Does technology integration improve clinical trial perfor­mance? As technology enable­ment continues to expand, so do expectations surrounding trial performance.

While there is much emphasis on research technology enable­ment to improve efficiencies, few address automation of business processes, integration of systems and services and the secure shar­ing of data across numerous appli­cations. Even fewer measure the impact on trial performance.

Imagine having the ability to identify patients, connect regula­tory documents, pull clinical data, perform analysis and produce measureable results in less time and with fewer queries. Leverag­ing technology innovation in silos and in the absence of integration will not improve trial perfor­mance. Many technologies are a result of a single platform, which address a single issue (HRPP, CTMS, EHR, etc.), and are not integrated to connect systems in­ternally and externally. Develop­ing integrated solutions remain a challenge for sponsors and sites.

The key is “true” data integra­tion beyond data flow or trans­fer. Integration enables real-time compliant performance through­out the trial and allows for im­proved workflow management. Researchers need to be able to screen patients based on inclu­sion/exclusion criteria from the EMR, consent/enroll with e-con­sent capability, capture all data elements from the EMR in the eCRF or CTMS, run statistical modeling in SAS/SPSS and im­pact patient adherence without duplication or error—and in less time. An integrated technology platform improves overall trial ef­ficiency, reduces costs and enables quality and accuracy.

With the introduction of system integration across the research enterprise, trial performance can move forward, stay agile and con­tinue to innovate.

Written by Guest Writer Erika Stevens. Stevens is a Senior Managing Director at FTI Consulting, leading the Research Technology practice as part of the Research and Compliance practice. Within her 20 years’ experience in leading clinical research operations, administration and compliance activities at various institutions, she often works with clients to grow the research enterprise, improve system/process integration and streamline organizational research operations. www.fticonsulting.com

This article was reprinted from Volume 23, Issue 05, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>