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From Excel To EDC - Nobel Biocare Case Study

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4 views2 pages

From Excel To EDC - Nobel Biocare Case Study

Uploaded by

Ayman Ali
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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The Switch from Excel to EDC Software

A Case Study
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Dental implant manufacturer, Nobel Biocare, continuously strives to deliver state-of-the-art


implant-based dental restorations to professionals to ensure better quality of life for patients around
the world.

Nobel Biocare manages clinical activities internally, and with the demands of the EU MDR the need
for post-market studies is significantly increasing. Therefore, Nobel Biocare must run both
prospective and retrospective studies to ensure MDR compliance.

Challenge
In the past, simple clinical studies like these were conducted in Excel sheet templates, which was
extremely time consuming. Data management required a lot of work and the process would not
have been regulatory compliant with the implementation of EU MDR.

For the upcoming trials, Nobel Biocare needed to ensure:

● A simple yet 100% technical and regulatory proof system


● Easy study setup
● Flexible export options
● All data is in one place
● State-of-the-art data security
● Complete traceability

Solution
Nobel Biocare selected SMART-TRIAL by Greenlight Guru’s EDC software and SMART-TRIAL Cases
as the solutions. This enabled all needed types of post-market studies in a single system with
complete data traceability and security.

© 2023 Greenlight Guru | MedTech Lifecycle Excellence (MLE) Platform


Additionally, SMART-TRIAL by Greenlight Guru’s eCRF solution allows duplication of study setups,
which made it easy for Nobel Biocare to copy-paste study setups from product to product.

Results
Replacing Excel spreadsheets with the SMART-TRIAL by Greenlight Guru facilitated Nobel Biocare’s

challenges regarding data collection and management. Compared to the former solution, the three
main improvements were:

● Vast reduction in time spent on data management and study setup


● Less worrying about data security
● Simplified collection of MDR compliant post-market data

‘’We really needed an EDC with easy setup and fast buildup where everything can be
done by yourself. That’s exactly what we got with the SMART-TRIAL platform. It
helped us simplify our processes so much – especially because of the ability to
duplicate study setups. It’s a very cost-effective solution and it helped us save a lot
of internal resources.’’

Florian Kübler
Senior Clinical Research Associate, Nobel Biocare

© 2023 Greenlight Guru | MedTech Lifecycle Excellence (MLE) Platform

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