Articles

Successful electronic transmission of information relies on the definition of common data elements and standard transmission procedures. However, until electronic reporting becomes mandatory it is unlikely that all companies will participate…

Patient recruitment is one of the industry's greatest problems. A recent article claimed that greater than 50% of delays are attributed to patient recruitment and 30% of investigator sites fail to recruit a single patient for a study…

In the past, there was often time within a traditional product development program to generate useful data to enhance market penetration. But now, the emphasis is on speeding products through the development process to market in order to realize a revenue stream as early as possible. Consequently, more is being asked of individual clinical trials, both pre- and post-approval to fulfil both development and marketing needs...

The globally integrated CRO is about to undergo significant change driven by challenges from small, next generation CROs which, for the first time, are able to offer all the advantages of global reach with none of the disadvantages emanating from their small size...

The challenge facing the pharmaceutical industry is the need to transform data into effective information and susequently translate this into knowledge with which to make effective and timely strategic decisions…

The probity of pharmaceutical research is called into question as medical journal editors justify their new editorial policy on publishing clinical trial data…

The pharma and biotech industries have seen tremendous growth over the past decade, as hundreds of new products have left the pipeline and entered the marketplace. However, the paper-based clinical trial process has become very burdensome and the FDA is now taking much more time to approve drugs...

Open any industry publication and a glance at the myriad of advertisements promoting e-trial software confirms that we are in the midst of a revolution in the availability of software solutions for data capture and clinical data management tailored specifically to our industry. ...In this whirl of electronic activity, the most common question related to e-trials is - is your system validated?...

Over the past few decades, a great deal of time and money has been invested in raising the quality of clinical trials in Western investigational sites. Ideally, the industry can continue to recruit most patients from these traditional sites, but to do so requires a more thoughtful approach to patient recruitment...

The central issue is whether the extended timelines and cost of drug development represent difficulties and complexity inherent in the process or that they reflect inefficiencies amenable to improvements. Lessons from other industries, some considerably more competitive, suggest that technology has been under-utilized by the pharma industry and may profoundly change development cost and timelines...