The project manager’s lot in life is not always glamorous and filled with the drama of a James Bond movie. But as with any job in any industry, the project manager’s role in clinical trials has unappreciated complexities that make the role especially indispensible in multi-year projects orchestrated by multiple organizations. Some of the sessions at the…more...

Large life science companies have fired untold tens of thousands of employees during every year of the ongoing downturn—a period of both financial chaos and pharmaceutical mega-mergers. Here's one estimate, and another. Yesterday, having digested Schering Plough, Merck announced it would terminate 15,000 people and close eight research locations. Which doesn't mean the research industry is devoid…more...

Not all that long ago, shippers of drug supplies for clinical trials were content to know: Did our drug ship? Then they wanted to learn: Did our supplies get stuck in Ukrainian customs—or at the depot? Now Almac Clinical Services is offering another level of detail, allowing sponsors to hop online to learn How long did DHL…more...

With myriad industry efforts to accelerate study start-up times, one might think the process of hammering out contracts at the site level would now be speedier than, say, three years ago. Wrong. The trends are worsening. According to a new study by consulting, benchmarking and analytics firm KMR Group, the time it takes to get a site…more...

The drug development industry has spun its wheels for years, trying to come up with universal metrics to measure speed and efficiency. But metrics that accurately measure quality in a trial? No one has attempted that yet. Until now. The Metrics Champion Consortium (MCC), a non-profit collaborative effort of sponsors, contract research organizations (CROs) and vendors, was…more...

Are clinical trial professionals tracking the right metrics? Do any metrics matter, given that every company has its own quirky list—and that no list corresponds to other firms in the industry? Are there any metrics that should be granted early retirement? Or should the industry be tracking more? Ken Getz, senior research fellow at the Tufts Center…more...

Lean sigma. Six sigma. Lean six sigma. They are buzzwords in the pharmaceutical and contract research organization (CRO) industries, with executives tossing around “black belt” and “green belt” references at conference cocktail parties like so many half-eaten hors d'oeurvres. But what is it exactly? How do you do it? And does something from 1980s, from the manufacturing…more...

Is electronic data capture (EDC) creating inefficiencies? That's one conclusion to be drawn from the interim results of an eClinical Forum survey. Surprisingly, the survey suggests that the use of paper case report forms (CRF) is rising even amid growing adoption of EDC. While most sponsors are committed to EDC, site staff believe it is forcing them…more...