New Publication: eSource Records in Clinical Research: Keeping it Simple

 

On April 16, 2015, Applied Clinical Trials published an article, entitled: “eSource Records in Clinical Research: Keeping it Simple.“ What is very special about this paper are the esteemed co-authors, 4 of whom are industry experts in their own right:Jonathan Helfgott, formerly Associate Director for Risk Science, Intelligence, & Prioritization FDA and now Director of Regulatory Affairs at Stage 2 Innovations; Tom Haag, Data Integrity Process Expert; eClinical Quality Assurance at Novartis Pharmaceuticals Corporation; Silvana Cappi, Executive Director, Biometrics, at Ferring Pharmaceuticals and Imogene McCanless, Senior Vice President, Biometrics and Regulatory Affairs, at TransTech Pharma, LLC, and 4 from Target Health (Jules Mitchel, Joonhyuk Choi, Yong Joong Kim, Timothy Cho, and Dean Gittleman).

 

Excerpt: “In this paper, we have demonstrated ways to satisfy regulatory concerns about data integrity and investigator controls over their source records, when incorporating 21st Century tools and processes as standard elements of clinical development operations. These solutions include 1) data entered directly into EDC systems at the time of the clinic visit, as well as 2) seamless integration with the EDC study database with data residing in the EMR, and ePRO systems. Integrating eSource solutions with the EDC database will result in the ability 1) to review data in real time, 2) for monitors and clinical sites to rapidly issue and respond to data queries, and thus improve quality, and 3) to reduce time and materials spending associated with data acquisition and review.“

 

Triboro Bridge in the Fog

 

We were on our way to Boston and here is what the Big Apple looks like from the train on a foggy afternoon.

 

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Triboro Bridge in the Fog – ©Target Health Inc. 2015

 

ON TARGET is the newsletter of Target Health Inc., a NYC-based, full-service, contract research organization (eCRO), providing strategic planning, regulatory affairs, clinical research, data management, biostatistics, medical writing and software services to the pharmaceutical and device industries, including the paperless clinical trial.

 

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.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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