News

Good organization and technological support are needed to bring the benefits of electronic data capture to a clinical trial.

The results of a Web-based survey of some subjects in recent clinical trials suggest ways to improve the consent process.

A survey of pharmaceutical manufacturers reveals that pediatric trials are widespread across Germany.

Our 10th annual guide to applications highlights software, Web-based solutions, and more.

Paul Bleicher examines the pros and cons of broadband Internet technology and explains how to build a home network and make it secure.

Putting staff training at the bottom of your list of important tasks is a self-defeating attitude in the business world.

Integrating IVRS with in-house clinical trial management solutions can provide a powerful project management tool.

Bert Spilker has been involved in clinical trials for 30 years. He?s written books, founded companies, and helped steer regulatory agencies. Now he wants to change how drugs are developed.

Some companies prefer live training for PIs; some are moving toward virtual training. Two Lilly authors advocate a combination of the two methods.

Modern radiological techniques and digital analysis technologies permit rapid evaluation of the efficacy of oncology drugs. Continual review of methods detects flaws promptly, creating the opportunity to take corrective steps.

A set of trials carried out by the Collaborative Ocular Melanoma Study Group at eye centers throughout the United States and Canada led to improvements in the care of patients with choroidal melanoma.

Experts discuss the use of subject diaries and the way researchers can comply with applicable regulations and guidelines.

The European Organisation for Research and Treatment of Cancer is dedicated to improving cancer treatment in Europe. Its Regulatory Affairs Unit provides important services to researchers.

Adaptive interim analysis may allow smaller sample sizes when a drug?s clinical effect is unknown.

Readers like Lynn Sadowski, a senior clinical research associate at Sention Inc., share their experiences.

After years of pilot trials, the pharmaceutical industry still sees EDC as something new. Here are two approaches toward making EDC into business as usual.

Support can be key to a successful EDC clinical trial. These suggestions may help your organization achieve a better experience with EDC.

Commitment, skill, leadership, a clear focus, performance metrics, and a proven process will keep your cross-functional team from dysfunction.

Readers write in with questions and comments about articles and editorials.

Everybody wants faster cycles and and quicker turnarounds with NDAs. In the U.S., will it soon be possible to go from testing to approval in 1000 days?

Studies show that electronic diaries get better results than paper diaries. These authors explain why.

Successful pediatric research requires partnership between the pharmaceutical industry, investigators, ethics committees, and parents.

Readers respond to articles and editorials.

Both the pharmaceutical industry and regulatory authorities worldwide have recognized the need for more clinical studies in children. A recent European conference addressed the issues.

In Japan, pediatric clinical trials face obstacles, but new regulations give manufacturers incentive to conduct them.

At work and play, he?s devoted to children.

The United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?

European inspectors are doing a better job of implementing ICH GCP guidelines than their American counterparts at FDA. Here are 10 ways U.S. inspectors could improve their inspection process.