The collaboration of Peili Vision and Labquality started in 2021 with defining and documenting the purpose of the ARVO service for healthcare. Labquality has also set up a quality management system (QMS) for Peili Vision using Scilife as the platform. The collaboration continued with the certification of medical device capability following the EU Medical Device Regulation (MDR).
The game-like EFSim Test software helps identify ADHD-related challenges
Peili Vision chose Labquality as the partner for a clinical study to assess the performance and safety of their browser-based, game-like medical software (see screenshot of it). The solution, named EFSim Test, is intended for easier, faster assessment of challenges in executive function associated with activity and attention deficit disorder (ADHD) for children aged 8-13 years.
"EFSim Test simulates everyday life and the home environment. It gives the child stimuli and stresses their cognition in situations without clear instructions. This can reveal, for example, potential impulsivity and enables the measuring of characteristic behaviors. EFSim Test provides measured, objective results, and its tasks are related to a child's everyday behavior where potential ADHD traits are revealed," says Mikko Kontio, COO and co-founder of Peili Vision.
"Labquality provided us with support for building and maintaining the QMS, necessary documentation, and implementing the clinical study. Getting all these services from one provider is a significant advantage for us."
Conducting a clinical study for a Medical Device
Peili Vision has invested in academic research collaborations, but these alone are insufficient to obtain CE marking for a medical device under the MDR. Labquality conducted the clinical study of the EFSim Test following the turnkey model.
"We had no idea of the amount of work that would lay ahead and what kind of a rabbit hole we were looking into. However, the cooperation with Labquality has been smooth, and they controlled the project. Managing a clinical research project is so complex that you can't do it without previous experience," Kontio says.
Outsourcing clinical research allows Peili Vision to focus their resources on core activities such as product development, allowing them to avoid the challenges related to recruiting or managing an in-house senior researcher or CRO team.
Strategic planning of a clinical study for a Medical Device
Labquality supported Peili Vision in the strategic planning of the study. Several questions were addressed: These included research questions and gaps based on clinical evaluation, patient population, regulatory purpose, development plans, and strategic objectives. This phase also included study design, choosing endpoints, and statistical power determination. The study centers were selected and contracted. The fact that there were no comparator devices for the EFSim Test caused particular challenges. In such situations, open and fast communication between the CRO and the sponsor proved essential.
Planning and building a clinical research project
As the project progressed, plans for resource use and partnerships were made. In addition, the clinical investigation plan (CIP), necessary documentation such as consent (PIC, IB), and data collection tools (eCRF and ePRO) were created. Regulatory approvals and authorizations by competent authority (CA) and ethics committee reviews were crucial, not to forget the necessary risk management.
Implementation of the study
The implementation phase began with the opening of study sites and recruiting participants. Some of the visits were conducted remotely. Labquality managed data collection, quality assurance, safety monitoring, and reporting of the study.
Children as participants in the study
The clinical trial evaluates the efficacy of the EFSim Test in both children diagnosed with ADHD and typically developing children. When vulnerable subjects like children participate, the study becomes more regulated and demanding to conduct than with adult participants.
"We were familiar with working with children thanks to the NÄKY school projects, and we knew the children would be excited to use the test. But regarding regulation and data handling, working with children presented challenges for Labquality’s experts," Kontio notes.
Data protection, safety, and subject recruitment and informing them required special attention. Parental consent is mandatory when a child participates, and in this study, consent from participating children was also sought in an age-appropriate manner using language the children understood.
A clinical study provides credible evidence for a device
Research and utilizing the results are important for Peili Vision. Labquality analyzes and reports the clinical data collected after closing the database. In this phase, the clinical evaluation is completed. This phase also lays the ground for the expected publications that build on the study data, even though it was collected mainly to obtain the CE marking for the EFSim Test.
In addition to providing credible evidence, the study can benefit future product development. The study design ensures that the collected data can be used separately in academic research to deepen the understanding of executive function and ADHD-related issues.
About Peili Vision
Peili Vision is an Oulu-based software company founded in 2015, specializing in developing neurocognitive assessment tools that leverage gaming technology for educational and healthcare purposes.
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