CDISC is meeting in Switzerland, and Fast Track Systems has participated in a demonstration project at the conference. Fast Track used its trial planning tool to populate several different electronic data capture systems with the same study protocol. Using the CDISC operational data model (ODM), the EDC systems then generated electronic case report forms. “This practical demonstration is a genuine milestone along the road to a fully integrated, structured information flow in clinical development,” says Ed Seguine, CEO of Fast Track Systems. “Open data standards can be used to transfer clinical trial data seamlessly between unrelated applications that were developed without collaboration by different vendors. Our TrialSpace Designer gave the instructions for collecting and representing clinical trial data to EDC systems from five different vendors. Stated simply, the data acquisition end of the integrated eclinical development environment is now a reality.”
Cytel, a provider of statistical services and software, and Tourtellotte Solutions, a provider of supply chain software, announced the integration of tcVisualize and FlexRandomizer. The new combination simulates both supply chain and flexible randomization for adaptive clinical trials. This simulation package is an essential requirement for the successful design and implementation of innovative clinical trials, including adaptive trials. A longer story, on this website, can be found here.
Impac Medical Systems, a provider of information technology solutions for oncology care, launched a new unified cancer registry product, Metriq. Impac users from regional, state and national cancer registries can now experience the benefits of Impac’s next generation cancer registry, including workflow management and data analysis features and benefits.
etrials, an eclinical suite, has recently signed three new contracts with its two existing customers to provide EDC solutions for oncology clinical studies. etrials will work with two existing pharmaceutical customers on three new studies. The first agreement covers 229 sites in the US involved in Phase I and IV studies. The second agreement involves 50 sites throughout the US in Phase II trials related to lung cancer.
ediary company PHT announced that Durect, an emerging specialty pharmaceutical company, selected PHT’s LogPad System to collect symptom and quality of life data from 50 patients in a Phase II post-herpetic neuralgia (PHN) study. The PHT system improved Durect’s ability to measure treatment benefits more accurately in the post-herpetic neuralgia trial.
Lilly is dealing with a damaging You Tube video made by a former sales representative. On the video, an unnamed but well-informed ex-Lilly employee outlines strategies for spinning clinical trial data and for dealing with the fact that the company’s anti-psychotic medication, Zyprexa, frequently leads to significant weight gain. One recommendation for patients seeking to avoid obesity: drink a large class of water before and after each meal. The video was developed by Pharmed Out, a physician-run, anti-industry group. The group’s funding, ironically, originates from industry: a settlement of marketing charges against Pfizer with regard to its Neurontin painkiller.
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