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Redenlab is a global leader in speech testing software for clinical trials. To meet medical device compliance standards like FDA 21 CFR Part 22, without losing operational flexibility, they use Jira, Confluence and Comala Document Control for Cloud.
Redenlab is a pioneer of new ways to test and analyze speech biometrics in clinical trials. Their solutions have been used to research conditions like Parkinson’s disease, dementia and depression. “It really comes from a desire to improve how drug companies measure the things that matter to people,” says Dr. Adam Vogel, Redenlab’s Founder and Chief Science Officer.
The company offers several software solutions for data capture, management and analysis that can be used both in-clinic and remotely. This includes a cloud-based portal for remote management and processing of large volumes of data, device agnostic web-based tools and mobile apps for recording at-home and in-clinic assessments, and Redenlab ANALYSE, a sophisticated data analysis pipeline. These solutions need to meet the stringent regulations that apply to medical devices, including FDA 21 CFR Part 22.
Redenlab uses Jira to manage their software development, and Confluence for their documentation and quality management system. “Our previous CTO, and one of the companies I used to work for, used Jira and Confluence, so it seemed like the obvious choice. Plus we’re fans of Mike and Scott – the Sydney-based Atlassian Founders,” says Adam. With customers in 11 countries, and employees around the world, Redenlab also wanted a solution that was mobile and cloud-based. “We never looked at any other products besides Atlassian. The model really fits the dynamic nature of our company. Because we’re small and agile, we can move quickly.”
Confluence provides a central workspace for creating and storing documents, that is easily accessible to the whole team. Multiple users can work on a document at the same time, and Redenlab uses templates to streamline the creation process. Another major appeal of the platform is the ability to integrate different processes together. Software requirements written in Confluence are linked directly to issues in Jira, while tasks related to documentation can be tracked through Jira’s project management tools.
“It really speaks to being a company situated in multiple environments, and allows us to work in remote setting quite easily and flexibly,” says Dr. Michelle Magee, Redenlab’s Senior Quality & Data Manager. “And with the incorporation of Comala Document Control we are also able to meet compliance aspects.”
For a health analytics company, that ability to manage documents in multiple stages and have sign offs is key to achieving standards like FDA 21 CFR Part 22. While there were several external compliance programs that fit the bill, Redenlab wanted a solution that integrated smoothly in their Atlassian environment. Their team reviewed the available apps for Confluence, evaluated some of them, and ultimately settled on Comala Document Control. “Comala Document Control allowed us that environment, with clear stages in a document’s lifecycle, drafts, and electronic signatures,” Michelle says.
Redenlab uses the Quality Management System workflow, one of three built-in workflows that comes with Comala Document Control. Organizations can also design their own custom workflows, but for many, these three templates are enough to achieve their goals, including many compliance regulations.
The Quality Management System workflow begins with the document in a Draft state, which must be approved or rejected by one or more assigned reviewers. All reviewers are required to enter an electronic signature. Once it’s approved, it will move to the In Approval state. Here the document undergoes another round of approvals from one or more assigned reviewers. Finally, if given the okay, it will go to the Published state. Any later changes to the document after it has been finalized will revert the it to the Draft state. At either the draft or the published state a reviewer can reject the page to send it to the obsolete state, letting team members know it will no longer be updated and is ready for archiving.
With Confluence and the QMS Workflow, Redenlab has set up an environment where several team members can come together to work on a draft. The document can then go back and forth through multiple rounds of revisions and reviews until it is finally signed off by the department lead and CEO.
With over 100,000 recordings made, and 200+ peer reviewed publications utilizing their solutions, Redenlab is leading the way in speech biometrics. Using Confluence, Jira and Comala Document Control, they are able to integrate their software development, project management, documentation, and onboarding, while meeting stringent compliance requirements.
“We’re really happy with the product. It’s not too cost prohibitive, and it integrates really well into the system,” Adam says. “We’ve been using it for a year and a half now. Our money and loyalty is proof we’re happy. We also really like the way it’s constantly being updated and adapting. It allows for a really adaptable system, as our company grows.”
To learn more about Redenlab, visit their website. You can learn more about Comala Document Control and get a free trial from the Atlassian Marketplace. Special thanks to @Adam Vogel and Michelle Magee from Redenlab.