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Eliminate delays, reduce errors, and increase data quality

The key to an efficient data management setup is to design a rigorous data management plan.

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  • How to design the data management plan for your study
  • What to consider before setting up a study for Electronic Data Capture
  • How to increase the efficiency in testing and planning

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The EU MDR- Driving a safer healthcare ecosystem

With continuous advancements in technology, more medical devices are being developed. Though new and innovative devices can transform healthcare, there’s a growing need to regulate the MedTech industry - not only to protect the patients but to leverage its full potential.

Here are some of the more notable changes in the EU MDR

  • Wider and clearer scope for EU legislation e.g. include implants for aesthetic purposes

  • Stronger supervision of assessment bodies by national authorities

More power to assessment bodies to ensure regular checks on manufacturers and unannounced factory inspections 

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Optimising clinical evaluation for medical devices 
Improve the process, not just the tools

This white paper includes three key actions on how the process of clinical evaluation can be optimised by providing the answer to the questions below.

  • Why is it important to digitise the data collection for a clinical investigation?
  •  How can we improve protocol design?
  • How can you achieve higher quality evidence?

Consequently, from asking the right questions the benefits become evident.

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Design better forms, save time and lower costs

With better designed forms, we’ve seen increased compliance rates, better data quality, and better communication between study participants.

This has lead to decreased time spent on data management, which results in lowered costs, and eventually shorter time to market.     

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  • The 7 principles of an optimal eCRF design process.
  • How to speed up your eCRF design process
  • How to acquire more quantifiable data

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