Applied Clinical Trials-03-01-2010

REGULATORY : Rediscovering the Role of Regulatory Scientists CRO/SPONSOR : Trends in Clinical Outsourcing Language Lessons for Global Sponsors SITES : The ABCs of SOP Best Practices Also in this issue : FDA Works to Modernize Health IT System, Health Technology Assessment Brews in EU, Sizing Up the Clinical Research Market, Patients Tune In to Recruitment

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In-depth survey reveals trends, outlooks, and future plans of both sponsors and service providers.

Detailed instructions for creating strong SOPs that can serve as the backbone of studies and sites.

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

FDA is modernizing systems to better access data on drug effects, utilization, and safety.

Updates on the RA market, including Phase III study results and drug approvals, and related business news.

Clinical teams need to learn what motivates a patient to become a study subject.

EFGCP plans to simplify and improve the current system.

With clinical trials now a global industry, "back" translation requires a closer look.

Spending on research exceeds $35 billion, and clinical grant spending now tops $11 billion.

No one involved in clinical research is ever quite satisfied with the status quo.

There is a misalignment of experiences, expectations, and beliefs among subjects, investigators, sponsors, and service providers.

Drug evaluation criteria could soon include an intrusive health technology assessment.

To successfully bring a drug to market and keep it there requires the skills of regulatory scientists.

Systemized knowledge: experience, insight, and predictive modeling deliver successful enrollment.

Through digital signage, sponsors hope to increase enrollment in trials.

An intelligence-driven end-to-end approach defines new recruitment methods.