What's New in Clinical Trials at Westat

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12/30/2008

New Oracle® Clinical Remote Data Capture Application

Westat has implemented the latest version of Oracle Clinical's Remote Data Capture (RDC) Onsite 4.5.3 HTML. This version of the RDC application offers a number of improvements over earlier versions, making it very user-friendly while maintaining the ability for the site to enter data in a confidential environment. Here are a number of other reasons for using this new version:

  • "Zero footprint," which means no specialized software necessary.
  • Accessible via a web browser and standard Internet connection.
  • Accessible by entering user name and password because database information is no longer required
  • Drop-down menus for easier searches.
  • Rapid navigation to case report forms (CRFs) via sortable, searchable list of patients.
  • Cleaner, more logical interface.
  • Multiple page viewing, up to three screens at one time.
  • HTML forms similar to eCRFs.
  • Individual or batch approvals and verifications of eCRFs.
  • Improved Patient Data Report—single PDF file of all CRFs entered per patient; certified copy of data at study conclusion for electronic submissions.

For more information:
Contact Westat

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10/10/2008

Nancy L. Dianis to Participate in Conference on Clinical Outsourcing

Nancy L. Dianis, Vice President and Associate Director of Westat's Clinical Trials Area, will participate in a panel discussion at the Fundamentals of Clinical Outsourcing Conference. The conference, which is sponsored by the Institute for International Research [*], will take place in the following cities:

The panel discussion that Ms. Dianis will participate in, Relationship Management: The Rules of Engagement, is scheduled for the second day of each conference at 1:30 p.m.

The panel, which also includes representatives from pharmaceutical companies, will discuss a number of topics:

  • Selling yourself as a client
  • Motivating performance of joint clinical study teams
  • Evaluating performance, teams, and expectations
  • Optimizing communication across all vendors and the sponsor's clinical team members
  • Drafting and implementing an issue escalation plan

This 2-day program combines case studies, lessons learned, sponsor- and contract research organization-led interactive panels, and breakout roundtable discussions.

Other topics that speakers will address include the following:

  • Mapping the clinical development outsourcing process
  • Understanding the different outsourcing models
  • Creating a corporate outsourcing strategy
  • Detailing external service provider identification, assessment, and selection
  • Adhering to timelines and other measures of success
  • Managing effective project closure

For more information:
Contact the Institute for International Research [*]
1-646-895-7432
mrand@iirusa.com

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09/09/2008

Dr. James J. Korelitz to Discuss the Role of Secondary Data at Clinical Conference

Westat's Dr. James J. Korelitz, Associate Director and senior epidemiologist, will speak at the 11th Registries and Post-Approval Studies Congress [*]: Design Post-Approval Studies for Improved Safety and Risk Assessment While Meeting Clinical, Safety, Marketing, and Regulatory Objectives. The conference is being held September 23-25, 2008, in Washington, DC.

On Thursday September 25th, Dr. Korelitz will speak on the role of secondary data as a source for post-approval studies.

All clinical trials, most registries, and many post-approval studies rely on primary data-data collected from patients and/or clinical staff directly by investigators for a specific study. Other data sources, known as secondary data, can also be used to conduct post-approval studies. Although these data are not collected for the expressed purpose of a post-approval study, in many cases they can still be used to simulate a typical observational study. Proper analyses of these data can provide important information about the safety and effectiveness of therapeutics and devices. Dr. Korelitz will discuss the advantages, limitations, and potential pitfalls of using secondary data for post-approval studies.

Other topics that speakers will address include the following:

  • Current climate and new policies and standards surrounding post-approval studies,
  • Effective design and development of successful post-approval studies,
  • Risk management and safety surveillance, and
  • Evaluation and measurement of post-approval studies.

For more information or to register: https://www.cbinet.com/show_conference.cfm?confCode=PC08055 [*]

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08/19/2008

Westat's New Philadelphia Office Focuses on Pediatric Research

Westat's Health Sector has entered into an agreement with the Children's Hospital of Philadelphia (CHOP) to operate the CHOP-Westat Biostatistics and Data Management Core (BDMC). The BDMC supports investigators from virtually all subspecialties of pediatric medicine and is currently involved with more than 70 studies, ranging from narrowly defined basic science projects to very large, multisite clinical trials.

Westat is excited about the opportunity to join forces with this premier research institution, and we are confident that our strong reputation in health research, coupled with the abilities of the BDMC staff, will advance these research efforts.

Twenty-three professionals already working at the BDMC have become Westat employees, as part of Vice President Steve Durako's study area. The BDMC staff includes biostatisticians, clinical data analysts, data managers, and others. The Philadelphia-based staff will be augmented by management, technical, and support staff from our Rockville, Houston, and North Carolina offices.

Westat welcomes these new staff members located on the CHOP campus in Philadelphia.

For more information:
Contact Westat

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07/11/2008

Westat Staff to Participate in AIDS 2008 Conference

Westat researchers will be making a variety of presentations at the XVII International AIDS Conference [*] (AIDS 2008) in Mexico City, August 3-8, 2008. The theme of this year's conference is Universal Action Now. Westat staff (names in bold) will be contributing as follows:

Karen M. Megazzini, Namwinga Chintu, Sten H. Vermund, David T. Redden, Daniel W. Krebs, Maureen Simwenda, Bushimbwa Tambatamba, Moses Sinkala, and Jeffrey S.A. Stringer. (Poster.) Predictors of Rapid HIV Testing Acceptance and Successful Nevirapine Administration in Zambian Labor Wards. (Completed by the Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.)

Karen M. Megazzini, Moses Sinkala, Sten H. Vermund, David T. Redden, Daniel W. Krebs, Edward P. Acosta, Joyse Mwanza, Robert L. Goldenberg, Namwinga Chintu, and Jeffrey S.A. Stringer. (Presentation.) A Cluster-Randomized Trial of Enhanced Labor Ward-Based PMTCT Services to Increase Population Nevirapine Coverage in Lusaka, Zambia. (Completed by the Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.)

Moussa Sarr, Birahim P. Ndiaye, Hugues Loemba, and Mwenda Yasa. Overall and Diarrhea- or Lower Respiratory Infections-Related Mortality Among Formula-Fed and Breast-Fed Children of HIV1-Infected Women in Africa: A Meta-Analysis.

Be sure to check the full program of events [*] for more specific information on the various presentations and sessions that will be held during this conference.

For more information:
Contact Westat

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