News

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.

To judge the value of process improvement, companies need to understand the cost of doing business. The problem is: they don?t.

An attorney who specializes in health law advises researchers and research organizations to study and put into practice the proposed changes in a rule that governs use and disclosure of protected health information.

Readers respond to articles and editorials.

As clinical trials become global affairs, more effort should be devoted to the protection of research subjects. However, the question of consistency among ethics committees looms.

In a global survey, Roche asks investigators how to go about getting the best clinical trial sites.

The European Forum for Good Clinical Practice (EFGCP) put together these guidelines as a push toward quality and efficiency in ethical review practices.

In Europe, U.S. CROs aren?t doing as well as they could. Where they locate their offices could make the difference.

Readers respond to articles and editorials.

Improving adverse event reporting can lead to improved safety profiles and, consequently, fewer drugs pulled from the market.

Family man, educator, mentor, athlete--and a man on a quest with Amgen Inc for new and better oncology treatments.

A new method, based on hard-earned experience, can help you reduce the risk of protocol inconsistencies and ambiguities during the protocol development process.

The pharmaceutical industry spends more than $156 million each year to support data transfer, and all involved parties could benefit from common interchange standards.

Many re-engineering projects neglect the nuts and bolts that are needed to make strategies a reality.

Technology can do only so much; understanding human behavior and psychology is the key to improving your communication skills.

An essential aspect of selecting the location for an investigative site is the population surrounding it. Here is a method for determining how many potential subjects are available to your investigators.

Through open discussion and dialogue, and by promoting understanding and trust, Crawley?a longtime member of the European Forum for Good Clinical Practice?champions ethical research.

9th ACT European Summit

The system is an important part of the selection equation in CEE nations where sponsors must contract with institutions rather than investigators. Examples from Hungary offer guidelines for improving selection SOPs.

Readers respond to articles and editorials.

Clinical trial samples can be dangerous or infectious. With regulators and airlines cracking down, you should know the rules for their transfer and transport.