Oct 24, 2013

Three Common Issues Involving Clinical Trials

by Cindy Fazzi, Marketing Communications Specialist, 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?

Common Clinical Trial Issues
The issues faced by sponsors and CROs during inspection vary from one clinical study to another, but here are three types of violations that have warranted FDA warning letters.

Oct 8, 2013

Developing a Winning FDA Strategy for Clinical Drug Development


by Robert L. Kunka, Ph.D., 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.  For example, large banks understand this and advertise themselves as the friendly bank that works to help “their neighbors” with buying a house.  The FDA’s clients are pharmaceutical companies.  Unlike banks, the FDA has significant leverage over the company because it is responsible for reviewing a company’s drug with the hope that FDA will approve it.  While many companies are also large, there is no real leverage that the company has over the FDA.  Thus, the company is at a distinct unsettling disadvantage.  However, both parties have the common desire to market safe and effective drug products.  Where the rubber hits the road is that the two parties need to agree on what is needed to demonstrate that the drug is safe and effective.

Innovation and the Quality Process


by Ken Peterson, Director of Quality and Consultation Services, MasterControl Inc.

Thinking of new ideas and putting those ideas to practical economic use can be more of an art than a science.  At times innovation sends a signal that is in opposition to quality.  If we are constantly trying to solve problems and find solutions through effective investigation of failures, do we ever consider that the best solution is to ignore the past and invent the future?  Those of us who have a wider view of what innovation should deliver seek entirely new approaches verses conventional problem-solving for cause.  It’s not that analytical thinking is unnecessary but on occasion, a new solution unrelated to cause removal is warranted.

What is Innovation and how is it Different from Creativity?

For most, creativity is coming up with a good idea.  Innovation is the process by which you conceive novel ideas and put them into practice.  Obviously creativity is of little value if you can’t put a new idea into practice.