
PHARMAMATICS dictionary management/coding solutions and services
are backed by an insight from over one and half decade supporting
hundreds of phase I – phase IV clinical trials and large
pharmacovigilence databases for global bio-pharmaceutical, device/CRO
majors. They are designed to allow small organizations implement
and utilize mature dictionary management and coding practices easily
and large organizations to optimize and benefit from the significant
efficiencies our systems and services offer.
Medical dictionaries (MedDRA, WHODRUG or legacy) and how they
are used affects several important activities at the very core
of a bio-sciences organization's fundamental goal: to bring innovative
therapeutics to the market cost effectively and keeping them there.
The chief strengths (large size, high granularity and constant
maintenance) of standards such as the MedDRA dictionary can help
enhance the quality and reliability of critical functions such
as accurate capture and exchange of safety information, aggregation
of reported terms, identification of common data sets, consistent
case retrieval and generation/evaluation of safety signals. But
these strengths are double edged as the same factors can also encumber
effective dictionary management and coding practices that are foundational
for all the above activity. If the additional costs of size and
complexity are not adequately mitigated through planning and practice
backed by knowledge and skill the full benefits of switching to
standards such as MedDRA may not be realized.
In fact, implementing a truly effective dictionary management
and coding practice has to be based on an organization’s
historic practices, state of implementation and utilization of
various activities, knowledge of the emerging context and changes
in it and an ability to bridge cross-functional needs with cross-functional
expertise - ensuring, always, that scarce resources are optimally
utilized.
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