The challenges and needs of RWE medical device studies

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www.makrocare.com
THE CHALLENGES AND NEEDS OF RWE MEDICAL DEVICE
STUDIES
Real World Evidence
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REAL WORLD EVIDENCE STUDIES
Regulatory agencies and health care providers
around the world are requiring additional data
about the long-term safety and effectiveness of
new medical device when they are used by larger
patient populations in the real world setting.
The challenges and needs of RWE medical device
studies like post marketing follow up, QoL
studies are different than the pre-market
authorization studies in terms of strategies,
designs and executions. MakroCare understands
strategic, operational as well as technology
needs of RWE device studies and therefore offers
customized centralized, high quality solution to
design and execute these studies more cost
effectively.
M E D I C A L D E V I C E S - R W E
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Centralized solution for device RWE studies
MakroCares centralized solution for device RWE
studies brings cost saving up to 30-40 by
optimizing processes, integrating customized
technology and using central coordinating teams.
M E D I C A L D E V I C E S - R W E
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How we can win
Highly experienced clinical experts to support
study design Processes for quick start-up,
monitoring close out Smart Technology for
bringing cost - efficiencies Expert Central
Monitoring / Coordinating Team
M E D I C A L D E V I C E S - R W E
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