SOURCE: Xtalks

Xtalks Webinars

June 02, 2016 07:00 ET

In Pursuit of the Holy Grail: a New Generation Clinical Data Suite, Upcoming Webinar Hosted by Xtalks

From Patient Identification to Submission, What Would Be a "Game Changer" for Flexibiilty, Accuracy, Speed and Cost Efficiency?

TORONTO, ON --(Marketwired - June 02, 2016) - Xtalks will host a complimentary webinar featuring expert speakers from Cmed, an innovative, full service technology-led CRO, including Graham Belgrave, Chief Operations Officer, and Jon Carter, Product Manager.

The clinical research industry consistently faces significant challenges in the successful completion of clinical trials. From finding appropriate and eligible patients (particularly in complex or rare indications) to ensuring the cleanest of clinical data sets, the industry continues to struggle with extended timelines and confounding endpoints. All of which leads to delays in making critical go/no go decisions and drug approvals.

Even in a relatively simple clinical trial, it is likely that multiple computer systems will be used, each concentrating on a specific function or purpose. This fragmentation means the Sponsor/ CRO team may have to interact with multiple vendors (each with their own team), create and review multiple specifications for each system and the integrations between them. This process is expensive, time-consuming and error-prone. Updates which occur during the trial (for example, in response to a protocol amendment) must be coordinated across systems and suffer from the same problems. Data which applies across systems (such as sites and users) may have to be maintained in multiple places and reconciled.

Attempts to move beyond the days of multiple point solutions have resulted in "eClinical platforms" which offer connections to multiple technologies. However, these platforms are normally the result of acquisition of one vendor by another or partnership between different companies. Often resulting in an integrated system that is reliant on moving data from one component to another. While there is a significant marketing effort to promote the capabilities of these integrated platforms, it is difficult to obtain verifiable data on how successful they are. Anecdotally, reports from Sponsors, CROs and even software vendors themselves, indicate that such integrated systems can be cumbersome to deploy and difficult to maintain, with marginal benefits that have little effect on overall project timelines and cost.

The industry is on the precipice of a new generation of integrated systems that will allow opportunities to incorporate and collect data leading to the "right" decisions. These systems will incorporate intelligence to collect and view data points critical to ensuring accurate patient selection and meeting of end points to the satisfaction of EMA/FDA. Through the immediate review of data entry, application of Risk Based Monitoring (RBM), reduced SDV, and increased SDR, we are able to employ central monitoring methodologies to achieve improved patient centricity. This allows for direct access to patients, site staff and intra-site communications; all leading to better decisions and enhanced business strategy -- 'The Holy Grail?'

The ideal is a fully -- and truly -- integrated system, where the technology goes to the data, and can ensure from a protocol/study design perspective patients are appropriate for the study, the data can be uploaded, reviewed, queried/resolved and decisions made -- all instantaneously.

This webinar will explore some of the challenges faced by Sponsors, present a possible solution to these challenges and demonstrate how a truly flexible, new seamless approach will go a long way to answering the question: 'From patient identification to submission, what would be a "game changer" for flexibility, accuracy, speed and cost efficiency?'

Designed to unify disparate elements, Cmed has developed a modular, new generation Clinical Data Suite that consists of a constellation of components, called Encapsia™. Immediate access to entered data drives data quality, patient safety, increases productivity and demonstrates the ability to utilize this real time clinical data for effective and efficient decision making.

For more information or to register for this free webinar visit: In Pursuit of the Holy Grail: A New Generation Clinical Data Suite

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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