Apps and Clinical Trials?

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In this electronic era it is just assumed that there are apps to assist with and to help improve the implementation and maintenance of clinical trials, to connect patients with a clinical trial, to connect the patient with the physician, to help physicians in finding the right clinical trial for their patient, to plan, forecast, as well as track patient enrollment in a clinical trial. Of course, there are apps that will do most of the aforementioned. As I am sure you are aware, there is an app for your iPhone, iPad, blackberry, and other mobile devices. Check out these articles. http://alturl.com/64z7j and  http://alturl.com\4tt3y. If you have not already done so,  you can  also find information on the U.S. National Library of Medicine website http://www.nlm.gov/mobile/. With regard to clinical trial management platforms such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Microsoft SharePoint just to name a few, they have been around for years and are in need of redesign to address the functional gaps that exist.

As we work through this explosion of electronic information/aides, industry is looking for guidance from the Food and Drug Administration. However, there is not a guideline with regard to the management of clinical trials on mobile devices but hopefully FDA will be forward thinking and put something in place soon. There is a guidance that was proposed last year with regard to consumers and health information, the guidance can be found at http://alturl.com/ynjdf. In my opinion, the FDA should employ an expert who can focus solely on mobile device apps for the Life Science space specifically, the management of clinical trials, perhaps, they have a person(s) but I could not find such an expert on their staff.

The future of Healthcare is an open agenda ready for us to fill in the blanks. See an article in the Wall Street Journal titled A Doctor in your Pocket http://alturl.com/whruy. The Healthcare Industry is certainly taking the lead with regard to utilizing the latest technology; see reports in Technology Review magazine published by MIT. http://alturl.com/6s68p and  http://alturl.com/gdxcc

The Biotech/Pharmaceutical industry is trying to contain the rising cost of drug development; in my opinion, it would be quite impressive if industry could be innovative enough to propose a unique process particularly with regard to early stage clinical drug development that would dare all of industry to be different but of course,  insuring that CDER & CBER mission is not in conflict.

 http://www.kgdavisconsulting.com

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