Portals and Document Management

Technology has evolved over the years in a response to issues encountered in the workplace.

In this column, Dr. Kirk Mousley and and guest author, Michael J. Hoy discuss portals as the authors believe that it is a very relevant technology that attempts to provide solutions to several common business problems.

It has been over five years ago, that Kirk presented "Clinical Research Collaboration Using Portals" at a Philadelphia Chapter of the ACRP Smooth Sailing Conference and while the technical landscape has changed, the business issues addressed by portals remain the same.

For more details on what has changed and how that might affect you - Please click on the icon below to see the complete article (PDF).

Revisiting the "Do It" Button

"For some reason I was reminiscing this past weekend on one of my past consulting assignments at a local biotechnology company. I recalled a discussion I had with a woman who was the director of Data Management there at the time. We were talking about the frustrations we had with program specifications, and she laughed, and said, 'What I want is a big red button in the middle of the screen that says "Do It," and all I have to do is click on the button and everything is done properly!'"

Is this purely wishful thinking or can modern technology achieve this level of automation even in a fast changing, regulated Pharmaceutic world?

For more details on what you can do to get a "Do It" Button - Please click on the icon below to see the complete article (PDF).

ACRP 2011 Global Conference Presentation

Dr. Kirk Mousley continues to present new ideas and his insights at the ACRP annual meetings.

Join him in Seattle, Washington April 30 – May 3, 2011 for the ACRP 2011 Global Conference & Exhibition where he will be giving a presentation titled "Creative and Critical Thinking in a Regulated Environment".

Session Date: 5/1/2011 09:15 - 10:15 AM.

Creative thinking and critical thinking work in concert to spur innovation. Creative thinking produces new ideas; critical thinking evaluates these ideas and determines their worthiness and how to implement them. Both are needed to improve current processes and tools.

The pharmaceutical industry is a heavily regulated industry, in which employees must follow SOPs, and be aware of and compliant with FDA regulations. Sometimes these regulations stifle creative and critical thinking.

Many businesses, not only in the pharmaceutical industry, need employees to follow set procedures, especially in a manufacturing environment, to ensure quality and consistency of the end product. As a result, creative and critical thinking not only aren't encouraged, but often are discouraged among "production" employees.

The use of standards in the pharmaceutical industry, especially in the clinical data management area, can sometimes conflict with creative thinking; yet, critical thinking is crucial in this area. A thorough evaluation of proposed changes must be made in conjunction with an understanding of the value of standards.

The FDA is not always clear or timely in producing regulations and guidelines, and it is this lack of clarity and timeliness that often stifles, or even paralyzes many companies' efforts to improve processes and implement new technology.

In this presentation Dr. Kirk Mousley will discuss both creative and critical thinking as it applies to in the pharmaceutical industry and offer insight on how to encourage it - for the better.