Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials
By Mark P. Mathieu For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore. Read More
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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. more 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. more May 11 | News Brief | This week, National eHealth Collaborative (NeHC) unveiled NeHC University, a revamping and substantial expansion of its NHIN University program. more May 4 | News Brief | ClearTrial is in the list of "Cool Vendors" in the "Cool Vendors in Life Sciences, 2011" report by Gartner. more 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. more 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. more 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. more 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. more 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. more 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. more
Meeting Today’s Challenges in Clinical Trial Supply Management Sponsored by: Medidata Solutions Worldwide
Setting up and managing the clinical trial involves many complex procedures. Among the most challenging are planning and executing the logistics of the trial’s clinical supplies. This podcast focuses in depth on the following topics which trace current practices and future evolution of this crucial aspect of clinical trials:
- Current practices in clinical trial logistics
- Comparing advances in clinical supply practices to other aspects of clinical trials
- Where current practices fall short of meeting the challenges
- Trends and evolving improvements that may change the way logistics are conducted
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New Drug Development:
A Regulatory Overview
An authoritative reference book that addresses the most cutting-edge developments redefining how new drugs are developed and regulated today. New Drug Development is pharma/biotech’s “go-to” resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA’s drug development approval processes. View book details here.
Bio-IT Weekly Update
eCliniqua
Next-Generation Sequencing Technologies: Applications and Markets Report Author: Ken Rubenstein, PhD
Next-generation sequencing (NGS) has taken the worldwide biomedical research community by storm. Funding is relatively abundant for the moment, collaborative programs and consortia abound, and early results in many cases appear to justify all the activity. Many observers sense imminent new revelations and even paradigm shifts offering significant improvements in the understanding and treatment of disease. Download Brochure and Order
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