|
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.
|