Nextrials Reveals 5 EHR-Specific Predictions for 2016
Electronic Health Records Will Have a Dramatic Impact on Clinical Research Next Year
(firmenpresse) - SAN RAMON, CA -- (Marketwired) -- 12/08/15 -- , a leader in clinical research software and services, today revealed its 2016 predictions related to electronic health records (EHR) for the clinical trials community. With EHR''s widespread adoption over the last few years, the company predicts these systems will now change how life science companies and medical facilities conduct clinical research.
"It''s going to be an eventful and exciting 2016," said Nextrials CEO James Rogers. "The infrastructure is now in place that allows us to rethink how we conduct clinical trials. With the renewed focus on eSource being driven by the FDA and industry standards groups like CDISC, we will see sponsor companies and sites take advantage of EHR systems to streamline clinical research."
Nextrials'' 2016 predictions include:
the FDA''s solicitation of eSource proposals resulted in including submissions by leading CROs and pharmaceutical companies. This official proclamation of support has signaled to the life sciences industry that the FDA encourages, even expects, that this paradigm will be implemented.
to take advantage of the efficiencies offered by EHR systems, sponsors will need to place their studies at sites that have EHR systems and processes that easily allow access to the data for research purposes. The EHR system used at a site will be one of the factors evaluated when selecting sites for a clinical trial.
having a principal investigator who is a key opinion leader in his or her field will always be a big draw for sponsor companies, but having a robust EHR system will allow sites to reliably demonstrate that they have sufficient patients that meet the study criteria. And owning an EHR system capable of auto-populating the study database would also be a valuable asset.
a network of sites offering study-specific patient identification and selection, combined with the validated transfer of trial data directly from the EHR, multiplies the efficiencies seen with individual sites. This would be a compelling business case that enables site networks to flourish where previous attempts at Site Management Organizations (SMOs) have failed in the past.
using EHRs for clinical research has a number of advantages. The most significant for sponsor companies is the potential to reduce monitoring costs by utilizing remote access to patient records for data monitoring. This practice will expand significantly in 2016 as sites adopt the necessary infrastructure and policies, and sponsors begin to wean monitors from expensive site visits.
Nextrials offers today''s most novel products and services for speeding the delivery of life-saving drugs and medical devices to market. Prism®, its award-winning Electronic Data Capture (EDC) solution, has been used at over 2,500 research sites to streamline the initiation and management of clinical trials. Nextrials has achieved the status of Registered Solutions Provider with the Clinical Data Interchange Standards Consortium (CDISC) for a number of standards including the standard for integration with electronic health records (EHR). The company is headquartered in the San Francisco Bay area. For more information, visit or call 925-355-3000.
Reid Wegley
VOXUS, Inc.
253-444-5652
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Datum: 08.12.2015 - 10:12 Uhr
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