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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The Reality of Medical Software Compliance
Jan 19 | Expert Commentary | “It is estimated that 60% of the computer systems containing patient medical records currently in use within the United States are not in compliance with the industry standards for security, audit trails, and electronic signatures,” states industry expert David Nettleton, FDA Compliance Specialist, of Computer System Validation.
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Peddicord: New Privacy Concerns with ‘HIPAA 2’
Jan 4 | eCliniqua | A new set of federal privacy and security requirements, introduced by legislation promoting the adoption of electronic health records (EHRs), “may make the investigator-CRO interface more complicated for some time.”
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Adverse Event Reporting Begins at Clinicaltrials.gov
Sep 21 | Starting on September 27, sponsors of industry-, academic- and government-run clinical trials will have to begin reporting adverse events on www.clinicaltrials.gov.
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BioClinica Acquires Tourtellotte Solutions
Sep 21 | BioClinica has acquired Tourtellotte Solutions, best known for its supply chain simulation and interactive voice (IVR)/interactive web (IWR) software.
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Will Regulated Product Submission (RPS) Trump eCTD?
June 26, 2009 | Just as the electronic common technical document (eCTD) is gaining traction as the required format for electronic regulatory submissions, the FDA is changing the game.
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Phase Forward Helps FDA, DoD Monitor Drug Safety
eCliniqua | The Department of Defense last year chose Phase Forward’s Lincoln Safety Group to support a new drug safety initiative, enabling it to provide the FDA with rapid assessment capabilities.
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Workgroup Sets Priorities to Harmonize Standards for EHRs and Research
eCliniqua | The much anticipated convergence of data between clinical trials and electronic health records (EHR) is heading toward reality with the recent formation of the EHR Clinical Research Value Case Workgroup.
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Etrials Purchase Would Make BioClinica Number Three EDC Player
May 8, 2009 | What reputable products and a succession of management teams couldn’t do for etrials Worldwide its soon to be owner most likely can boost stagnating sales and stem the red ink.
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The Workflow Driven Lab Many companies have recognized that their internal business units operate as a set of business processes. These business processes are also called workflows. Modern Laboratories are highly suitable to this workflow driven approach. In fact, the lab environments successful operation is predicated on the successful definition and adherence to workflows. It could be said that a modern laboratory is an advanced process implementing construct. It is important that laboratory management software mirrors the process driven nature of the lab thereby increasing automation, shortening learning curves, improving data quality and increasing lab throughput. - The modern laboratory is an advanced workflow implementing construct
- Laboratory Management Software solutions should fully embrace and mirror this process driven approach
- Effective information management of workflow processes with a LIMS results in increased automation, reduced training curves, better data quality and increased lab throughput
Curing Life Sciences Data Management Challenges with Scalable Storage High performance storage systems are a given to meet today’s life sciences R&D computational challenges. But with the explosive growth in data produced by next-gen lab equipment, scalability and long-term data management issues must also be addressed. Read this paper to learn: - Why new lab equipment will impact R&D workflows
- How to avoid the hidden costs of long-term data management
- What approach you should take to accommodate today’s data while having the flexibility to scale to meet future demands.
StorNext 4.0: Technical Product Brief
Proven in the world’s most data intensive industries, Quantum StorNext is a scalable, high-performance file system which allows data sharing across Linux, Mac, Unix, and Windows operating systems and manages data in enterprise storage environments. In this Technical Brief you'll learn: - How a high-performing file system can accelerate your business
- How to simplify your data management
- How a tiered storage approach can save you money
Predict or Perish! Shaping the Practices of Clinical Trials
 Sponsored by: DecisionView
Predictive Analytics are a key differentiator in running your clinical trials successfully through 2010 and beyond. They will help you to optimize your patient enrollment, reduce your clinical operations costs and minimize your financial liability in the clinical supply chain. In this session, you will:
• Learn what predictive analytics are and what they are not
• Understand why you need predictive analytics to run your clinical trials, and
• Explore how predictive analytics will shape the future of clinical trials
Download Now.
More Podcasts
The University of Washington Department of Genome Sciences is seeking a LINUX SYSTEMS ENGINEERING MANAGER to lead a team in a diverse scientific computing environment that includes multiple HPC systems, petascale storage, and custom application servers. Apply online at UW Hires for req number 61505. http://www.washington.edu/admin/hr/jobs/
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