Successful Clinical Trials Management - Pharmaceutical Executive

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Successful Clinical Trials Management

Building Common Knowledge to Get Results

June 1, 2005

A leader can reframe a situation. By recognizing that her own perspective may be incomplete, the leader can expand her frame to include more options for action than simply repeating herself.

Protecting Privacy and Encouraging Research

June 1, 2005

If a physician wants to use protected healthcare information (PHI) for research purposes, particularly if the PHI is going to be published as part of research results, an authorization or waiver will be required.

Dear eDiary

June 1, 2005

Electronic patient-reported outcomes tools let trial sponsors enforce recording deadlines and compliance. They help keep subjects honest.

Tools Are Just the Beginning

June 1, 2005

Pharma companies are committed to using electronic data capture in clinical trials. Technology adoption will continue to grow, as FDA and consumers want faster safety data.

Ignorance is No Excuse

June 1, 2005

State clinical trials requirements are in place to protect people from being exploited, or unsafely exposed to compounds. Forty years later, it's easy to say, "How did this happen?"

QT Prolongation: Closing in on the Target of Meaningful Data

June 1, 2005

A prolonged QT interval creates an electro-physiological environment that is favorable for the development of cardiac arrhythmias.

Potential for Abuse

June 1, 2005

All too often, abuse liability and dependence potential are afterthoughts in the drug development process.

Untying the Outsourcing Knot

June 1, 2005

Pharma trial sponsors and their CROs should enlist the support of high-level executives to make sure designated decision makers are fully confident in their ability to act.

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