21 October 2017
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EHR4CR – preparing for deployment

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EHR4CR is one of the largest public-private partnerships aimed at providing adaptable, reusable and scalable solutions for re-using patient level data from Electronic Health Record systems for Clinical Research. The presentation will focus on recent achievements and near term plans as the project prepares for deployment during 2015:
1. Results of the pilots in protocol feasibility
2. Business modeling activities and the estimated benefits of EHR4CR from different stakeholder perspectives
3. Details of the EHR4CR network that will be deployed and the program for early adopters
4. Governance and the role of The European Institute for Innovation Through Health Data


File size 2755 K
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Date Wed 03/18/2015 @ 04:18
Author Richard Perkins
EMail richard.perkins@con7.com

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Bridging the gap on eSource Conformance

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Healthcare electronic data acquisition and interoperability are attracting as much attention through impressive but costly pilots and technological advancements in the past 10-15 years as they do through the intricate competing technology standards and often variable regulatory interpretations of the EHR-Systems governance and quality. In an aftermath of the CDISC eSource Data Interchange Document, the eClinical Forum has been working since 2006 in aggregating functional and quality criteria applicable to electronic Source systems using the predicate Regulatory and International Standards references. after reflectively reviewing them, the forum successfully compiled and disseminated them in form of functional profiles, generic user requirements and practical considerations to its historical members (pharmaceutical sponsor or CRO companies), but also major healthcare system (EHR-S) vendors, academia, the regulatory agencies and standards development organizations

File size 2270 K
Downloads 1
Date Wed 03/18/2015 @ 04:10
Author Richard Perkins
EMail richard.perkins@con7.com

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EHR4CR – An Innovative Platform and Business Model for Re-Use of EHR for Clinical Research

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Improved access to patient data is key to managing bottlenecks in clinical research. The presentation will give an overview of one of the largest public-private partnerships aimed at providing adaptable, reusable and scalable solutions for re-using patient level data from Electronic Health Record systems for Clinical Research. The presentation will give an insight into how the EHR4CR platform and services will:
1. Enable re-use of electronic health records to do better upfront protocol optimization and planning.
Today… A third of protocol amendments are avoidable; over 40% of amendments occur before first patient first dose
2. Provide tools for sites to identify candidates for clinical trials by electronically searching EHRs in order to improve patient recruitment which is one of the biggest challenges for clinical research. 
Today… 50% per cent of clinical trials fail to achieve the target recruitment rate
3. Connect healthcare and research systems to improve the capture and exchange of clinical trial data. 
Today… Over 40% of clinical trial data is entered manually into both healthcare and research systems; Transcription errors increase the workload for monitoring, querying, and responding to queries; Complex processes must be put in place to manage the ‘source’
The project will complete in 2015. During 2014 the project will be engaged in activities for externalisation of the platform and services.


File size 1527 K
Downloads 2
Date Mon 03/10/2014 @ 03:57
Author Richard Perkins
EMail richard.perkins@con7.com

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eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data for Clinical Trials

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It is important that electronic health record systems (EHRS) that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors ultimately bear the responsibility for ensuring that data sourced from these systems are acceptable. As a result investigators are frequently being asked to complete sponsor-specific assessments of their EHR systems.  
Now there is a free tool available that can help sites to do this quickly, easily, and once for all sponsors. 
The eClinical Forum, a non-commercial, global organization  whose  membership consists  of biopharma, CROs, technology providers and academia has developed a self-assessment tool that sites, with the aid of their EHR vendors, can use to provide this information to sponsors, CROs, and regulators. The site can quickly identify if its system and/or processes are compliant with research regulations or if additional processes need to be put into place.
Using this assessment tool will enable sponsors to evaluate and manage risk. Regulators and sponsors should feel confident in the quality of eSource coming from assessed sites.
The presentation provides an overview of the assessment tool, and information on accessing and using the tool.


File size 403 K
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Date Mon 03/10/2014 @ 03:54
Author Richard Perkins
EMail richard.perkins@con7.com

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EHR4CR – An Innovative Platform and Business Model

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EHR4CR – An Innovative Platform and Business Model
• The rationale for re-use of Electronic Health Recrods
• EHR4CR Project overview and status
• Business case
• Business model for service provision and governance
Richard Perkins, eClinical Forum, President

EHR4CR Platform for Protocol Feasibility and Patient Identification
• Usage scenario, design and infrastructure of the platform
• Demonstration of functionality
Töresin Karakoyun, Coordination Center For Clinical Trials, Head of Clinical Research Informatics


File size 2391 K
Downloads 1
Date Thu 02/20/2014 @ 03:50
Author Richard Perkins
EMail richard.perkins@con7.com

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