Statement
of Capabilities
Respiratory Research, Inc, and Cenetron Diagnostics
are pleased to offer comprehensive laboratory services for
EBC sample analysis utilizing the unique transportability of
the RTube Exhaled Breath Condensate Collector. This service
is offered through a central laboratory in Austin, Texas that
operates worldwide and has been supporting clinical trials,
pre-clinical drug development and individual physicians since
1995. Only Respiratory Research, Inc., in partnership with
Cenetron Diagnostics, provides the complete Exhaled Breath
Condensate solution for collecting samples in almost any setting
providing centralized laboratory analysis as a turnkey service.
Experience
- Participation in seven large clinical trials with pharmaceutical
and biotechnology companies
- Staff experienced in new test development and validation
- Management team with diverse experience and proven track
record
Clinical Trial Services
- Provide clinical trial start-up services
- Provide sample collection logistics
- Provide sample storage
Project and Data Management
- Integrated Laboratory Information System that is 21 CFR
part 11 compliant
- Dedicated project manager
- Custom-designed reports and web-based data reporting
Quality Assurance and Licensure
- Experienced Quality Assurance Manager
- Secure, state of the art laboratories that meet or exceeds
applicable GCP requirements and standard good laboratory
practices
- Licensed and accredited by CLIA, CAP, and key state agencies
Key Personnel
- Dwight DuBois, MD
Dr. DuBois is the President and Medical Director of Cenetron
Diagnostics. Dr. DuBois received his medical degree from
the University of Texas, followed by training in Internal
Medicine at Case Western Reserve University, and completion
of a NIH fellowship in Infectious Diseases at the University
of Washington. He founded Cenetron Diagnostics in 1996,
and is widely recognized as an authority in the field of
molecular diagnostics. Dr. DuBois is the principle inventor
of Armored RNA, a key technology in the development of
quantitative molecular assays for RNA targets, such as
Hepatitis C Virus and Human Immunodeficiency Virus. Dr.
DuBois is the author of scientific publications, book chapters,
and numerous patents in the area of molecular Diagnostics.
- Chris Heidel
Chris Heidel joined Cenetron Diagnostics as the Quality Assurance
Manager in June 2003. Ms. Heidel holds the nationally recognized
Registered Quality Assurance Professional in Good Laboratory
Practices (RQAP-GLP) certification through the Society
of Quality Assurance. Prior to coming to Cenetron, Ms.
Heidel was with Cedra Corporation in Austin, Texas for
seven years. At Cedra, Ms. Heidel gained experience in
GLP pharmaceutical laboratory research, including almost
four years in Cedra's Quality Assurance Unit where she
was Quality Assurance Manager. Ms. Heidel administers regulatory
compliance and directs quality assurance throughout the
organization through staff training, internal audits and
inspections, standard operating procedure review, and external
audit management. In addition, Ms. Heidel serves as an
internal consultant to Management, providing troubleshooting
advice for policy management and incident corrective action.
|
