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Compliance In Focus
Posted by John Lehmann on Tue, May 14, 2013

Should We Consider Using an Integrated EDC/EHR System in Clinical Research?

Should We Consider Using an Integrated EDC/EHR System in Clinical Research?Being a CRO that specializes in helping companies gain FDA and world-wide approval through monitoring, auditing, training and consulting services- it’s fair to say we’ve come across a wide range of fellow CROs, investigative sites, research teams, and hospital systems. It’s amazing how much innovation exists- not just with the investigative products- but with technological advances to platforms used the healthcare industry.

A recent article, “5 Reasons For Using Integrated EDC/EHR Platforms” explores the up and coming advancement of an integrated platform that could streamline processes within our industry. The article asks a pensive question, “Most researchers today are already using an electronic data collection (EDC) tool to help manage even early-stage clinical trials. Because the collection methodologies for electronic health records (EHRs) are similar, could a single system simultaneously be used for patient care in both the hospital/clinic and clinical trial settings?”

Many believe that using an integrated system will allow for better workflow in clinical research studies, and perhaps new tools in this area will help bring more innovative products to market in a quick, cost-effective method. How will this type of hybrid system prove beneficial? The article points to five reasons to consider using an integrated EDC/EHR product for a clinical research study:

  1. Pre-identification of sites with appropriate patients for even the most tightly focused study
    This, in turn, fosters fewer enrollment delays — an important consideration from not just a cost standpoint but from the implementation requirements of a competitive, go-to-market strategy.
  2. Research costs are considerably lower due to certain economies
    For example, study monitors and research associates do not need to travel to sites as often for source data verification because 80% to 90% of the data is typically taken directly from the EHR.
  3. Greater pool of potential sites, even those that are research naive, because the startup requirements are significantly lowered through an integrated EDC/EHR platform
    The potential patient pool is also increased, as those living far from large medical centers can now enroll through smaller, more localized clinics.
  4. Improve data input accuracy
    By removing the potential for transcription errors, data quality is improved.
  5. Information that isn’t normally collected within a site’s EHR can be collected on eCRFs (electronic case report forms) that are displayed in the EHR interface.
    Using one interface can help with problems in workflow and duplicate data entries.

Do you currently use a hybrid system? What are your thoughts on an integrated platform? Share your pro/con list below.

Photo Credit: Jackie & Dennis

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Topics: Electronic Data Collection, Electronic Health Records, Clinical Research

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