CALIF. – October 16, 2012 – With increasing number of sponsors and CROs looking to Comprehend Systems for cloud-based data analytics, visualizations and reporting, the company has named Rich Enz as vice president of quality assurance to support the development of pioneering cloud-based analytics tools. In addition to key industry contributions including the design of an award-winning clinical data management system, enterprise portal and CANDA system used by the FDA, Enz brings more than 35 years of experience driving research and development of large-scale clinical trials IT systems at companies like Covance, Inc., Integrated Clinical Systems and Teva Pharmaceuticals. Enz was also responsible for creating and validating one of the industry’s first clinical data management systems, Sherlock, while at Covance.

“Comprehend’s approach to clinical data analytics is driving change in the industry in an entirely new way, at a time when it has become extremely critical for researchers at pharmaceutical and biotechnology companies to be able to quickly gain insights into their data in real-time,” said Enz. “As more and more research sponsors become comfortable with the security and performance of the cloud, I’m excited to join a company that’s committed to making cumbersome, time-consuming and programmer-heavy clinical trial software deployments a thing of the past.”

Prior to joining Comprehend, Enz served as associate director of application programming environment at Teva’s Global Branded Products division, where he was responsible for SAS administration and maintaining a validated SAS programming environment. Previously, Enz developed software at Integrated Clinical Systems. Enz also spent 15 years at contract research organization Covance, where, as senior director of clinical information technology, he provided technical oversight and architectural guidance to clinical IT staff and project teams. He also developed an international distributed database system at CIBA-Geigy, which is now part of Novartis.

“Along with years’ worth of experience as a leading software developer in the clinical research space, Rich shares our vision of continuing to revolutionize the way clinical trials are conducted,” said Rick Morrison, CEO of Comprehend Systems. “He will play a key role in supporting our leadership team and future product development as we continue to see increased traction with our cloud-based solution.”

Tweet this: Pharma technology industry veteran Rich Enz joins @Comprehend Systems as VP of Quality Assurance http://bit.ly/WqC07j

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers clinical data visualization, analytics and reporting software that improves the way clinical researchers access, understand, explore and analyze data. Designed specifically for clinical researchers, Comprehend Clinical™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

Contact
Susan McCarron
617.986.5767
susan_mccarron@lpp.com

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PALO ALTO, CALIF. – August 1, 2012 – In recognition of his innovation and success in transforming the clinical trial landscape by offering cutting-edge analytics, PharmaVOICE magazine has named Comprehend Systems, Inc. CEO Rick Morrison to its annual list of the 100 most inspiring people in the life sciences industry (full article). Empowered by much-needed change in clinical development, Rick is a leading member of the entrepreneurial team that created the first clinical visualization and analytics software tailored specifically for modern clinical data systems.

After 10 years writing and architecting clinical analytics software, including tools used by the FDA and top pharmaceutical companies, Rick saw that the problems facing the life sciences industry, such as patient safety issues and the rapidly rising cost of tracking increasing volumes of data, were not being solved by traditional approaches. Motivated by these challenges, he and Jud Gardner co-founded Comprehend Systems in 2010 to offer researchers the ability to access, understand and explore data in real time – with the ultimate goal of improving day-to-day life across the world by helping to bring new drugs to market quicker and more safely.

“My partnership with Rick has been successful in part because he brings both technology expertise and a passion for moving the industry forward to our company,” said Jud Gardner, co-founder and chief technology officer of Comprehend Systems. “Our leadership team at Comprehend Systems has been positively impacted by Rick’s dedication and passion for developing clinical technology that improves the speed, efficiency and safety of clinical trials. I am confident that we will continue to create and provide the tools that fill a critical industry need.”

Since Rick and Jud founded the company, Comprehend Systems secured $1.2 million in seed funding in 2011, and sponsors and CROs have quickly recognized the company’s ability to enable a new level of access to clinical data to overcome key development roadblocks. Comprehend Systems most recently drove the launch of a cloud delivery model for its flagship product Comprehend Clinical, which empowers all of the stakeholders in a clinical trial to seamlessly answer all questions in real time, regardless of where the data resides.

