Target Health Presenting at DIA Annual Meeting (Boston) on eSource
Target Health Inc. is pleased to announce that Dr. Jules T. Mitchel will be presenting a talk as part of the “eSource Symposium,” which will take place at the annual meeting of the Drug Information Association (DIA), which is being held in Boston this year (June 23-27, 2013). This symposium is part of the Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA) track.
The symposium will take place on June 27, between 9:00AM – 10:30AM, and will be chaired by our colleague Patricia Beers Block. Pat spent 32 years with the U.S. Food and Drug Administration and was recently Vice President of Strategic Regulatory Initiatives, at Medidata Solutions.
This symposium will introduce risk-based approaches when electronic data are intended to serve as the source of clinical data. Additionally, we will discuss how monitors and data managers can work together when developing and implementing a risk-based monitoring program. A final topic is the assessment of electronic health record systems that will be the repository of eSource data.
Learning objective are 1) understand the principles of risk-based approaches to successfully using eSource clinical data; 2) identify how to implement a risk-based study monitoring approach to electronic clinical data; 3) describe methods to successfully assess electronic health records systems that will be used for clinical data.
A Common Tool for Investigator Site eSource (EHRS) Readiness Assessment – Patricia Beers Block
eSource and Risk-Based Monitoring: Impact on Sites, Data Management and Regulatory Compliance – Edward Stephen Seguine, CEO, Clinical Ink
Is It Time to Change the Clinical Trial Monitoring Paradigm? Results From a Phase 3 Clinical Trial Using EDC Fully Integrated With the eClinical Trial Record for Real-time Data Entry (eSource), Together with Risk-based Monitoring – Jules T. Mitchel, President, Target Health Inc.
For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at www.targethealth.com