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Managing
Clinical Trial
Management is the most critical business
process in a Life Sciences firm. Clinical
trial progress is the final step to
Regulatory Approval and must be monitored
and optimized to assure maximum prescribing
life for a company's multi-million dollar
product investment. We are Clinical
Operations Efficiency Specialists dealing
with firms who see trial efficiency as a
core competency.
3C brings years of
experience working in and serving the
Pharmaceutical Clinical Business area to
each and every engagement.
Our teams include experienced mangers who
have worked in the industry in line
functions from CRA to Director level, and
who speak the language of Clinical Trials
fluently. These abilities allow us to
make immediate progress moving your
operations forward with a blend of
technology and business process adjustment
solutions.
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Clinical Trial
Management Systems (CTMS)
A Large Global
Pharmaceutical had outgrown its Trial Management
system
and
after an extensive search decided to custom
develop the tool.
The project was outsourced to a large and
well-recognized consulting firm for design and
development. After expenditures totaling several
million dollars, it was clear that the vendor
did not understand the clinical business and
would not be delivering a successful product.
The firm disengaged the vendor and brought the
project in-house. Peter Oudheusden, founder and
current President of 3C Company, re-designed key
areas of the application to better meet the user
expectations and deliver a tool that was a tight
fit to the needs of the ever-growing,
ever-changing trial management process.
Years later, the Trial Management System has
become the hub of Clinical Operations -
accepting external feeds from labs and EDC,
interfacing with a data repository for
reporting, and feeding the grant management
system to generate site payments. 3C staff
continue to play critical roles in its continued
evolution with Business Analysts, Developers,
Validation Specialists and Technical Support
staff. The 3C contribution continues stronger
than ever, reaffirming the company’s commitment
to the success of its clients and the hundreds
of system users around the globe. We are not
done with a project until the client is
experiencing the benefits they initially set out
to attain. |
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Study Planning
Global Clinical trials are conducted regularly
by this large pharmaceutical company,
and the efforts need to be coordinated among
dozens of subsidiary corporations around the
world. Additionally, different departments
within the company have steps they need to
perform in the various stages of the study, from
Medical Writing to Clinical Operations and from
e-Clinical to Clinical Data Management, and the
traditional “hallway conversations” had outlived
their usefulness in this regard.
Use
of the planning features within the
organization’s CTMS had grown to a
point where study planning involved hundreds of
tasks, making it complex and unwieldy for
practical use. 3C Company was engaged to
rewrite the planning tool, providing project
plan views based on the user’s role within the
organization. Additionally the capability was
added to update multiple plans simultaneously,
using a spreadsheet-like interface to update
similar tasks for all the sites in a study. As a
result, Study Monitors are keeping their plans
more current with less effort, and Clinical
Operations is effectively coordinating across
departments without reliance on the infamous
“hallway conversations”. |
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3C has experience in all
facets of Clinical Operations and Trial
Management Effectiveness. Contact us
to find out more about our work in the area of:
-
Trial Progress Tracking: Study Start Up,
Conduct, and Closeout
-
Inter-departmental and Global Trial
Execution Coordination
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