Established eight years ago by PharmaVOICE magazine, the PharmaVOICE 100 is an annual list of individuals recognized for their positive contributions to the life sciences industry. Nominated by thousands of PharmaVOICE readers, the PharmaVOICE 100 are selected based on well-crafted and comprehensive essays describing how individuals inspired or motivated their colleagues or peers or affected positive changes in their organizations, as well as other factors, such as community and philanthropic activities. The PharmaVOICE 100 represent a broad cross section of industry sectors, including pharmaceutical, biopharmaceutical, biotechnology, contract research, clinical trial, research and development, patient education, patient recruitment, advertising, technology and many others.

“Since founding Comprehend Systems in 2010, CEO Rick Morrison has led the company to its first round of funding — $1.2 million – and the launch of its first product, Comprehend Clinical,” said Taren Grom, editor, PharmaVOICE. “Mr. Morrison, who is a strong leader, has a clear vision of the sponsors’ need for robust visual data reporting and analytics tools in support of clinical trials. For these as well as many other reasons, he is being honored as a 2012 PharmaVOICE 100.”

Tweet this: Comprehend Systems CEO @morrisor named to @PharmaVOICE 100 #PV100 @comprehend http://bit.ly/NI40S3

About PharmaVOICE:

PharmaVOICE is expressly written and designed to deliver the views, opinions, and insights of executives who are shaping the direction of the dynamic life sciences industry. PharmaVOICE reaches more than 29,000 subscribers every month in print and more than 100,000 readers through its online version, which contains original exclusive bonus content. PharmaVOICE’s unique horizontal editorial approach cuts industry silos, providing a holistic overview of the life sciences industry, addressing a range of topics from molecule through market. By engaging compelling personalities from diverse industry sectors, PharmaVOICE provides multiple perspectives on business challenges, trends, and topics. Editorial content sparks dialog, initiates debate, and opens the lines of communication to facilitate and improve business-to-business relationships. PharmaVOICE’s multiple-perspective and in-depth original forums, feature articles, topics, and departments are audience-driven. PharmaVOICE provides executives with useful peer-to-peer insights on a broad range of life sciences business practices and topics.

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers clinical data visualization, analytics and reporting software that improves the way clinical researchers access, understand, explore and analyze data. Designed specifically for clinical researchers, Comprehend Clinical ™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

Contact

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Unfortunately we were extremely busy and didn’t take as many pictures as we would have liked, or even a group shot, but here are a couple:

Also, here is the presentation we used on our screen:

If you’d like to learn more and missed us at DIA, watch our introduction video or request a demo.

PALO ALTO, CALIF. – June 20, 2012 – As more and more research sponsors leverage hosted services for clinical data collection and management, Comprehend Systems has made it even easier for drug developers to quickly access comprehensive data analytics, visualizations and reports with Comprehend Clinical delivered from the cloud. With this new delivery option, clinical research teams can make Comprehend Clinical seamlessly available to end users, enabling data analysis across multiple studies, contract research organizations (CROs) or clinical data collection systems, without any changes to internal IT infrastructure or data center.

“While sponsors today have access to some of the best clinical research systems available – like Medidata Rave and Oracle Clinical – most are still frustrated by the lack of powerful, easy-to-use analytics and insight into their data, and might not have the time or resources to undertake another infrastructure deployment,” said Rick Morrison, CEO of Comprehend Systems. “By also offering Comprehend Clinical as a cloud-based solution, we’re giving research organizations the option to become empowered by the analytics they need through their existing clinical systems with little to no IT intervention.”

Comprehend Systems has created ready-to-use cloud-based version of Comprehend Clinical that enables study teams to easily visualize and analyze clinical data from any system, including Medidata Rave, Oracle Clinical, CDISC SDTM or any other commercial or proprietary data source. Other key highlights of the cloud-based delivery include:

• Speed – Researchers can begin accessing clinical data, running reports and exposing potential trial delays or challenges in as quickly as one day.
• Security – Hosted in secure SSAE 16 Type II-compliant datacenters, fully Title 21 CFR Part 11 compliant, validated through BioPharm Systems.
• Scalability and flexibility – Study managers can deploy Comprehend Clinical on a limited number of trials and then expand or reduce the use based on needs, ensuring that there are no wasted resources.

