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Data Management
CCSA Data Management (CCSADM) is dedicated to delivering the
highest-quality, lowest-cost data management solutions to the
biopharmaceutical industry. We provide complete solutions for
preclinical, clinical, and safety data management needs, using
the industry's leading technologies to define, collect, clean,
report, extract, and archive data from protocol review through
to database closure.
Our effective procedures speed investigational drugs and devices
on their way to regulatory approval. Our experienced data management
team reviews finalized protocols and uses Oracle's web-based CDMS
to develop the study structure, eCRFs, and data cleaning programs.
Once the study has been tested, we distribute the eCRFs to sites
and begin collecting, cleaning, and reporting on the clinical data.
Using web-based systems to design, manage, and report on studies
allows CCSADM to provide the customer with an inexpensive interface
to both clinical and study metrics data. In addition, web-related
technologies such as XML allow CCSA to share data among our databases
without wasting resources, and thereby reduces overall cost for our
clients.
Strategic partnerships give us exclusive access to new commercial
off-the-shelf software designed for use with our industry standard CDMS.
Through our partnership with a secure site provider, CCSA communicates
through the World Wide Web while remaining in compliance with all
regulatory requirements under 21 CFR Part 11 and HIPPA.
Validation and site audit materials are available upon request.
Industry and company standards to which we adhere:
Software
- Oracle Clinical (OCL)
- Oracle's Thesaurus Management System (TMS)
- Oracle's Remote Data Capture (RDC)
- Adobe Acrobat
- IE 5.5
- Netscape Navigator 4.7
Hardware
- SUN Enterprise Level Systems
- Dell Enterprise Level Systems
Databases
- Oracle 8.1.7 RDBMS (for OCL v4.0)
- Oracle 9i RDBMS (for web-based reporting)
OS
- SUN Solaris 2.8
- Windows NT 4.0 SP 5
Protocols/Languages
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