October 2013

For Pharmaceutical Companies

FDA Strategy for Clinical Drug Development

by Robert L. Kunka, The Kunka Group, Inc.

The idea of interacting with the FDA is sometimes mysterious and unsettling for a pharmaceutical company. The average person finds it difficult to work with a large organization that they don’t understand. Bob Kunkel, who has guided many companies through this territory, outlines what to expect from the FDA while guiding a clinical drug through the approval process.

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Three Common Issues Involving Clinical Trials

by Cindy Fazzi, MasterControl Inc.

In clinical research, there are two major regulatory concerns: patient safety and data integrity. While there are many possible reasons for regulators to conduct an inspection during a clinical trial, most of the time, it’s to verify these two things and to ensure that the research is being conducted according to the study protocol and GCP regulations.

If your company is sponsoring a clinical trial or if it’s a CRO conducting research on behalf of a sponsor, are you ready for an inspection?

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MasterControl Receives Software Magazine Award

by Software Magazine

Software Magazine recently ranked MasterControl Inc. as one of the world’s Largest software companies. This is the fifth year the company achieved this recognition.

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Coming Soon:

In the next issue of GxP Lifeline…

MasterControl’s Cloud expert Victor Gill is back with a second installment on “MasterControl.Cloud.” In his first article, he explained in layman’s terms what the Cloud is. In the next issue, he’ll talk about how working in the Cloud can make you more efficient in your work.

Vivian Bringslimark discusses online training. She poses the question: SOP training is now online but are we any more compliant because of that?

The selection of a new supplier can be an arduous process, and the importance of the decision is inarguable. Jennifer Stepniowski explains grid analysis, a useful and easy tool to use when choosing a supplier.

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