“Many sponsors today not only struggle to analyze their clinical data in a meaningful way, but are also just starting to realize the benefits of storing and accessing data in the cloud,” said Alex Sefanov, founder of BioPharm Systems. “With this fully-validated cloud based option, Comprehend Clinical has proven its ability to deliver a simple, fast and secure way to get comprehensive analytics without impacting sponsors’ IT infrastructure or data centers.

The benefits of the cloud-based delivery model include all the features of Comprehend Clinical, which can also be hosted on-premise, including:

• Dashboard embedding –Dashboards can be embedded on any external website, web portal or SharePoint and also work on any mobile device.
• Broad chart selection – Researchers have access to Pareto charts, candlestick plots, regression lines, pie charts and dashboard meters – that all enable full drill-downs into any other chart on the system and intelligently handle missing data.
• Click through and drill-down – Users can click-through from any visualization or dashboard into any other view on the system.
• Cross-study, cross-CRO, cross-datasource – Comprehend Clinical works across all clinical data, regardless of where it resides.
• Drag-and-drop ad-hoc reporting – Users can easily and quickly create more complex visualizations and customized, real-time reports.
• Real-time alerting – Every user can set up alerts on any aspect of the trial to be notified when the data changes through SMS or email.

Comprehend Systems will be demonstrating cloud-based Comprehend Clinical at the DIA Annual Meeting in Philadelphia, June 24-28, at booth #2516.

Tweet this: .@Comprehend Systems announces #analytics for #clinicaltrials delivered from the #cloud

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers clinical data visualization, analytics and reporting software that improves the way clinical researchers access, understand, explore and analyze data. Designed specifically for clinical researchers, Comprehend Clinical ™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

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PALO ALTO, CALIF. AND CAMBRIDGE, MASS. – May 3, 2012 – While clinical development technologies have come a long way in recent years, research sponsors continue to struggle to connect disparate systems and attain easy access to critical data that will enable better reporting, faster problem solving and increased operational efficiencies. In response, Quanticate, the leading data-focused global clinical research organization (CRO), chose Comprehend Clinical™ to integrate into its future research tools as a key part of its strategy to expand its offerings to meet growing sponsor demand for real-time communications and comprehensive clinical data analytics.

Tweet This: #CRO @Quanticate selects @Comprehend for analytics and visualization for #clinicaltrials

“We are excited to be able to provide our sponsor customers a more user-friendly, cost effective approach that overcomes the limitations of analytics and visualization tools that are costly and cumbersome to implement and integrate with other systems. Our approach will help our customers get to the data they need to answer critical questions,” said Daniel Chapple, chief commercial officer at Quanticate. “Our selection of Comprehend Systems is a fundamental step in our vision to provide our customers with centralized clinical data services that helps them resolve this data access challenge.”

After Quanticate conducted a thorough evaluation of a range of data analytics vendors, Comprehend Clinical was chosen for its easy-to-use web-based platform and ability to seamlessly integrate into existing clinical systems. The Quanticate team also valued how the system allows researchers to easily find answers to their problems and dig into key data with no additional programming or complicated spreadsheets.

“During our evaluation process of visualization and analytics software, it became clear that Comprehend Clinical’s competitive advantage is its ability to pull data from any source and deliver it in a way that makes sense to researchers,” said Michael Whitworth, vice president of centralized clinical data sciences at Quanticate. “Comprehend Clinical will enable our sponsors to not only drill down and solve unique, specific problems in real time, but also provide a higher level view of data to tackle broader operational challenges.”

“As a leading CRO, Quanticate clearly understands the regulatory, clinical and financial pressures sponsors are under and is aggressively implementing the technologies and services that solve the industry’s biggest pain points,” said Rick Morrison, CEO and founder of Comprehend Systems. “Given our shared commitment to improving the way clinical research is conducted, Quanticate’s strategy to integrate our solution makes perfect sense, and we look forward to successes with joint customers in the months ahead.”

