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…more...

What are the indispensable elements of an eclinical suite? What are the obligatory applications that any well-managed clinical trial will depend upon? Yes, electronic data capture (EDC). What about imaging? And ... drum roll, please ... drug supplies? Such questions are a bit more urgent in the wake of BioClinica buying…more...

If one wants to launch a study on a treatment for Type 2 diabetes, and one desires to know how long it will take to enroll patients in, say, Brazil vs. India, the avenues for obtaining that information have been limited. Not anymore. The consulting, benchmarking and analytics firm KMR Group has…more...

The sighting of an FDA official at the podium is one excellent reason to attend the annual Drug Information Association (DIA) meeting. It’s not that FDA officials say something new. (They’re trained not to.) Rather FDA presenters at industry conferences act as meta-anthropologists, explaining their own customs and cultural practices to…more...

Two hundred people. Yes, 200. A good-sized office building full of them. Their job? Toiling like modern incarnations of ink-stained Dickensian clerks. All day, they cut and paste data from one clinical trial management system (CTMS) into another. Why? So that senior managers can see printed reports that contain fresh, timely…more...

True story. An unidentified large pharmaceutical company calls up its contract research organization (CRO) with a question: "How many patients are enrolled in our trial?" After a few days of meditative silence, the CRO replied: "Let's have a meeting." A few days later, five well-dressed CRO executives appear at the sponsor's…more...

If paper is the sand in the gears of the 21st century clinical trial, money may be the wettest form of that sand. Getting funds to patients and investigators in an auditable, documented, transparent manner is no small thing. Generating a single paper check is easy. Generating hundreds or thousands of…more...

When the Institute for OneWorld Health goes to India to conduct a clinical trial, it bypasses heavily populated Mumbai or bustling Bangalore, where most global trials occur. Instead, OneWorld goes deeply rural—so rural that sometimes there's no infrastructure at all. But that's where its targeted diseases are. OneWorld Health is the…more...

In its April acquisition of Waban Software, Phase Forward picked up a specialist in clinical data repositories and data integration. It is the latest signal that, far from being intimidated by Oracle, Phase Forward intends to offer a similarly broad suite of products, the better to simplify the technology landscape for…more...

Say you need someone to do something for you in Singapore. It turns out it’s rude to leave someone a few voice mail messages. Even several email requests are a bit of a no-no. Instead, communication via so-called “text” or short messaging systems (SMS) is the norm and the Emily-Post approved…more...