Rapid deployment and secure operation through managed services

SynapCon's vision is to innovate the world of clinical trials. The company specialises in clinical IT solutions and consulting to manage the development of drugs and medical devices through IT-based management, ultimately supporting the digital transformation of medicine. In doing so, they offer added value to all stakeholders such as patients, physicians and payers through their digital health approach.

In addition to Study Site Selection, SynapCon's portfolio also includes easyTMF, a document management system for clinical trials. The system meets the daily requirements of clinical trials in a highly regulated environment. The software is available to customers as an on-premise or cloud solution.

SynapCon's requirement for the joint cloud project was to develop a highly secure and stable cloud platform through which customers could obtain the clinical trial data management software "easyTMF". Due to the use and storage of personal and health-related data of clinical trial participants, the security and DSGVO compliance of the platform was one of the key decision points in selecting the Amazon Web Services (AWS) cloud.

SynapCon offered its own IT product solutions on a pure on-premise level before the project started and therefore looked for a service provider that could not only build the AWS cloud platform but also operate it in the long term.

In particular, it was important to ensure that the service provider could guarantee fast response times in the event of incidents in the course of managed services in addition to monitoring and thus permanent performance monitoring of the platform.

We were called in as the service provider of choice and, based on SynapCon's requirements, developed a project plan that included not only the development of the cloud platform but also the managed services for permanent fail-safe operation.

For the development of the software systems themselves, SynapCon cooperated with another service provider. At the start of the project, the cloud experts at Innovations ON established direct contact with them so that all the requirements of the software itself could be taken into account in the development of the platform on which the software was to be operated in the future. This continuous exchange ensured that the software could be integrated without any problems or process interruptions once the platform was completed.

The platform itself was built in the public cloud of Amazon Web Services (AWS) and the infrastructure was provided automatically through templates, so that SynapCon can quickly provide the cloud environment including software to new customers in the future. This also ensures a uniform standard for all customers.

The development of the cloud platform was followed by the transition for the integration of the managed services. These are automated IT services that can be defined in advance in terms of type and scope and take over tasks such as monitoring, incident management, backup & recovery service, billing service and security services, as in the case of SynapCon. The managed services ensure permanent fail-safe operation of the AWS cloud platform and we operate them at SynapCon per customer either in the 8x5 (8 hours / 5 days) or 24x7 (24 hours / 7 days) model. We also act proactively here in order to be able to react quickly in the event of fault reports before an outage or shutdown occurs.

SynapCon is now able to provide its document management system for clinical trials "easyTMF" to customers not only on-premise but also in the public cloud of AWS via its own cloud platform. In doing so, all security and compliance guidelines are adhered to and personal data is processed in a DSGVO-compliant manner.

After building and developing the cloud platform, our team of experts continue to be responsible for its operation and use managed services for this purpose, with support models (8x5 or 24x7) individually adapted to the respective customer with a German operations centre in Ulm on the Danube.

SynapCon is now in a position to ensure rapid provision of the customer environment in the AWS Cloud and benefits from the continuous optimization of the cloud platform.

Updates of the "easyTMF" software are automatically imported in cooperation with the software development company and made available to all customers without downtime or delays.

By using backup & recovery management as part of the managed services, a backup of the customer's own environment is created in the cloud for each customer, which is automatically encrypted and therefore secure. Critical data from clinical studies, which play a relevant role in the development of drugs or medical devices, can thus no longer be lost and are kept safe.

Sven Engel, CEO, SynapCon GmbH:

"Together with our expert advisors, we have implemented our first project in the public cloud and, through the integration of managed services, we are now able to provide customers with our software products within minutes via our own secure and stable cloud platform."

Public Cloud Group (PCG) supports companies in their digital transformation through the use of public cloud solutions.

With a product portfolio designed to accompany organisations of all sizes in their cloud journey and competence that is a synonym for highly qualified staff that clients and partners like to work with, PCG is positioned as a reliable and trustworthy partner for the hyperscalers, relevant and with repeatedly validated competence and credibility.

We have the highest partnership status with the three relevant hyperscalers: Amazon Web Services (AWS), Google, and Microsoft. As experienced providers, we advise our customers independently with cloud implementation, application development, and managed services.