Saving Time by Meeting CDISC Standards



Pharma IQ
07/30/2010

In most spheres of business, the success of companies strongly depends on the data they possess. However, the management of such information is almost as important as the actual detail itself, as it can impact on a firm's operations and how they meet guidelines set out by regulators.

Such trends are common in the pharmaceutical industry, where data is generated across a range of stages from pre-clinical to post-marketing phases. Central to information management in the industry, is the non-profit organisation CDISC – also known as the Clinical Data Interchange Standards Consortium.

The body's aim is to establish standards that support the acquisition, exchange, submission and archiving of clinical research data. In fact, as the area continues to evolve, standards in the area are also changing, so much so that the CDISC recently outlined where it stands in 2010.

At the end of January, the organisation confirmed that its key focus area for this year is to see its standards adopted at the "front end" of medical research. This will mean that guidelines are followed from the moment a study on a drug or product is developed or designed, as this could offer companies a range of advantages.

"Why? Well it's simple, by using standards from the start, you can gain the greatest benefits in terms of the time and cost savings and reap the highest quality data, an extremely valuable asset," the CDISC explained in its statement.

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CDISC added that the key drivers influencing its goals in 2010, include rising support for new and existing standards, the continuation of collaborative development and management on a global basis, as well as the identification of new funding opportunities.

It is also working with the US Food and Drug Administration (FDA) over its need for new standards in relation to efficacy and the refinement of the Study Data Tabulation Model, which is currently submitted as part of product applications made to the authority. CDISC is currently working with FDA representatives and will update its overall 2010 goals in the future to reflect the discussions.

Other areas that the body is looking at include its collaborations, and it is in the process of developing a website that will highlight to its members where their voices are now being heard. In addition, CDISC has been considering how to develop its communications strategies, most notably its use of digital platforms.

"We launched a Twitter account, in order to microblog our activities and we recommend you follow this if you are not already doing so," the organisation outlined.

"Perhaps our major achievement last year was the launch of the new CDISC website, which has proved to be a popular move, judging by the number of hits we are getting and the great feedback we have received."

Since outlining its plans for 2010, CDISC has been involved in a range of activities. One of the most recent saw it name Nextrials as one of its 15 registered solutions providers, as well as the sole firm offering an electronic data capture (EDC) product supported the CDISC Healthcare Link Initiative.   

Rebecca Kush, CDISC president and chief executive officer, said the use of EDC systems in the healthcare industry can be highly beneficial, so the firm should be applauded.

She explained: "By using a standards-based process, workflow for clinical research can be integrated into the workflow for clinical care. This streamlines the process for sharing clinical care information for multiple uses including research and public health." This in turn means that the time taken over data entry is reduced, she added.

While Nextrials will be saving many firms time by meeting the CDISC standards, it is unlikely that the latter will have much of a breather. The body began the year with a flurry of activity and the pace is unlikely to let up, as the clinical data management needs of the pharmaceutical industry evolve.

As the CDISC itself stated: "We are grateful to those companies who have shown us continuous support and those individuals who give up valuable time and effort to ensure that we have an efficient and truly collaborative development process."

"2010 will be as busy as ever and we look forward to you joining us on the journey."