Cases

It’s all about business processes and data for us. As an example, we have shared a few short case descriptions on this page, where we have supported Regulatory Affairs, Pharmacovigilance and Clinical Operations within the pharmaceutical industry.

We work in the dynamics between all stakeholders improving the quality of life for patients, why we have multiple angles on similar projects. Within the below mentioned cases, we have delivered process designs, use cases, requirement specifications and validation documentation, just to mention a few.

Our output focus is better quality of life for patients and benefit realization for other stakeholders. In most cases we also support the clients IT divisions/service providers, getting the most our of existing and new data, no matter the “system”. Please contact us for more (elaborated) cases or client references.

Improving data quality processes in Data Management

Introducing and configuration of new data quality processes and services to improve the work with clinical data quality. The work includes an improved business process as well a new tool to support and automate the data quality processes, supporting a more efficient way to meet the desired compliance level.

Resource optimization in Regulatory Affairs

An end-to-end “analyze – apply change – learnings & benefits” process, to eliminate bottlenecks and increase transparency on task allocation across RA, optimizing the use of the client resources. The project also included an introduction to new tools and new ways of handling data to support the new and changed processes.

Quality reporting in Pharmacovigilance

Ensuring patient is key both during pre product launch trials, as well post marketing studies. We have supported a sponsor improving the quality processes within Pharmacovigilance, going from meeting compliance demands, to improving internal quality processes and exceeding compliance demands, with less operational effort.

Process insights in Clinical Operations

Setting up a set of supporting data processes to support the continues business and process improvement, internally as well externally (Partners/CRO’s). The insights was released in sprints with a high frequency, to ensure swift business operational uptake, and immediate benefit realization.

Corporate Data Platform

Supporting the strategizing, governance, compliance and operational introducing of corporate GxP data platform to modernize and support digitalization across business areas. The project combines the best from two methodology dimensions, the Waterfall and Agile methodologies, to ensure most effective use of ressource and progress.