Applied Clinical Trials-04-01-2012

INFORMATION TECHNOLOGY : Enhancing Risk Assessment and Mitigation REGULATORY : Sunshine Act?s Impact on the Industry Implementation of Objective Internal Monitoring Also in this issue : Impact of Transparency Policies, EMA?s Executive Director Faces Multiple Challenges, The Roles of Healthcare and Research, HIV Vaccine Trials

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

Demand for more information on study results and investigator payments create challenges.

Healthcare and research should pass useful information back and forth whenever possible.

PHACT is making inroads in drug development for neglected disease.

The EFGCP has organized a meeting next month in Trondheim, Norway, that will focus specifically on complex cases.

The amendment addresses data concerns for both physicians and drug/device manufacturers.

The new Executive Director of the EMA has managed to stay calm under financial and political pressure.

ERT and UCLA partner in postmarket studies with an eye toward telehealth.

A new service is launching at the end of the month that should help make recruitment easier.

A quantitative approach to enhancing risk assessment and mitigation in drug development.

Allison Burmeister discussed the average cost increase based on the per patient cost in a clinical trial during her presentation at the ExL Pharma C.R.O.W.N. Event.

TTC

There's a rapidly growing trend towards targeted (or risk-based) site monitoring and data review. However, some organizations remain concerned about the potential impact on data quality.

Sponsors are responsible for monitoring studies, patient safety, and data integrity.

Researchers who work on HIV vaccines face a major challenge: convincing members of at-risk communities to volunteer for these trials.

The benefits to virtual trials seem endless.