By Douglas DaSilva, Research Program Manager, University of Wisconsin - Madison Institute for Clinical and Translational Research

Douglas DaSilva participated in the June 2009 Biospecimen Management Workshop in Madison, Wisconsin, which is an activity of the Biospecimen Management Collaborative Intitiative hosted by PercipEnz. During the workshop, Mr. DaSilva gave a presentation about the COAST project. This article is based on that presentation.

To better understand the concept of atopic diseases (including asthma and allergies), one must consider how the immune system develops over time. Various scientific research studies have elaborated on the concept of immune system dysfunctions, which can be present at birth and/or developmentally regulated over time. These immune dysfunctions have been considered to be important markers in determining a person’s response to viral infections. To address such hypothesis, Dr. Robert Lemanske Jr. from the University of Wisconsin – Madison, designed the Childhood Origins of Asthma Project (COAST), a prospective study evaluating the interactions among age, patterns of cytokine secretion, and viral infections with respect to the subsequent development of asthma and allergic diseases.

A Breadth of Perspectives to be Represented in this Onsemble Event

A power-packed roundtable discussion has been assembled to explore issues around patient accrual as part of a pre-conference workshop at the upcoming Onsemble 2009 Fall Conference. For the fifth consecutive conference, a workshop will be included that is specifically designed for clinical trials office leadership. As in the past, this workshop will also focus on developing measurements, or “metrics,” for the purposes of understanding and improving clinical research operations.

A breadth of perspectives will be represented by two special guests who have been invited to give presentations and participate in the patient accrual roundtable.

An Integrated Approach to Evaluating & Selecting an Informatics System for the Clinical Research Enterprise

For large research institutions, deriving real value from investments in research informatics requires long-term vision and carefully honed selection criteria. The evaluation and selection process can be enhanced by utilizing a technique known as the Whole Product approach.

Clinical Trial Metrics: Protocol Performance and Resource Utilization From 14 Cancer Centers

The project to which over half of the OnCore cancer centers contributed data was selected for presentation at the ASCO Annual meeting in Orlando this May. For those who were not able to attend the conference, the poster and e-poster presentation are available for download at:

http://www.crescendoex.com/pb.php

Authors are Henry Durivage, PharmD, Director of Human Research Services, The Cancer Institute of New Jersey, and Director, CINJ Oncology Group and Kerry Bridges, MBA, BSN, CCRC, Administrator, Clinical Research Office, Indiana University Simon Cancer Center.

Well-Organized Implementation Delivers Results in Under Five Months

Following a rigorous and well-organized implementation plan, the Chao Family Comprehensive Cancer Center (CFCCC) of the Unversity of California-Irvine has begun using OnCore just five months after kicking-off the project.

"We have to commend the leadership team at the Chao Family Comprehensive Cancer Center," said Srini Kalluri, president and CEO of PercipEnz. "They acquired the necessary resources and assembled a focused, motivated team to carry out the implementation on their end."

"Overall the transition has been positive. For years our staff have been looking forward to having a enterprise-level system like OnCore to assist their clinical research workflow," said Jacqueline Orozco, Assistant Director for Finance and Operations at CFCCC. Orozco notes, however, that for a few independent research groups who conduct their own trials outside of the Clinical Research Office, using the new system might be perceived as a duplication of effort. "Our goal is to help the independent research groups understand the benefit that even a limited use of the new CTMS would offer their research team; i.e. comprehensive data management and reporting, study performance review, protocol management, etc."

PercipEnz Training Program Expands Video Selection and Reaches More Users

Corresponding with the release of OnCore Version 9.0 this spring, the training videos provided as part of the PercipEnz Training Program were expanded to include videos for an additional functional area of OnCore.

Since September 2008, there have been training videos for Subject Management and Protocol Management available on www.Onsemble.net. Totaling almost 60 videos, these have all been updated to reflect changes in OnCore 9.0. Six new videos were added to existing functional areas and a further six new videos were introduced for the new Protocol Calendar & eCRFs area.

Goal to Develop Collaborative Partnerships was Key Factor in Decision

An institutional goal to develop collaborative partnerships with other research organizations was a key factor in the recent decision by the University of Florida Shands Cancer Center (UFSCC) to select OnCore products in support of their clinical and translational research informatics needs. With the signing of the contract, the UFSCC has become the 25th cancer center to adopt the OnCore platform in support of their clinical research informatics needs.

"We began looking for a new clinical trials management system primarily because of our collaborative agreement with the Moffitt Cancer Center," said Giselle Moore-Higgs, Assistant Director of Clinical Trials at UFSCC. "We wanted a system that would allow us to do collaborative clinical research and share data with other organizations and OnCore allows us to do that."

We return to the Monona Terrace
Community & Convention Center
for the Onsemble 2009 Fall Conference

Monona Terrace
Madison, Wisconsin
September 2nd - 4th

Make Your Lodging
Reservations Today!

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