About Quanticate

Quanticate (www.quanticate.com), with headquarters in the UK and USA, is a specialist clinical research organization (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. With a global footprint, Quanticate provides efficient outsourcing solutions for companies who need additional capacity or who want to outsource certain functions in their entirety. Clinical trial management services include scalable on-site and off-site data management, statistical consultancy, statistical programming & analysis, medical writing and pharmacovigilance.

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers clinical data visualization, analytics and reporting software that improves the way clinical researchers access, understand, explore and analyze data. Designed specifically for clinical researchers, Comprehend Clinical ™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

PALO ALTO, CALIF. – April 17, 2011 – Designed to help clinical researchers overcome the ongoing challenge of accessing clean, real-time data and reports, Comprehend Clinical 1.1 from Comprehend Systems includes a range of new features that enable sponsors to meet increasing regulatory requirements and leverage industry standards to easily share data across all systems in the clinical trials process.

“From sponsors and CROs to EDC and CTMS companies, everyone is looking for ways to understand how to reduce costs and increase efficiencies, but are still hitting expensive and time-consuming roadblocks when it come to accessing and sharing the data they need to make critical decisions,” said Rick Morrison, CEO of Comprehend Systems. “With this latest release, Comprehend Clinical continues to ease sponsors’ biggest pain points in accessing data, resolving queries, reporting to the FDA and ultimately improving clinical operations.”

Tweet this:  .@Comprehend expands #clinical data visualization and #analytics tool for sponsors, #CROs, #CTMS and #EDC vendors http://bit.ly/II63Cf

Now offering a fully validated solution, Comprehend Systems worked with BioPharm Systems to secure Title 21 CRF Part 11 compliance for Comprehend Clinical 1.1 and also put new standard operating procedures (SOPs) in place. In addition, the system’s new CDISC Study Data Tabulation Model (SDTM) adapter allows sponsors to connect Comprehend Clinical 1.1 to any SDTM data source and easily configure new SDTM studies.

“Comprehend Clinical 1.1 meets critical regulatory requirements that enable sponsors to submit fully validated electronic reports to the FDA, further streamlining the new drug submission and approval process,” said Alex Sefanov, CEO, BioPharm Systems. “With this new release, Comprehend further extended its commitment to the exchange of data using industry standards and meets a growing industry need for a solutions that enables sponsors to easily access and analyze data anytime and anywhere.”

Comprehend Clinical 1.1 also further improved its ability to connect researchers with key data with the following new features:

• Dashboard Embedding – Comprehend Clinical’s dashboards can now be embedded on any external website, web portal, SharePoint site and more. Based only in HTML and JavaScript, Comprehend dashboards also work on any mobile device, including the iPad and iPhone. Comprehend dashboards make it easy for users at any level of an organization, including data managers, CRAs, study managers and clinical operations executives to identify and adjust based on data trends. When a Comprehend dashboard raises a question that isn’t immediately answered within the dashboard, users can drill down (or “click through”) into any other pre-existing report or visualization.
• Expanded Chart Selection – Comprehend Clinical 1.1 now includes a range of new charts – including Pareto charts, candlestick plots, regression lines, pie charts and dashboard meters – that all enable full drill-downs into any other chart on the system and intelligently handle missing data. When certain points aren’t displayed on a graph because of missing or null data, Comprehend Clinical 1.1. is able to intelligently describe what was hidden, and allow the user to explore it further.

Comprehend Systems will be demonstrating its latest version of Comprehend Clinical at The DIA Annual Meeting in Philadelphia, June 24-28, at booth #2516.

About Comprehend Systems, Inc.

Comprehend Systems, Inc. (www.comprehend.com) offers clinical data visualization, analytics and reporting software that improves the way clinical researchers access, understand, explore and analyze data. Designed specifically for clinical researchers, Comprehend Clinical ™ enables data managers, monitors and clinical operations executives to identify broad operational and clinical trends across trials and also easily drill down and report on a wide range of factors, including safety issues, regulatory requirements and opportunities for critical time and cost savings. Comprehend Systems was founded in 2010 in Palo Alto by a team of entrepreneurs with decades of combined experience in clinical research and software development.

Contact

Susan McCarron
617.986.5767
susan@comprehend.com

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