Climedo Builds Secure, Scalable Clinical Data Platform Using AWS

“Digital sovereignty means having full control over our data, infrastructure, and access policies,” says Dragan Mileski, cofounder and chief technology officer at Climedo. “Especially with respect to jurisdictional boundaries and compliance frameworks.”

The company chose to use Amazon Web Services (AWS) to build its EDC platform, working in the AWS Europe (Frankfurt) Region and with advanced data residency and encryption controls. With the ability to scale using AWS infrastructure, Climedo is rapidly growing its customer base, allowing organizations to digitize the clinical trials process while meeting requirements in their geographic region. It has helped public health officials reduce time spent tracking symptoms by 80 percent and increased patient completion rates to 90 percent through remote participation. All of which is resulting in higher-quality data, more successful trials for customers, and faster growth for Climedo.

Clinical trials need good data to produce valuable outcomes. One way to ensure this is to provide study participants with a convenient, user-friendly way to share data with those conducting studies, including medical device manufacturers, pharmaceutical companies, hospitals, and public health offices. These organizations can then access information through a centralized location that allows them to easily view the data.

Recognizing that many medical researchers used spreadsheets and paper-based systems to capture and manage clinical trial data, Climedo wanted to create a more efficient digital solution. But handling highly sensitive personal information required meeting strict data protection, residency, and access requirements.

“The AWS sovereign-by-design approach—such as customer control over data location, encryption, and access—played a key role in our choice of cloud provider,” says Mileski. A major consideration was the ability to protect our data. “We had to ensure end-to-end auditability, secure file uploads, role-based access, and the ability to manage user consent and data lifecycle transparently,” says Mileski. “We chose AWS because it helps us to meet data protection standards and provides the scalability we need.”  

Climedo used core services in the AWS Europe (Frankfurt) Region and based its data protection and security architecture on AWS Key Management Service (AWS KMS), with customer-managed keys to control access to encrypted data. The architecture has been successfully audited by multiple private and German government data protection and security institutions for compliance and is continuously updated to meet evolving requirements. “AWS is a great help,” says Benjamin Sauer, head of backend engineering at Climedo. “We have regular calls to discuss our goals. AWS helps us to problem-solve on everything from encryption and architecture to growing and scaling our company.”

Climedo’s EDC solution allows customers to conduct efficient, high-quality clinical research, including product registries, patient diaries, and feedback surveys. With it, organizations can access real-time insights, allowing them to react quickly and make better-informed decisions.

In Germany, public health offices used the company’s eDiary solution—which Climedo migrated to AWS—to capture and manage trial participants’ experiences during the COVID-19 pandemic. This helped them handle a large and sudden increase in workloads, replacing phone calls and visits with patients simply inputting symptoms directly into eDiary on their mobile devices.

Within 12 months of beginning the project, around 140 public health offices were using eDiary to keep an up-to-date view of potential COVID-19 cases. “We’ve made life much easier for public health officers, who were previously relying on fax machines and phone calls for tracking cases,” says Catherine Higginson, marketing manager at Climedo. “Officials reduced the time spent on tracking symptoms by 80 percent because, with eDiary, it’s fully automated. We’ve revolutionized their systems.”

Another Climedo patient diary solution—electronic Patient-Reported Outcome (ePRO)—proved useful when social distancing restrictions limited hospital access during the pandemic. The ability to provide data remotely meant more patients could participate in research, resulting in a 90-percent patient completion rate. “This decentralized approach puts patients at the center of the clinical trial process,” says Higginson. “Hospitals and other healthcare providers then benefit from a larger, more diverse group of trial participants, which leads to better clinical results.”

“The AWS sovereign-by-design approach—such as customer control over data location, encryption, and access—played a key role in our choice of cloud provider.”

Dragan Mileski, Cofounder and Chief Technology Officer, Climedo

With eDiary running on AWS, Climedo can support hundreds of thousands of subjects per study, compared to 500 previously. And, at the height of the pandemic, it was processing more than 30,000 SMS messages sent a day from public health offices to suspected COVID-19 patients. “AWS has given us the flexibility, performance, and access to data protection features that we need to deploy globally,” says Mileski.

Its ability to scale services for customers at pace has led to more customers and rapid growth, with the Climedo team quadrupling in size in 18 months. “Using AWS has made it a lot easier for us to win new customers,” says Mileski. “For us, and for them, having control over data will always be a top priority. We’re confident AWS will evolve with the European regulatory landscape and continue to provide services that align with our compliance and sovereignty needs.”