Web platform improvement for HealthCear Enterprise. CleanWeb™

They not only contribute to improving the quality and efficiency of medical care, but also provide higher coordination and a stronger focus on patients’ needs in a treatment process.

Our client is a bright representative of a corporate business organization with large-scale operations and business activities. They have their own product, which has been on the market for a long time and has already consolidated its leading position. Its main task is to provide medical staff with modern solutions to modernize their work processes. The platform allows patients to make appointments, conduct drug testing, interact with hospitals and, in general, covers a full range of services.

The joint project was aimed at improving and modifying the current platform, as well as at creating microservice solutions to complement and further replace the monolithic electronic control system. This was connected with the technical side, the speed and the cost of support, as well as with the search for opportunities and solutions aimed at meeting the multifaceted needs of the medical institution, optimizing resources and improving the quality of patient care services.

The goal of our joint project was to improve and adapt the current CleanWeb™ platform specializing in electronic management of clinical trials and registries. This platform includes the following solutions:

• Solutions for clinical research that optimize the internal processes of the medical institution and work with patients. The user can select the necessary modules and services depending on the complexity of the task and goals: electronic data and document management (eCRF, CTMS, eTMF), patient’s electronic consent (eConsent), medical visualization, data monitoring (rSDV), randomization, early access programs or programs aimed at patients whose conditions or diseases require special attention and care.
• CleanWeb-MAP early access programs are a solution that facilitates access to new treatments for eligible patients. It allows you to register doctors and pharmacists for each new product associated with the early access program.
• Patients’ pathway modelling VisionHM is a solution that allows you to plan, optimize and standardize patients’ management using medical protocols.
• Solutions for the registry of practices, observatories and databases that collect and analyse standardized data. These tools are a method of Continuous Professional Development (CPD) and allow you to objectively assess the quality of care, as well as monitor the measures taken to improve it.
• An integrated system for effective working process tracking, for employees’ time tracking, and for the automation of the payroll reporting process. Users can create calendar events, mark their tasks, assign priorities, and set deadlines. The system allows you to send email notifications, invitations to other users and notify them of upcoming meetings and tasks. There is also a built-in calendar of public holidays with automatic updating.

Ensuring information security and protection was a key aspect of this project. Therefore, the CleanWeb™ platform complies with the recommendations of GAMP-5, FDA 21 CFR Part 11 and ICH E6 (R2). Important data and communications are stored on confidential servers, access to which is restricted and protected by encryption. The daily creation of backups of the system and data in accordance with the privacy policy ensures the safety and accessibility of the platform by 99.9%. Physical access to the hosting infrastructure of the platform is allowed only to individuals having appropriate authority. To solve the problem of system overloading, we distributed the data among different servers, which prevented the need to stop all processes to update certain parts and increased work efficiency. Due to the microservice architecture of the platform, updates occur automatically and in a safe mode.

For users’ convenience, we implemented automatic notifications via SMS or email. This feature helps to support users in completing questionnaires and leads to a high average ePRO completion rate of 95%.

To personalize users’ work with eCRF, we developed Designer, the constructor function, which is installed directly on a user's device. It provides an opportunity for data scientists, project managers and clinical trial participants to fully customize the eCRF associated with a specific project, as well as perform automatic checks for consistency and behaviour compliance in real conditions. The Designer also allows you to manage updates that may occur during the project.

To ensure security and confidentiality, access to patients' personal data is provided after authentication and authorization, and in accordance with the user's profile and his/her authority. All the data is encrypted and stored on confidential servers, access to which is also limited.

Cooperating with enterprise companies requires a special understanding of their unique aspects. Integrating new technologies can be a difficult task and involves effective communication with the existing systems. Solutions are usually large-scale and require significant time and effort to be developed, implemented and maintained.

Our client was looking for a partner who could not only analyze and understand their needs, but also show flexibility in adapting to non-standard conditions and be ready to overcome difficulties in the process of cooperation.

We held several meetings with the client in order to fully understand their expectations and goals. Being a boutique company, our company was able to assure the client of a more individual and flexible approach. It was important for the client to see the knowledge and experience of those working on the project. Therefore, the personal participation of the company's CTO in the working process and their own expertise guaranteed high quality solutions and successful project implementation.

In this project, flexibility in methods and solutions became essential for quickly adapting to new tasks and effectively performing them. We chose the Scrum methodology to organize the development process. This solution allowed us to effectively manage tasks and maintain constant interaction between our teams. We actively held discussions on the implementation of integrations, made the necessary adjustments and took into account the received feedback. For the successful implementation of urgent tasks, we put extra effort working overtime. Due to our hard and intensive work, we were able to solve complex problems for which there had been no alternative solutions.

As technical experts, we were a key element in creating software solutions and configuring the platform for effective data management and processing in the project. Having in-depth expertise and a high level of the client’s trust, we played an important role in the process of modifying the existing CleanWeb™ platform for clinical trials and registries electronic management. This included supporting current products and addressing new challenges arising when making changes to the platform. It was only due to the professional and transparent interaction of our team with the colleagues within the framework of this project that we were able to implement the effective functionality of the improved modified existing system and the successful launch of new products.

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The Aionys team, together with the client, implemented effective optimization of the company's internal processes through the introduction of advanced technologies and methods to reduce costs and increase efficiency. This has enabled the allocation of additional resources to innovation projects, research, and the promotion of new products, ensuring the stability and sustainable growth of the company.

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Due to the cooperation with Aionys TELEMEDICINE TECHNOLOGIES S.A.S. managed to achieve the following results:

• The CleanWeb™ platform has been modified and improved for the electronic management of clinical trials, registries, early access and modelling programs, including appropriate QA processes and continuous partner’s support over a long period of time.
• The user-friendly and easy-to-navigate functionality of the platform has been developed, taking into account all the client’s requirements.
• Effective optimization of the company's internal processes has been achieved by introducing advanced technologies and methods, which reduced costs and improved efficiency.
• The possibility of allocating additional resources to innovative projects, of doing research and promoting new products has been implemented, which ensured the company’s stability and sustainable growth.
• The CleanWeb™ platform is certified by the international quality management system standard ISO9001:2015 and is recommended by the management of the standard for the validation of computerized systems in the pharmaceutical industry GAMP-5.