Centralized Solution for Medical Device 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.

Learn more about how MakroCare’s centralized solution for device RWE studies brings cost saving up to 30-40% by optimizing processes, integrating customized technology and using central coordinating teams.

RWE post marketing studies

Highly experienced clinical experts to support study design:

  • Expert consultation for customisation of study design to optimise the outcomes related to medical device effectiveness and safety
  • Insightful study design considering real world use of the device and anticipating physicians and patient needs
  • Effective study design to minimise burden on the sites and optimise patient engagement & compliance

Processes for quick start-up, monitoring & close out:

  • Based on the need of RWE device studies, MakroCare offers customised centralised processes integrated with technology for site selection, activation, monitoring data collection, site performance management & safety monitoring
  • Routine site management and monitoring activities managed seamlessly centrally/remotely using standardised and efficient processes keeping on-site activities almost null and yet ensuring quality

Smart Technology for bringing cost- efficiencies

  • Customized technology to support key processes, bring transparencies , improve data collection and monitor study progress
  • Data driven, analytical approach to facilitate right amount of monitoring, improve oversight, accountability and support risk management proactively
  • Helps in managing most of the study activities centrally/remotely bringing down study cost significantly and also minimizes time consuming processes such as document collection/distribution etc lowering the administrative cost further
  • Scalable & flexible proprietary technology approach to accommodate protocol & regulatory requirements

Expert Central Monitoring / Coordinating Team

  • Right, experienced resource pool like PM, central/remote monitor, medical monitor etc. and to support sites as the point of contact
  • Experienced PM and central monitoring team using risk based monitoring approach ensure quality, timelines and better monitoring of patient safety

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