Software development for Heacon Service GmbH
Heacon Service and pharmacovigilance management
Heacon Service GmbH is a medium-sized management consultancy in the healthcare sector offering services in audit management, market management and pharmacovigilance management. The 35-strong, interdisciplinary team combines many years of professional expertise with in-depth industry know-how. For over 30 years, Heacon Service has been supporting clients with practical experience, specific tools and entrepreneurial vision, from concept development to implementation.
Project teams are put together individually according to the task at hand. More than 500 clients from various segments of the national and European healthcare market, including pharmaceutical companies, hospitals, medical device manufacturers, research institutes and laboratories, have placed their trust in Heacon Service in recent years.
The World Health Organisation (WHO) defines pharmacovigilance as a science. Pharmacovigilance refers to all activities involved in monitoring the safety of medicinal products and identifying and preventing drug risks and side effects in clinical trials and after marketing authorisation.
The range of services offered by the Pharmacovigilance Management business unit includes
- the operation of an E2B-compliant database for the electronic reporting and management of side effects (Pheda database) to the drug regulatory authorities,
- continuous literature research and evaluation,
- the preparation of Periodic Safety Update Reports (PSURs) and signal detection reports,
- the performance of ‘friendly audits’,
- the provision of Standard Operating Procedures (SOPs) and
- the coaching of pharmacovigilance staff.
Here you will find more information about Heacon Service GmbH.
The starting point and development of PhedaLit
Heacon Service wanted to modernise the software for continuous literature research and evaluation of adverse reaction cases and safety-related publications. The aim was to develop a new database to replace an outdated legacy system and reliably monitor the benefit-risk profile of medicinal products.
The new literature database had to do two things:
- It had to support the scientific evaluation and management of analysed data.
- And it had to provide data fields required by regulations, enable clean exports for further pharmacovigilance evaluations, simplify administrative processes and offer a customer interface with email functionality.
After the specification phase, Heacon Service sought a suitable IT service provider for development in the regulated environment. Documentation, validation and transparency at every stage of development were top priorities.
Through internet research, Heacon Service came across t2informatik in Berlin. After initial discussions and successful supplier qualification, the collaboration began. From the outset, open communication, short channels and a quick understanding of the technical requirements characterised the collaboration. Regular meetings kept everyone on track. Mock-ups made decisions tangible. Detailed documentation in Confluence ensured clarity and traceability.
For the implementation, t2informatik used an in-house REST API framework, significantly reducing the development effort. At the same time, a proprietary migration tool was developed, which was built iteratively and used during development. The front end was created with Angular and Angular Material. A code generator from the REST API framework automatically created the client connection to the interface. A key feature of the application is its highly flexible search function with numerous criteria. It responds to queries efficiently and makes working with data noticeably easier. In addition, the team integrated an email notification system into the existing infrastructure.
All development candidates ran in a test system and were thoroughly tested there. The biggest challenge was the clean allocation and migration of legacy data to the new database system. After successful validation and training for all employees, the new database went live in April 2024. Since then, administrators and customers have been working with it on a daily basis.
The result of this collaboration is called PhedaLit. The new database is powerful, validated and tailored to the daily work of the pharmacovigilance team. It provides relevant information quickly and reliably and makes collaboration with customers easier and more effective. This is what modern product development in a regulated environment feels like.
‘With the help of the expert team at t2Informatik, we were able to implement our software project quickly and efficiently. The collaboration was very constructive, and the tools used ensured that our documentation requirements for software validation were met from the outset.’
If you are planning a project or want to refine an idea, we would be happy to discuss it with you.
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