Applied Clinical Trials-07-01-2012

July 01, 2012

Cost inefficiencies in drug development are a major focus of discussion, especially with the many financial impacts affecting the pharmaceutical sponsors.

July 01, 2012

S

July 01, 2012

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

July 01, 2012

The percentage of source document verification coverage has been decreasing slightly over the past four years. Therefore, the amount of on-site time required by site monitors should also start decreasing.

July 01, 2012

Proposed rule changes on public information in Europe never make it to fruition.

July 01, 2012

Tufts CSDD

July 01, 2012

Biosimilars are a steadily growing new field of biopharmaceutical development and clinical research.

July 01, 2012

Analysis suggests age, condition, and treatment satisfaction have most significant effect on participation.

July 01, 2012

In August last year, the FDA came out with its Guidance for Industry Oversight of Clinical Investigations-a Risk-Based Approach to Monitoring. Sponsors and CROs alike are still examining the document and discussing how best to move forward.

July 01, 2012

Criticisms of the pharmaceutical industry's real motives for undertaking post-marketing studies have been made by a special report in the British Medical Journal.

July 01, 2012

The main result of the Supreme Court decision upholding the Affordable Care Act (ACA) is that it ends all the rampant speculation and uncertainty about the future shape of the US healthcare system.

July 01, 2012

Despite their growing role, little benchmark management data, until now, existed on global study monitors.

July 01, 2012

Prior to initiating a trial with ED sites, three factors must be considered in order to achieve success.

July 01, 2012

It's hard enough to conduct clinical trials for experimental medicines, but it can be even more difficult when patients already have access to the medicine outside the research setting.

July 01, 2012

Regulatory: Developing Biosimilars for a Global Market Subject Recruitment: Patient Interest in Clinical Trial Referral CRO/Sponsor: Functional Service Provider Model Also in this issue: Proposed Rule Changes in Europe Global Study Monitors Benchmarks Emergency Department Trials