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Cloud-Powered Solution: How Askel Healthcare Transformed Regulatory Imaging Studies with Collective Minds

Askel healthcare - Collective Minds

Industry

MedTech

Challenge

Askel Healthcare needed a cloud-based solution for a regulated reader study including medical imaging.

Results

Collective Minds platform facilitated image data collection from multiple centres as well as image assessment and result delivery in a traceable and compliant manner. The cloud-based solution enabled Askel Healthcare to manage the project in an effective way, while at the same time ensuring data integrity and security.

Key Product

Research

Askel-healthcare

Askel Healthcare

Askel Healthcare is a Finnish medical technology company set to transform surgical knee cartilage treatment and recovery. Their mission is to keep people in motion through their universal COPLA® implant, which is a ground-breaking innovation for the repair of knee cartilage defects.

The Regulatory and Multicenter Imaging Challenge

Askel Healthcare needed a cloud-based solution for a regulated reader study with medical imaging endpoints. Image data was to be collected from multiple centres in several countries, and the image assessment was to be done by multiple reviewers based in different countries. Data management needed to be handled securely and compliantly  while facilitating data sharing and access for the different project members. 

From Data Transfer to Diagnosis: The End-to-End Research Solution

Collective Minds Radiology offered their Research workspace, handling all aspects of study management and execution. This included secure data transfer via Proxy or web upload, quality control, reading events for various classifications, and providing a reviewer from their MSK radiology community. The solution also ensured compliance with medical device and data privacy regulations (ISO-134085, GAMP5, MDR Class IIb, ISO 270001, GDPR).

Pilot Study Success: Efficient, Compliant, and Scalable

 The pilot study included reader study design, image transfer and review modules, setup, data transfer and storage. The access control through roles and permissions in combination with full traceability facilitated project execution in a compliant and effective manner, saving time and resources for Askel Healthcare while at the same time ensuring compliance and data security.