Applied Clinical Trials-02-01-2012

TRIAL DESIGN : Enrollment is More Than a Numbers Game REGULATORY : Late Phase PK Collection Also in this issue : Protocol Design and Study Management, Effects of Europe?s Economic Turbulence, Ready for Big Data?, Outcomes Assessments

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The best relationships between sponsors and contractors are those that are well defined from the outset.

PPD has begun training its Clinical Research Associates in a virtual classroom.

Industry news focusing on the people and organizations who work in the clinical trials profession.

Europe's struggling economies may have unexpected effects on the pharmaceutical sector.

All measurements and outcomes need to reflect what is happening with the patient.

FDA wants sponsors to build quality into protocols, adopt risk-based strategies to streamline trials.

Five key pieces to a lasting and successful sponsor/CRO relationship.

PAREXEL's Neal Mantick discusses the strategic advantage of the transition from clinical research to commercial.

Pzizer's Craig Lipset answers questions about the ongoing REMOTE trial.

Vendors have developed systems for massive databases, but are we data ready?

Partnering with CROs and using a blinded independent central review can increase trial success.

A British Medical Journal survey suggests that misconduct in research is not going away.

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.