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In today’s competitive environment, Clinical
Operations is more than a matter of
coordinating research activities - It is an
opportunity to gain significant strategic
advantage by leveraging process and technology
improvements across the organization. For years
3C Company has been helping leaders in the
pharmaceutical industry identify and implement
these changes.
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EDC Implementations
For decades the monumental
efforts of collecting & cleaning study data have
challenged Clinical data management teams
to apply the very best technologies to get drugs
to market sooner. Collecting the data
electronically has long been a goal, and today’s
web technologies have made this much more
attainable. But to the unwary Clinical team, the
challenges of programming EDC forms, validating
databases and training investigator staff can lead
to surprising delays in beginning enrollment. 3C Company can help your team properly leverage
these technologies for improved results. |
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Study Portals
Portals are terrific for
delivering information to people with a shared
interest, and 3C Company has found
this technology to be extremely effective when
applied in the context of a Clinical study. Team
members can quickly reference the Protocol and
amendments; share sample flowsheets with
Clinicians; communicate SAEs; provide payment
status to investigators; and even deliver
presentations and education via streaming media. |
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Electronic Submissions
Most of the world’s
Pharma’s develop their submission materials
electronically, and in an earnest
effort to streamline the approval processes the
FDA has prepared for electronic submission. 3C can
help your organization leverage this technology
for strategic advantage, before it’s too late. |
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e-Signature
The FDA provides strict
guidance when it comes to electronic approval
processes, but for 3C e-signatures are
more than a compliance issue. This technology can
streamline your entire Clinical operation, basing
processes on electronic workflow and discarding
the shackles of paper documents. |
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E2B Electronic Transmittal of Medwatch Reports
Electronic transmittal of
safety data is replacing traditional printed
Medwatch reports. If you have not yet
made this transition, 3C Company can guide you
there. If you have implemented and are not getting
all the benefits you hoped for, our professionals
can help re-engineer your processes to maximize
return on this technology investment.
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Integrating Clinical Systems
In the dynamic environment
created by advancing technology and Clinical
applications, the spector of Information Overload
looms large. If all these systems do
not communicate with one another, the Clinical
team can quickly find itself entering the same
date two, three or more times; disputing reports
with conflicting data; and focusing on systems
challenges rather than Clinical Research. Find out
how 3C Company helped this large pharma
integrate its Clinical systems and avoid this
nightmare.
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