Aptia Systems Presents at FDA's "Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practices"
Aptia Systems Founder presents thoughts and observations on Informed Consent
HOUSTON, May 1, 2012 /PRNewswire/ -- On Monday, April 23rd, Aptia Systems, Inc. presented at the FDA's hearing titled "Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practices". Mr. Royce Heslep, President and CEO of Aptia Systems, Inc., spoke on using technology to improve gathering and managing the informed consent process. Mr. Heslep spoke on the benefits of various technologies to improve communications with research subjects, reduce waste in the data collection process, and improve collaboration among all parties involved.
"The common practice of using a paper-based system is very cumbersome, time consuming and prone to making mistakes," said Heslep. "The good news is some organizations are beginning to adopt modern data-storage technologies discussed and we expect this trend will continue and accelerate over the next few years."
Thousands of volunteers participate in clinical trials each year. To participate in a clinical trial each volunteer has the right to know and understand what their involvement in a clinical trial will entail. The communication between the researcher and subject is the informed consent process. Some of the information that must be disclosed is the purpose of the research, potential benefits and risks, alternative courses of treatment, time involved and that the trial is voluntary.
A desire to improve the informed consent process was expressed by many presenters. Some ideas proposed were to shorten and simplify forms, provide better training and possible certification for personnel collecting the informed consent, and standardization of forms at federal and state levels.
About Aptia Systems
Houston-based Aptia Systems is a custom software development company helping businesses and medical research centers maintain their competitive edge. Servicing a wide range of industries, Aptia Systems has created over 300 user-friendly software applications and products that streamline complex administrative processes and improve organizational performance. In addition to the Silverlight partner ecosystem, Aptia Systems is also a Microsoft Certified Partner and Front Runner Partner for Windows Server 2008 R2.
Aptia is a trademark or registered trademark of Aptia Systems, Inc. or its subsidiaries in the United States and other jurisdictions. All other company and product names may be trademarks or registered trademarks of their respective companies.
Gary McNeel, Jr., Business Development for Aptia, 713-458-1070, email@example.com
SOURCE Aptia Systems, Inc.
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