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A True Collaboration – EDC & Central Labs

Posted by Chris Helton, March 29, 2010, 2:33 AM

I had a great experience presenting the March R&D Directions webinar on “How Central Lab and Electronic Data Capture Providers Can Collaborate Effectively.”My co-presenter was Jonathan Andrus, VP, Data and Study Operations at BioClinica and I have to say that from the start, the entire process was a great collaboration.

Naturally our presentation centered on the emergence of standards and advances in technology. There has been significant progress in these areas, but we wanted to dive a little deeper to explore the opportunities for tighter integration between central labs and EDC systems.

This is becoming increasingly important for sponsors as CDISC estimates that the annual cost to the industry of laboratory data interchange alone is at least $150 million and that between 30% and 60% of that cost could be saved from the use of a standard. Furthermore, the consortium recognizes that the more significant benefit of a standardized data interchange is in terms of time savings in an industry with running costs estimated at $1 million per day!

We were not surprised by the results from the reader poll taken during the presentation. When asked “Do you plan on implementing and embracing the CDISC Lab standard in your organization in the near future?” – 56% said that they are currently using CDISC format for lab data, 36% said they are planning on implementing CDISC and only 8% said no. I would be that is fairly representative of the industry today.

We outlined EDC and lab considerations in each stage of a trial – study design, study start up, study conduct and study closeout – and how the use of standards can converge to create efficiencies between these players to accurately track trial data.

What I thought was valuable to reiterate from the presentation are the benefits to sponsors and CROs that use lab standards.

1) Standards establish a common framework to collect data, which helps accommodate the different practices of any laboratories

2) They allow some “controlled flexibility” on how some data is represented to support differing preferences within the industry

3) Both platform and lab independent data exchange are supported

4) Standards avoids each party having their own unique/custom standards for lab data requirements and transfer, which clearly decreases development time and any cost savings

5) The more standardized lab data is, the easier it will be to collect, process, combine, analyze and submit the results

As a proof point, we recently enhanced our data management system, LabStar, to support the CDISC standard, and for sponsors requesting the data in a standard format, the team has decreased its development time by up to 60%. That adds up to considerable time and cost savings.

Jonathan also provided an overview and status on electronic health records (EHR) initiatives, as he was involved with determining how health care information can positively impact clinical research.

It is definitely worth listening to the webinar on demand, especially if you are considering or in the process of adopting standards for your next study.

We’d love to do a follow up webinar on practical steps on implementing these standards and creating a true collaboration between EDC vendors and central labs. Let us know if you’d be interested!

Category: Data Management