How to Design an

Electronic Case Report Form

The 7 Priniciples behind a good eCRF 

For the past couple of years, we have helped many organisations in both setting up and designing forms for electronic data capture. This covers everything from multi-site trials to post market surveillance and public research.

This paper gathers both our experience and knowledge from these various projects. It outlines and exemplifies the most important elements of designing a solid eCRF.

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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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.

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

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

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Navigating the EU MDR -

Strategies for Success

 

The New 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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