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MaxisIT - Clinical Portfolio Management

Leveraging abundance of information available from internal and external


sources, the industry needs a transformational strategy by making a move
from a retrospective modus operandi to a more predictable and proactive
action oriented clinical research and development model; wherein key
stakeholders can proactively plan and act in time rather than analyzing the
outdated information on what happened in the past.
Knowing the unknowns is important for an accurate and informed decision to
be made , be it in a timely manner with an optimal use of resources will help
to maintain integrity of decisions and balance the desired benefits.
Industry has either looked into this aspect or started to adopt manual
solutions or has just realized the need for one unified solution.
Some of the evolving business scenarios center around either the planning,
operational, or clinical activities but not one is integrated. Operations
performance indicators including but not limited to study start-up,
enrollment, data acquisition rate, site close-out, etc are large variables on
the competence of the executing CRO/s and provide primitive information
based on hybrid approaches. Quality management and regulatory
information management are equally vulnerable. Areas that get the most
attention are the clinical performance indicators where there is maximum
levy due to its key performance indicators, being safety and efficacy. Industry
is quickly transitioning from traditional conduct of clinical trials to more
agile and adaptive designs. Learning the effects of study design early in the
trial phases and identifying what works and what doesn't can save huge time
and costs as well as allow sponsors to conduct trials with minimum patients
using the dosage that will work. So there are enough motivations to pursue
the adaptive designs but industry still remains at the stage of not having the
right infrastructure that can support such information management and the
decision-making process in an integrated fashion. Find more information..
http://www.maxisit.com/

203 Main Street, Metuchen, NJ 08840


URL: http://www.maxisit.com

Phone: 1-877-(629-4748)
Email: info@maxisit.com

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