Society for Clinical Trials Annual Meeting
May 19-22, 2013, Boston, MA
Presentation: “Pulling the Trigger on Risk-based Monitoring”
Date & Time: Monday, May 20, 12:45 p.m. ET

In the contributed paper presentation “Pulling the Trigger on Risk-based Monitoring,” Morrison will discuss how sponsors can transition to risk-based monitoring practices using advanced data insights tools. He will demonstrate how to put the underlying tools and strategies in place so that clinical trial sponsors can automate and streamline complex criteria and processes to enhance the efficiency of the entire site monitoring process – leading to significant cost reduction of each trial.

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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
Katie Huber
617.986.5729
Katie_huber@lpp.com

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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In 2013, risk-based monitoring should be a critical component of every clinical trial sponsor’s strategy to alleviate financial strains and eliminate inefficiencies across trial processes. Site monitoring is an essential element of clinical trials, yet 100% source data verification (SDV) of research data is an extremely time-consuming and expensive process and, in addition, is often ineffective because the sheer volume of data can overwhelm reviewers. Not surprising- ly, the FDA now is recommending sponsors shift toward implementing more targeted, risk-based monitoring practices.

Risk-based monitoring can reduce over- all costs by more than 20% in a large, phase III trial, and reduced SDV could save the industry billions of dollars per year. It also plays a key role in improving patient safe- ty, as monitors review smaller amounts of more focused data with greater accuracy. Today, EDCs and CTMS systems are col- lecting data centrally, making it available for analysis in real time. Modern analyt- ics tools and technologies will continue to drive the emergence of centralized moni- toring, because they provide new and pow- erful insights into data in time to still make it actionable, ultimately affecting a better study outcome.

Best practices already have begun to emerge, although it’s still in its infancy. The pioneers of risk-based monitoring have been using very labor-intensive processes to determine when and where trigger events occur. New technologies are becoming available to implement risk-based monitoring in an automated way. These technolo- gies quickly and efficiently alert monitors to potential issues without burdening them with highly repetitive, error-prone tasks. With the right tools in place, sponsors have the ability to reduce site visits, dramatically cut costs, increase effectiveness and im- prove safety, facilitated by better technol- ogy to assist and automate where possible.

As regulatory and financial pressures continue to increase, it will be critical for sponsors to determine how to begin imple- menting risk-based approaches to cut costs and enable more effective monitoring.

As a new calendar year begins, the fi- nancial and regulatory pressures on sponsors will continue to increase. Those companies that can create or evolve into scalable and agile businesses will suc- ceed, while those that can’t will disappear. To ensure survival, pharmas must focus on a few key actions in 2013:

Adopt a modern outlook: With con- stantly evolving technologies and processes, what has worked in the past will be obsolete and inefficient. Sponsors must modernize processes and integrate new technologies into their pipelines to increase efficiency and provide clarity across the spectrum. Oth- erwise, they will find themselves at a major disadvantage as they become outdated and incompatible with CROs and other partners.

Give trials a dynamic flavor: New pro- cesses that enable better, quicker reactions throughout a trial will take off in 2013, but sponsors need to understand how to fully integrate these tactics and take advantage of all opportunities to make changes along the way. Strategies such as risk-based moni- toring, adaptive clinical trials, centralized analysis and targeted treatment for patients will be key to enabling this flexibility.

Take a risk in R&D: Sponsors have been hesitant to pursue blockbuster drugs and instead have been targeting orphan drugs, concerned about the unknowns of block- busters—primarily that with millions of pa- tients, some subset are likely to experience negative side effects, leading to lawsuits. Sponsors must embrace modern technology and techniques and target common condi- tions. With boldness will come huge returns.

Consolidate R&D technologies: Having too many e-clinical systems results in regu- lar bottlenecks, roadblocks and expenses, while incompatible systems decrease ef- ficiency and waste valuable time. Pharmas must consolidate systems and rely on tech- nologies that break down silos rather than create new ones.
The new year brings exciting possibili- ties for innovation and success. The strong will survive by taking actionable steps to improve efficiency and modernize trial pro- cesses for a collaborative approach to the future.

Next: A look at risk-based monitoring.

For clinical trial sponsors, 100 per cent source data verification (SDV) of research data is an extremely time consuming and expensive process, involving thousands of hours of manpower for a single trial. Beyond just being expensive, 100 percent SDV is often ineffective, because there is so much data that the reviewers are overwhelmed and can’t see the forest for the trees. It’s no wonder that the FDA is now recommending that sponsors shift toward implementing more targeted, risk based monitoring practices. Reducing site visits has the potential to dramatically cut costs, increase effectiveness and improve safety by better allocating available resources to where they’re needed most.

Download the full whitepaper here

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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