Founded
in 1998, Auxesia,
a division of The Visual Consultancy Corporation, works closely with
top-notch contract research centers in Europe and North America, providing
a full range of non-clinical research services, including animal toxicology,
metabolism and analytical testing; (pre-) clinical services, ranging
from protocol design to statistical analysis, bioanalytical services,
drug safety testing procedures, comprehensive reporting and full clinical
program management from data review and study design to initiation,
but also monitoring of compliance protocols, trial monitoring, QA-audits,
report writing, regulatory affairs, data management and consulting.
Together with 9 associate partners in 12 countries around the globe,
Auxesia manages
and coordinates early (Phase I) clinical testing in healthy volunteers
to Phase II and Phase III studies in patients for pharmaceutical companies
worldwide.
Auxesia's clinical research staff manages
studies in patient populations at individually selected hospitals
and health centers, covering a variety of the most important therapeutic
categories, including Oncology/Hematology, Immunology, Cardiovascular,
CNS, Dermatology, Endocrinology and Gastrointestinal.
Auxesia highly trained staff is experienced
in comprehensive contract trial development and execution, but can
also assist with a companies own clinical studies. Whatever the requirement,
Auxesia success
is based on an ability to work with clients in partnership, tailoring
its services to fit client's exact needs at every stage.
Sandstone Health Research Partners, Auxesia
global network of international healthcare research partners,
enables us to handle part of a project or do it all on a turnkey basis.
From pre-clinical to Phase IV, Auxesia helps provide
the vision, the execution and the follow-through that guarantees success.
Auxesia provides
expert planning and management of multi-national clinical trials,
and preparation of study materials.
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Our staff is experienced in
clinical trial design, study management, monitoring, and statistical
analysis for both pre- and post-market studies of medical devices
and diagnostic products. We strive to maximize cost-effectiveness
and efficiency for our clients while maintaining consistent standards
of the highest quality in all our clinical services.
Auxesia is
a proud member of Sandstone Health Research Partners, a global network
of research agencies with 9 corporate members in 12 countries around
the world. Together with our partners at Sandstone Health Research
Partners, we offer a full range of clinical services including:
Summary of Clinical Research Services
Auxesia provides expert planning
and management of multi-national clinical trials, and preparation
of study materials. Our staff is experienced in clinical trial design,
study management, monitoring, and statistical analysis for both
pre- and post-market studies of medical devices and diagnostic products.
We strive to maximize cost-effectiveness and efficiency for our
clients while maintaining consistent standards of the highest quality
in all our clinical services.
Preparing
Study Materials
|
Literature reviews |
Clinical protocols development |
Case Report Forms (CRFs) design |
IRB/Ethics Committee submission materials |
Study handbooks and investigator agreements |
Managing
and Monitoring Trials
|
Project Management |
Site/investigator identification |
Site/investigator qualification and selection |
Liaison with IRB's/Ethics Committee's |
Liaison with regulatory bodies |
IRB/Ethics Committee submission materials |
IRB/Ethics Committee consent documents |
Organization of Investigator Meetings |
Site personnel Training |
Compliance via site monitoring/auditing |
Auditing for FDA, GCP & EN540 conformance |
Adverse Event reporting |
Providing
Data Management
and Statistical Analysis
|
Issue Randomization codes |
Database and data entry screen design |
Data validation |
Data QC, coding, entry, and verification |
Statistical analyses & clinical report preparation |
For additional information,
please contact
Andrea Hedges in our Paris office.
For
more information Contact
The Visual Consultancy Corporation
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