News Briefs - August 4, 2008


Datafarm Inc., a provider of electronic document publishing solutions and regulatory submissions services for the life sciences industry, announced the availability of eCTDViewer Web Edition 4.0.1, a web-based viewing application that can be used as a primary and/or secondary viewing tool for electronic common technical document review. eCTDViewer Web Edition is scalable and appropriate for companies of all sizes. It makes use of industry-standard web browser applications, such as Microsoft Internet Explorer or Firefox. End-users can be assigned permissions to review eCTD and Non eCTD Electronic (NeES) submissions from anywhere in the world.  Read the press release.

Adlib Software, a provider of server-based document conversion and publishing software, and Lorenz Life Sciences, a provider of electronic submissions software, have signed an OEM agreement under the terms of which Lorenz will license and embed Adlib’s ExpressConversion technology into future versions of Lorenz’s docuRender for MS-Word product. The companies expect this technology integration to eliminate submission quality concerns and automate and streamline regulatory publishing with submission-ready PDFs delivered through Lorenz’s docuBridge submission management solution. Read the press release.

Kestrel Consultants has expanded its service offerings to include evaluation of customers’ existing standards use and recommendations to ensure:  compliance with CDISC, CDASH, and SDTM structures; consistency and completeness of electronic case report forms, edit checks, databases, and protocol/SAP/CSR templates; and consistency within or across therapy areas or the entire clinical development organization. Kestrel also designs centralized standards management and governance models for customers’ environments to track standards use, and to allow evaluation of standards return on investment.

Sparta Systems Inc., maker of the TrackWise enterprise management software, has furthered its market expansion in Europe with the addition of several new pharmaceutical and biotech companies to its roster of TrackWise customers.  These organizations will deploy the company’s TrackWise to support their globally dispersed operations in complying with government regulations, while streamlining overall process efficiency.  New European customers recently added to Sparta’s base include: Boehringer Ingelheim; Helsinn Healthcare SA; MED-EL Medical Electronics; ICON; and URSAPHARM ArzneimittelGmbH & Co. KG. Read the press release.

 

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White Papers & Special Reports

Waters white paper image
Software Helps Doping Control Lab Streamline Results Management
Sponsored by Waters
The Karolinska University Hospital’s Doping Control Lab tests thousands of samples annually for stimulants, diuretics, and other masking agents. Increased regulatory pressure and new technologies increased the number of samples analyzed creating data management challenges. Waters® NuGenesis® Scientific Data Management System and TargetLynx™ Application Manager software were used to reduce the time required to calculate, review and search results.


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Managed Innovation, Assured Compliance
Sponsored by SAS
Discovery organizations are identifying a lot of promising compounds, but clinical research processes haven't kept pace with timely testing of all those potential therapies. This white paper describes how SAS® Drug Development supports true innovation across the clinical trial process.

In this white paper you will learn how to:

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Addressing Life Sciences Constantly Growing Data Challenges Research Environments
Sponsored by BlueArc
The continued explosion of raw experimental data, the increased use of video, the growing adoption of new data retention practices, and the move to high throughput computational workflows are all placing new demands on the way life sciences organizations store and manage their data.

Download this white paper to learn about:

  • Factors driving the data explosion in the life sciences
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Life Science Webcasts & Podcasts

Medidata Solutions

Rising Clinical Trial Delays and Costs - Addressing the Cause, Not the Symptoms 

medidata podcastProtocol complexity is taking a toll on clinical study speed and efficiency: increasingly complicated and ambitious protocols are not only burdening sites and study volunteers but are also prolonging trials and increasing expenses. In response, sponsors have turned to global study placement, restructured site relationships and new site management practices, but the problem remains.

This podcast will discuss:

  • Why these responses address only the symptoms, not the underlying cause, of rising clinical trial delays and costs.
  • Results of a recent joint Tufts University / Medidata Solutions study.
  • New metrics benchmarking protocol design trends.
  • Systematic protocol design improvements and why they are essential to clinical trial performance excellence.

Speakers: Ken Getz, Senior Research Fellow at the Tufts Center for the Study of Drug Development, and Ed Seguine, General Manager, Trial Planning Solutions at Medidata.

Download Now 



More Podcasts

Job Openings

Director, Center For Information Technology (CIT) - National Institutes of Health  (NIH), Department of Health and Human Service
Located in Bethesda, MD. This position requires:
• High-level vision, leadership, management, and modernization of CIT programs and services.
• Strategic direction and policy development for CIT long-term operations and objectives.
• Serve as a key IT advisor to the NIH Chief Information Officer.
A TOP SECRET security clearance will be required.  More job detail is found at:  http://www.jobs.nih.gov under the Executive Jobs section.Or contact Ms.Winnie Garner at seniorre@od.nih.gov.  Applications must be received ELECTRONICALLY by (11:59 p.m.), December 17, 2008.  DHHS and NIH are Equal Opportunity Employers

Bioinformatics Manager- Lilly Singapore Centre for Drug Discovery
For more information click here 

For reprints and/or copyright permission, please contact The YGS Group, 1808 Colonial Village Lane, Lancaster, PA;

(717) 399-1900 ext. 125, or via email to Ashley.Zander@theYGSgroup.com.