Applied Clinical Trials-03-01-2012

Clinical professionals can recreate CTMS by applying modern technology in a new way.

INFORMATION TECHNOLOGY : Revolution in Randomization Clinical Database: Proper Coding and Design Also in this issue : PDUFA Renewal, EFGCP Meeting on Informed Consent, Drug Development Cycle Time, Choosing an eClinical Solution

Congress, industry map out goals and concerns for revising FDA policies linked to user fee legislation.

The FDA issued guidances in February that outlines its recommendations for developing and approving biosimilar therapies.

Medidata

The clinical trials industry can benefit from site-driven metrics for process improvement and site scoring.

Obsession with shorter cycle times has been mistakenly drilled into all aspects of development.

One of the biggest obstacles to Alzheimer's research is recruitment and retention.

European Forum for Good Clinical Practice meeting on informed consent draws a huge crowd.

The European Patients' Academy on Therapeutic Innovation faces its first major test during the 2012 Drug Information Association EuroMeeting.

Joseph Kim discusses a recent patient panel he moderated.

Systems that support automated processes have begun to transform the conduct of clinical trials.

Positive patient experiences can help drive late phase study success.

Choosing eClinical solutions can appear to be a tricky situation.

TTC

Cover

Proper questionnaire coding and design can help set the stage for a successful trial.

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