Orthofix: when a Medical Device company meets the right EDC

Dec 2, 2021 | CASE STUDIES

Introduction

Symphony is the data capture system developed by Arithmos and used by numerous pharmaceutical, biotechnology, medical device, universities and non-profit organisationssince 2013. Symphony was created to provide a unique customer experience as a user-friendly tool with which users can manage and configure their data collection system autonomously.

Symphony EDC accelerates the overall data collection and data management process with its intuitive and powerful features.

Background and challenges

Orthofix is the 8th largest Orthopedic Medical Device company in the World[1], with more than 1,000 employees dedicated to developing, manufacturing and distributing of diverse product lines in more than 60 countries worldwide. 

Orthofix, the first client of Symphony EDC, has been using the system since 2013. The goal of Orthofix was to move to a scalable, reliable and cost-effective EDC system without compromising their management and administrative control over the process. Symphony was the perfect match as it offered complete independence while building and managing the studies, accelerating trial timelines and combined it with high data security levels. 

Arithmos’ Approach

In order to satisfy Orthofix’s needs, we have offered the following approach:

  • For a flexible technology infrastructure, Symphony EDC SaaS model was suggested.
  • For an autonomous management, Administrator Manual was provided. The Manual contained multiple examples of pages configuration and edit checks to increase the autonomy of the client’s team.
  • Administrator training was done, so itprovided the necessary skills to the clinical study team to build studies autonomously and program the edit checks. The training lasted two days and allowed team to learn how to configure Symphony independently without technical knowledge.
  • For an on-demand additional capacity,Managed Services were definedthat allowed client to take advantage of Arithmos support when additional capacity for the configuration of eCRFs was needed.

Inclusion of the trainings and manuals were crucial for the EDC package cost reduction, as it allowed the client to become independent and autonomous very quickly and optimise time spent on building and managing studies.

In 2017, a new module for Symphony was released. The Reports & Listings module allowed Orthofix to create predefined reports that further increased the independency of the client and optimised the work process.

In addition to that, another unique module of Symphony was introduced in 2017 – the eLearning module for end users and CRAs which allowed tracking the learning progress of the users and issuing training certificates.

Success factors and outcome

Orthofix has been using Symphony EDC for 8 years. We managed to guarantee high level of satisfaction thanks to the combination of the right price and functionality that perfectly fits the needs of the client.

In summary, what made Symphony EDC a successful solution for Orthofix was:

  • Scalability: the number of studies has been increased effortlessly.
  • Simple Study Design: the eLearning module that provided autonomous training ensured fast and effective training for final users without technical skills.
  • Reporting: a high flexibility was achieved thanks to the reporting module for tracking the status of the study which included pre-set reports and allowed creation of new customised reports.
  • SaaS model: the client has outsourced the IT infrastructure, including disaster recovery and security management of the EDC system by using Arithmos SaaS Symphony model.

Orthofix is the leading medical device company committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organisations to meet the needs of their patients every day.

At Arithmos we are delighted to use our technology and industry knowledge to help Orthofix to deliver therapeutic solutions to patients in a smart and cost-efficient manner.


[1] by Medical Design & Outsourcing magazine.

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