March 20, 2010
| eCliniqua > Regulatory & Safety



Industry Trends

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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



Regulatory

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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.

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.”

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.

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.

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.  

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.

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.

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.

White Papers & Special Reports

oracle_clinical
eClinical Visions - Clinical Trial Management: Enabling Operational Efficiency
Sponsored by Oracle

Read how contributors from Genzyme, Duke Clinical Research Institute, Accenture, Oracle Health Sciences and others address some of the most pertinent challenges facing the biopharmaceutical industry including... Globalization of clinical trials driven by the need to reduce costs and recruit participants; greater outsourcing; escalating regulatory demands; increased trial complexity; and post-marketing studies. Download this paper to gain new insight into:

  • Recent progress made in addressing these challenges
  • Expert opinion on clinical trial management systems (CTMS) for improving trial efficiencies
  • How to cut trial costs and enhance the productivity of trial participants


oracle_RDC
Remote Data Capture – Acquisition and Analysis
Sponsored by Oracle

Today nearly half of all clinical trials are conducted electronically, and rising! Electronic Data Capture (EDC) technology provides industry-wide opportunities, along with challenges, that are being addressed. In this informative report industry experts and users from Pfizer, PPD, C3i and Oracle Health Sciences discuss the impact of EDC and its newest zero footprint; online iteration.  It can used anywhere, world-wide, where the Internet is available while placing greater onus on global trial support. The critical focus of this new technology is that it must support the work of the person at the heart of the clinical trial system– the investigator. Download this report to learn more about:

  • Trends and Issues in an Electronic Clinical Data Management World
  • The New Remote Data Capture Paradigm 
  • Improving and Monitoring Clinical Data Management in the eClinical Age
  • Optimizing and Supporting Remote Data Capture


oracle_video
Technology Video Report: A Day in the Life with Remote Data Capture (Next-Gen EDC)
Sponsored by Oracle
See why Oracle Remote Data Capture (RDC) Onsite is the next generation in electronic data capture with its user-friendly method to collect, clean, review, and verify clinical trial data. Providing unprecedented performance with real-time data capture, Oracle RDC Onsite simplifies source data verification. With a clear, consistent view of study data across all sites, the benefits include reduced monitoring time, decreased queries and discrepancies, and less time to database lock.



Life Science Webcasts & Podcasts

Predict or Perish! Shaping the Practices of Clinical Trials
Decisionview webinarSponsored 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

Job Openings

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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