For Immediate Release

e-CRO ResearchPoint Expands Services

AUSTIN, Texas - Jan. 13, 2004 — ResearchPoint, an e-CRO, recently expanded its data services with the addition of Darlene Gaddy, Director, Clinical Data Services. Gaddy brings over 10 years of clinical trial experience with eight years in the field of Clinical Data Management.

Prior to joining ResearchPoint, she was Associate Director, Clinical Data Management for PPD Development, Inc. In this position, she was responsible for the execution of Clinical Data Management activities for Phase II-IV clinical trials. Gaddy also served as a Global Project Manager for large Phase III and IV stand-alone studies that included extensive experience within the anti-infective, cardiovascular, CNS, and oncology therapeutic areas.

"We believe Darlene is the right person to lead our expansion efforts," said Carol Breslauer, Vice President, Operations, ResearchPoint. "She has embraced our company's model, which combines the roles of the traditional field CRA with the in-house data review work traditionally performed by a data coordinator. We refer to the model as Data Quality Monitoring or DQM."

Gaddy's initial charge is to integrate traditional data management practices into the DQM model and to establish an infrastructure required to accommodate ResearchPoint's current backlog and position itself for planned growth. ResearchPoint's data management division is expected to more than double in size within the first quarter 2004.

ResearchPoint takes a different approach to resourcing its team members. A core team of database experts perform the initial database creation and edit check programming using ClinPlus, a 21 CFR Part 11-compliant, fully validated SAS-based clinical data management system developed by DZS Software. The DQM team is then trained on edit checks and begins to monitor in the field and perform data cleaning and review functions in-house. This results in less travel and more accountability and ownership of the data for the DQMs. "We have enjoyed great success with this model," said John Farinacci, President and CEO of ResearchPoint. "The results for our customers are fewer queries, due to the fact that the people in the field are more intimately involved with the data, and a faster response on those data queries that are generated. The net result is a faster database lock, even with paper-based studies. This model has also provided the additional benefit of expanding the scope of learning and responsibility for our staff." As a result of this and the increasing volume of contract awards, the company has taken additional office space at its corporate headquarters in Austin, Texas.

"Our management team has over 75 years of combined experience in the pharmaceutical and CRO industries so we have had the opportunity to learn from the best and worst experiences. This model is one that breaks down the barrier that has traditionally existed between the clinical monitor and the data manager. By doing this, we can offer our clients cleaner data faster," Breslauer said.

ResearchPoint is an e-CRO which combines traditional and electronically-enhanced services to the pharmaceutical biomedical and medical device industry. ResarchPoint technology initiatives have focused on communication and training, as aids to accelerate trials by improving quality.

For more company information, please contact Stacey Labatut, ResearchPoint, 512-343-1092 or slabatut@researchpoint.com, http://www.researchpoint.com.

 

 

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