Expert View
How To Think About EDC
Bayer’s Rob Musterer discusses a little-appreciated aspect of any electronic data capture system.
Investigator sites accept the need for technology like electronic data capture (EDC). But they remain puzzled about why some problematic EDC solutions are selected by clinical trial sponsor firms that seem indifferent to the operational problems created by such systems. “Sponsors and CROs really need to think about this,” says Christine Pierre, CEO of the 16-year-old site network RXTrials, and founder of Site Solutions Summit. “Vendors shouldn't be chosen based on who had the biggest, glossiest presentation, but rather, what is their product like for the end user? Randomization goes back to the volunteer who 's waiting and waiting and waiting, and maybe even being sent away. Do we really want new trial subjects' first entree to research to go like this?” Sites have multiple concerns about EDC: There's no standardization around how data are recorded. Yes, the Clinical Data Interchange Standards Consortium (CDISC) has been developing standards. Some of those…more...
Electronic data capture (EDC) systems allow sponsors to gather data electronically. In theory, that should be cheaper and faster. After a decade of gradual acceptance of the technology, all sponsors have…more...
Is electronic data capture (EDC) creating inefficiencies? That's one conclusion to be drawn from the interim results of an eClinical Forum survey. …more...
Public or private. Contract research organization (CRO) or technology vendor. If a company specialized in supporting clinical trials, we considered it. It's no surprise: Quintiles is at the head of our…more...
Say you spent a lot of money on the latest and greatest electronic data capture (EDC) solution, and the software purveyors came out and set it up and put your staff through training for a day or two, and then ... shook your hand and disappeared. Now what? What to do about help-desk services? What if several…more...
Trio Clinical Research Management, a rare contract research organization (CRO)-staffing company hybrid, was going great guns. The company had a 95 percent client retention rate. It had no debt. Both sides of the business were booming. And owners Betsy Brown and Faye Woolf, friends since the 1980s, were happy as clams. Despite being named to Entrepreneur Magazine’s…more...
It had been a while. Years, actually. But Bruce Schatzman, president and CEO of Advanced Clinical Software (ACS) seems to be doing even better than we expected. He started the firm back in 1993. In our last conversation, published here a long time ago, he wasn’t too worried about Oracle. That proved correct. ACS never needed money…more...
Little is known. But what’s there is tantalizing. Parexel International has offered to buy ClinPhone. ClinPhone has rebuffed the overture for now. Matters may go no farther. A merger of the two firms, now hypothetical, would change the conventional wisdom about how services and technologies should be combined in clinical trials. A combination of Parexel and ClinPhone…more...
Bayer’s Rob Musterer discusses a little-appreciated aspect of any electronic data capture system.
Updating Central Coding for InForm, Phase Forward tries to simplify the management of vital dictionaries like WHO Drug and MedDRA.
The San Francisco firm discusses the difficulty of some of its projects and why it likes more experienced employees.
A leading CRO and trial technology vendor discuss how they work and communicate.
Hardly a gimmick, Nextrials’ use of the Apple iPhone could make overworked site staff and monitors like their jobs a bit more.
Technology will make new types of clinical collaboration more affordable, says DSG’s Tony Varano.
With appeal for academia and federally sponsored trials, the North Carolina firm has a solution that combines tools for collecting data and managing trials.
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