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December 3, 2008
Are there any diary trials for which paper-based data collection tools are appropriate?
Twenty years after they began making diaries, Saul Shiffman and Jean Paty of invivodata talk about the industry niche they helped to create.
Ranbaxy is planning to buy a contract research organization (CRO) that would be a component of a new R&D subsidiary. The CRO would be part of a partially owned R&D division to include Ranbaxy’s ongoing collaborative programs with GSK. Ranbaxy…
Covance, a biopharmaceutical drug development services company with global preclinical and clinical research operations, has appointed Hani S. Zaki to the position of vice president and general manager of its periapproval services. Zaki will be responsible for managing large research…
It’s not exactly a news flash that there are major problems with paper patient diaries in clinical trials. Let’s just take two massively important problems: Patients don’t fill out paper diaries when they say they do. And there’s no need…
invivodata is one of a select number of firms—along with Arrowhead, CRF, PHT, and Symfo—specializing in handheld electronic diaries to record patient experiences in clinical trials. At the 2007 annual Drug Information Association (DIA) meeting, ClinPage chatted with invivodata founders…
On the eve of the Drug Information Association (DIA) meeting next week, ClinPhone announced ClinPhone Compact. It’s a web-based tool, using the telephone and the internet, to manage patient randomization and drug supplies. To use the jargon, Compact is both…
PharmaVoice and TNS Media Intelligence are sponsoring a free webinar on marketing in the age of anti-industry publicity. The session is on June 20th, 2007 at 2:00 p.m. Eastern. Titled “Surviving the Election Wars: Strategies to Build Trust and Protect…
The FDA is relaxing its guidance for computer systems in computer trials. 21 CFR Part 11 enforcement will be more “discretionary.” We’ll be writing more about this. For now, here is an excerpt from the new document: “This guidance finalizes…
Reston, Virginia’s PICS offers professional research software called Certas. PICS is charging a very reasonable $1,200 for Certas as the introductory price for an academic study with 30 participants. Larger projects might range as high as $30,000, depending on the…
The majority of electronic patient-reported outcome data (ePRO) in the pharmaceutical industry, we would venture, are collected on devices and software running on Palm. That’s a reflection of the industry’s assessment of Palm’s superior design. They are superbly easy devices…