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Cetero Responds to FDA Letter
eCliniqua | On Wednesday, one day after the FDA issued a letter accusing CRO Cetero of "significant violations" at a Cetero facility in Houston, the company responded in a letter on its website.
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Trial Finder Launched for Parkinson's Trials
July 18, 2011 | The Michael J. Fox Foundation for Parkinson's Research has launched a Web-based solution to connect patients with Parkinson's Disease clinical trials. The beta version of the Fox Trial Finder (www.foxtrialfinder.org) compares volunteer information such as location and medical history with trial eligibility requirements to find the best potential matches at study sites nearby. The service matches both people with Parkinson's and control volunteers with the trials that need them.
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DIA 2011—Compliance, Collaboration and the Cloud
By Ann Neuer July 13, 2011 | CHICAGO—This year’s annual DIA meeting featured hundreds of exhibitors and session topics ranging from patient recruitment to cloud computing to improving regulatory reporting. There were several overriding themes including the continuing march towards
Jul 13, 2011
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Using Interim Analyses to Improve Efficiency in Drug Development
Jun 3 | Guest Commentary | Interim analyses offer companies the opportunity to stop studies early when it appears the primary objective will not be achieved or halt trials when there is clear evidence that the primary objective has already been met. This not only lowers costs but also speeds up the time to develop the compound, which obviously benefits both the company and patients.
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Euphoria over EHR/EDC Interoperability May be Misplaced
May 16 | eCliniqua | Despite noble efforts by the Clinical Data Interchange Standards Consortium (CDISC) and others to write a rulebook for the exchange of patient-level clinical information between electronic health records (EHRs) and electronic data capture (EDC), interoperability between the two systems is largely a pipe dream.
May 13, 2011
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MD Anderson Chooses Velos eResearch
May 13 | News Brief | MD Anderson has signed an agreement for an enterprise-wide installation of Velos eResearch for use in clinical trials. The installation is underway now and should be in use by 2012.
May 13, 2011
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eHealth University Unveiled
May 11 | News Brief | This week, National eHealth Collaborative (NeHC) unveiled NeHC University, a revamping and substantial expansion of its NHIN University program.
May 11, 2011
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ClearTrial Named Cool Vendor
May 4 | News Brief | ClearTrial is in the list of "Cool Vendors" in the "Cool Vendors in Life Sciences, 2011" report by Gartner.
May 3, 2011
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Inaugural Study of Lung Cancer Medical Institute Enrolls Patients
May 4 | News Brief | Biodesix has announced the enrollment of initial subjects into CASTLE, the inaugural study of the Addario Lung Cancer Medical Institute. The study collects biospecimens and data from lung cancer patients in order to facilitate and accelerate the development and delivery of diagnostic tests.
May 3, 2011
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RxTrials, Integra Enter Partnership
Apr 28 | San Antonio Business Journal | Integra Clinical Research and RxTrials have entered a partnership that will allow Integra to become a partner research site with RxTrials.
Apr 28, 2011
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Lilly, Medtronic Enter Parkinson's Collaboration
Apr 26 | News Brief | Eli Lilly and Company and Medtronic have entered into a collaboration to research and develop a new approach to treating Parkinson’s disease that involves delivering a potential new medicine to the brain using an implantable drug delivery system.
Apr 28, 2011
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Perceptive Relases Adaptive Trial Survey
Apr 28 | Outsourcing Pharma | Perceptive Informatics has released the results of a recent global survey thats shows a growing interest in adaptive trial design. During a recent webinar presented by Perceptive and Tessella, more than 300 industry professionals answered questions about implementing adaptive trials.
Apr 28, 2011
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Oracle Software Supporting Moffitt’s Personalized Medicine Ambitions
Apr 28 | eCliniqua | Moffitt Cancer Center recently announced that it selected Oracle Health Sciences solutions as the foundation for its next-generation health and research informatics platform. The groundbreaking partnership will support efforts by Moffitt’s longitudinal research initiative Total Cancer Care (TCC) to supply doctors of the future with a bedside decision-making tool for better matching patients to trials and treatments.
Apr 28, 2011
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Little Israel—Big in Clinical Trials
Apr 18 | eCliniqua | Israel, a small country of seven million, often described as the size of New Jersey, has emerged as a clinical trials powerhouse. With its highly skilled workforce, widespread adherence to good clinical practice (GCP), and strong patient enrollment rates with relatively few lost to follow-up, global life sciences companies view Israel as a key clinical trials destination.
Apr 6, 2011
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Batter Up: A Stratified Approach to Rheumatoid Arthritis
Apr 7 | eCliniqua | Mark Curran, senior director of immunology biomarkers at Centocor R&D, joined the organization five years ago and was tasked with a broad mission: to supply biomarkers to various compound-development teams and discovery R&D at Centocor R&D. Curran spoke with Bio•IT World managing editor, Allison Proffitt, about his vision for stratified medicine at Centocor R&D and the new Biomarkers of Anti-TNF Treatment Efficacy in Rheumatoid Arthritis-Unresponsive Populations (BATTER-UP) consortium announced in November.
Apr 7, 2011
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GSK to Implement Medidata Designer
Apr 4 | News Brief | GlaxoSmithKline has decided to implement Medidata Designer, an innovative study design optimization solution, for its Clinical Research and Development organization.
Apr 1, 2011
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ICON Grows AsiaPac Business
Apr 1 | News Brief | ICON has announced more growth in Asia Pacific, opening a new office in Shanghai, China, and also relocating its Beijing operations to larger premises.
Apr 1, 2011
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goBalto’s Three Easy Steps to Study Startup
Mar 30 | eCliniqua | goBalto's Tracker aims to reinvent the clinical study startup process.
Mar 30, 2011
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Perceptive Releases Survey Results for Designing Clinical Products
Mar 25 | News Brief | Perceptive Informatics has announced results of a survey conducted during its recent webinar entitled "Designing and Delivering an eClinical Product Suite."
Mar 25, 2011
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Putting Medical Records Data Through its Paces
Mar 23 | eCliniqua | The Partnership to Advance Clinical electronic Research or PACeR (www.pacerhealth.org) was created to “convene the users and the collectors of the data to understand how we can safely reuse electronic medical record data to facilitate clinical research,” explains David Krusch, chief medical information officer at the University of Rochester Medical Center and chair of the PACeR leadership committee.
Mar 20, 2011