Software development for Heacon Service GmbH

The starting point

Heacon Service wants to modernise its software – an application for continuous literature searches and the assessment of adverse event reports and safety-related publications. The aim is to develop a new database that will replace an ageing legacy system and reliably monitor the benefit-risk profile of medicinal products.

The new literature database is intended to achieve two things:

• Support the scientific evaluation and management of analysed data.
• Provide data fields required by regulators, enable clean data exports for further pharmacovigilance analyses, simplify administrative processes and offer a customer interface with an email function.

The search for a partner

Following the specification phase, Heacon Service sought an IT service provider with expertise in development within regulated environments: documentation, validation and transparency at every stage of development were given the highest priority. Through an online search, the company came across t2informatik in Berlin. Following initial discussions and a successful supplier qualification process, the collaboration began.

From the outset, the partnership is characterised by open communication, short lines of communication and a rapid understanding of the technical requirements. Regular meetings keep everyone on track, whilst mock-ups make decisions tangible. Detailed documentation in Confluence ensures clarity and traceability.

Implementation

For the implementation, t2informatik uses an in-house REST API framework, thereby significantly reducing development effort. At the same time, a proprietary migration tool is being developed; this is built iteratively and is already being used during the development phase. The frontend is built using Angular and Angular Material. A code generator from the REST API framework automatically generates the client connection to the interface.

A key feature of the application is its highly flexible search function with numerous criteria. It responds efficiently to queries and noticeably simplifies working with the data. In addition, the team integrates an email notification system into the existing infrastructure.

All development candidates are subjected to intensive testing in a test system. The greatest challenge lies in the clean mapping and migration of legacy data into the new database system. Following successful validation and training for all staff, the new database goes live in April 2024. Since then, administrators and customers have been working with it on a daily basis.

The result

The result of this collaboration is called PhedaLit. The new database is powerful, validated and tailored to the day-to-day work of the pharmacovigilance team. It provides the relevant information quickly and reliably, making collaboration with clients easier and more effective. This is what modern product development in a regulated environment feels like.

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.