Agile Project Development for Pharma, Biotech and Medical Devices

The Agile methodology has had a significant impact on the software development and implementation in the Pharmaceutical industry whether it is Scrum, SAFe, Kanban, Lean or any of the many other frameworks. Conventions such as Daily standup, Sprints, Release Train, Retrospective and Timeboxing are recognized within the business departments outside of IT development to a greater extent. The iterative process is recognized worldwide as a contrast to the traditional waterfall methodology with longer planning and execution phases.

While the Agile Manifesto is clear in its tenets it can be difficult to implement it due to regulatory and documentationrequirements and conventional thinking. Therefore, it is important to understand where benefits can be reaped with Agile by utilizing the positive characteristics from various frameworks. HERAX utilizes the Agile methodology in all types of projects where it adds value as it is incorporated into our Pharma Business Architecture.

Agile in Pharma works, both in digital transformation and operational evolution. It’s a testament to the power of the approach that it can succeed in such a heavily regulated and specialized industry.

Analysis and
vendor selection

Contract and Planning

Process and Configuration

System Setup

Test and


Pharma Business Architecture®

Pharma Business Architecture Circle

The benefits of using HERAX are improved and sustainable operational processes, IT projects implemented on time and budget, with the right level of quality and compliance, using a life science specific agile project methodology named the Pharma Business Process Architecture.

HERAX focuses on assisting life science companies in defining a framework for decisions, implementing IT solutions and optimizing processes, while keeping attention on results and benefits.

By using our extensive best practice and IT implementation knowledge in our methodology, we help companies in the Life Science area to become more efficient and to get more value out of their clinical and operational IT budgets.

The agile methodology, now in version 4, is continuously updated based on the best practices being developed in new projects every day by HERAX consultants.   

How we work

We help our clients achieve lasting operational changes by providing extensive IT and pharma knowledge, experience and project methodology. At HERAX we believe in knowledge and delivering the best results for all projects. Through best practice cases and well tested methodology, we bring value and results for our clients in the Life Science industry.

How we work


Implementing an eTMF solution within 9 months


A leading European bio pharmaceutical company headquartered in Switzerland working with Fabry diseases and insomnia needed to implement an eTMF solution in 9 months.


Read the client case