Posts Tagged ‘Safety’

The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonisation “E2B” standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3), the latest version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard, includes new requirements with which product manufacturers and the organizations that […]

The deployment of business process management (BPM) strategies in a digital world revolves heavily around leveraging software platforms to automate pieces of or even complete processes. Whether you’re in clinical operations, safety and pharmacovigilance, or a back-office department, BPM technology solutions can be used to address virtually any business challenge that involves a process. Join […]

  In a time when the turnover rate for clinical monitoring positions in the U.S. hovers around 25%, it’s more important than ever to do more with less. With risk-based monitoring (RBM), contract research organizations (CROs) and sponsors can leverage data in existing IT systems to spot, rectify, and prevent issues related to the execution […]

  In less than a month, Oracle will be hosting Oracle Health Sciences Connect Europe, a free event that is geared towards users of Oracle’s life sciences applications, as well as partners of the software company. The one-day meeting will take place on March 22, 2016, in London and will provide information on product roadmaps, […]

  We’ve been getting a lot of requests, lately, to help companies decommission their old GxP systems. The systems were once validated and still contain GxP data that might someday need to be reviewed or analyzed, but they’re no longer being actively used. They’re just sitting there, taking up server space, undergoing basic IT maintenance, […]

  Over the last decade, the life sciences industry has gone from running clinical trials on paper or, in many cases, in Excel, to leveraging comprehensive web-based systems, such as electronic data capture (EDC) and clinical trial management systems (CTMS). But, in more recent years, the widespread use of mobile technology has enabled even more […]

  This struck me as interesting: The Boston Globe wrote an article on how doctors at Brigham and Women’s Hospital (BWH) are encouraged to share medical errors. In fact, they are asked to do so, knowing that the information will be published in a case study-like format for the public to see. The objective is […]

  Wow, it’s not often you hear about executives from life sciences companies getting jail time. But in the case of the former CEO of OtisMed, that’s just what he got: two years and a small fine. The company also agreed to pay more than $80 million to resolve other charges. Without receiving FDA approval, […]

  I recently stumbled upon the picture on the right on LinkedIn and it reminded me of a conversation that I had with my mother, who is an architect by trade. She told me that many roads came to be what they are today, not by well-thought-out plans, but rather by people and animals getting […]

  Throughout 2015, we should continue to see life sciences companies investing in technology to reduce drug and device development costs and time, and more importantly, to improve the safety and efficacy of their products. It’s no longer a choice, but rather a matter of time: life sciences companies need to upgrade their IT solutions […]

Quit with the boring pharma TV ads. I can’t remember the last time I saw one – well – that I remembered. Until now, out of the red corner…Valeant. Just imagine the jubilation Valeant is feeling right now. Alright, I’ll stop with the wordplay – at least until the middle and maybe the very end! […]

A couple of weeks ago, a client of ours discovered a problem in the production (PROD) environment of one of their clinical systems. In the initial system implementation, they had opted for a single environment (without a sandbox, development, training, test, or validation environment), so they found themselves with no separate environment in which to […]