Safety. Efficacy. Are those two cardinal notions of clinical development enough? Jean Paty has a third. He believes it is as central as safety and efficacy. Paty is co-founder and senior VP of scientific, quality and regulatory affairs at invivodata, a Pittsburgh, Penn., electronic patient diary firm. If safety and efficacy are the X and Y axes…more...

Are patient-reported outcomes a growth industry? A business? Philadelphia's ERT apparently thinks so, having just paid $81 million for the clinical trial business of Carefusion. The purchase could increase ERT's revenue by 50 percent, to perhaps $150 million yearly. That would put it in the general ballpark of the sales at Parexel's technology division or …more...

After doing 20 trials together, Quintiles and ediary supplier invivodata announced a closer partnership. For the large contract research organization, the relationship likely brings additional scientific firepower to a research niche newly legitimized by a final FDA guidance document in patient reported outcomes (PRO). For the Pittsburgh ediary supplier, meanwhile, the relationship will bring more projects and…more...

The modern patient-reported outcome (PRO) study does not unfold in a vacuum. Whether launched via the web, a telephone interactive voice response system (IVRS), or a dedicated handheld device, most PRO projects rely on an army of external consultants and suppliers. Simple web- and IVRS-based PRO studies can handle only so much complexity, only so much branching…more...

Jeff Sloan is a professor of oncology and health sciences at the Mayo Clinic. His specialty is the quality of life of the cancer patient. Sloan has been involved in patient-reported outcome (PRO) research for years, in both academic and industry projects. “The science is progressing,” Sloan told a Center for Business Intelligence (CBI) symposium dedicated to…more...

For some sponsors, patient-reported outcomes (PRO) are one of many discretionary novelties in the repertoire of the modern clinical trial, optional curiosities that might be deployed. Or not. For all the warm speeches at industry events about patients "at the center" of modern clinical science, "at the heart" of every study, those phrases can ring hollow. A…more...

Picking the best clinical trial technology has always come with a price. The more technologies in the trial, the more difficult it is to link them. Some projects become so gnarly that sponsors defer or avoid using new, additional tools out of the sheer pain and fear over how to tie them into what they already have.…more...

Hey! Can you reset my password? Now? Inside or outside the clinical trial world, that is one of the most mundane and routine requests made to software help desks. Ediary firm PHT says the ongoing hassle has now been simplified in its StudyWorks system. The system has now been updated to allow users to administer their own…more...