The client wanted to move from 100% paper CRFs to 100% EDC for new trials, with the data integrated into their Clinical Data Management System for creation on raw SDTM analysis files. The goal was achieved in 10 months, from initial idea to go-live, and reduced the time from LPLV to database lock to 2 weeks.
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.
Contract and Planning
Process and Configuration
Pharma Business Architecture®
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.
Customer Success Stories
EDC Selection & Implementation
Developing a complete process framework
The client’s business had rapidly expanded over the last ten years and was now facing the challenge of a fragmented and cumbersome SOP landscape with no overall structure. They needed to develop a new optimized and aligned framework that was scaled to match the pharmaceutical company they...
CTMS strategy, selection and implementation
The company needed to align the processes in all 4 divisions, and create a consolidated view of all trial planning and execution activities. Implementing best practice for RBM in order to save time for monitoring, giving the capability to run more trials with the same staff. Migration of old legacy systems, new processes...
Clinical Portals strategy, selection and implementation
The client needed one place for all study teams to work and share files and operational information for studies being run internally and outsourced to CROs. In order to support all study scenarios, a flexible portal with modules was needed. Analysis and strategy were done in 3 months, and the first trial...
Midsized pharma client implemented eTMF within 9 months
Client wanted to spin out it’s drug discovery operations into a new company within a strict timeline. This included transition of a number of studies and associated documents to a new integrated eTMF solution fully applying to DIA reference model 3.0, with no or limited time to fail
Statistical Computing Environment, MDR and new processes
The client was struggling with
local installations of statistical programming tools making it difficult for the IT department to manage and support. The statistical programmers experienced slow connectivity to data which resulted in local copies of programs and datasets. Cumbersome manual processes for data access...