Scientific Data Management System

We care

A global pharmaceutical company aimed at digitizing the outputs of its laboratory scientific measurements. Prior to the project, the measurements were recorded on paper and disparate instrument-specific systems, which brought human error, inefficiency and increased consumption of resources. The challenge of the large digitalization project was to implement a common solution used in laboratory sites around the world, get local teams engaged in the change process and coordinate with other digitalization projects that run at the same time.

We act

Our expert had a double-role as IT project lead and Scrum Master. As the IT project lead, we planned the IT resources and required budget, managed the project stakeholders including internal IT teams, business and external IT vendors. As part of the Scrum Master role, we ensured the development team has the best conditions to work in Agile methodology and enabled project members to work better together.

We deliver

The project achieved the digitization of scientific laboratory work in 6 sites across 3 countries in Europe. The project is ongoing, and additional 14 sites are planned to be digitized until 2027.

Dashboard Analytics and Reporting Tool

We care

The sustainability and quality department of a global pharmaceutical company sought to improve its analytics and reporting capabilities by creating visual and easily understandable reports in Qlik. To achieve this, it was necessary to onboard interested stakeholders, ensure the data transfer between different databases and develop tailored visual reports.

We act

As IT project leader, we were responsible for budgeting, creation of project plan and reporting. We also took care of the coordination between different stakeholders in the project - including internal database team, external developers and the internal clients for whom the dashboards are being developed.

We deliver

The project is ongoing and so far 8 dashboards have been created and are in use by internal clients. Examples of reports created include security audits, environmental safety and learning.

Global Value Chain Reporting Solution

We care

A pharmaceutical company sought to improve enterprise steering and the decision making process by achieving greater transparency on margins per product and enable controllers to leverage trade margin data as a key operating principle to drive profitable growth. The challenge of the project was to establish a solution that automates data collection from different ERP systems, and value chain generation and validation.

We act

Our expert served as IT Project Leader during the feasibility study and subsequent solution implementation project. We were responsible for project preparation & project planning, as well as budget management and steers of external suppliers & IT departments working for the project. We supported the Product Owner in scope management and acted as first escalation instance on IT related topics. We worked in closely and ensured alignment with purchasing, IT boards, and other projects / initiatives.

We deliver

The company now has in place an on-premise SAP plug-in solution that allows data extraction from viarious SAP systems, and detailed calculation of global product cost along the global production and supply chain with millions of data points.

Intercompany Invoice Processing Solution

We care

The Finance department of a global pharmaceutical company aimed at optimizing and harmonizing their cross-charging process on a global scale. The challenges of the initiative were to establish a request template integrated with the comapny's finance portal and data mapping and validations for invoices, as well as the creation of journal entry files and workflow functionality for invoice processing by different teams located globally.

We act

As IT Project Leader, we created, maintained and owned the integrated project plan and the solution delivery. We took responsibility for IT resource planning and staffing​ as well as managed communication with project team and stakeholders . We ensured on-time and on-quality execution of tasks and achievements of milestones​, while managing risks, issues and resolutions​. We also managed vendors and took accountability for the IT project budget controlling​, and ensured handover of the solution to IT Operations.

We deliver

The company now has in place an automated process built on K2 Technology with workflows that ensure correct accounting and clarity of financial statements, as well as transparency of global charges and intercompany agreements.

Global Clinical Data Repository (GxP)

We care

In line with adjusting their operational model for executing clinical studies internally and with external partners, a pharmaceutical company chose to reduce technical liability by implementing a new clinical data repository (CDR). The legacy system was highly customized and increasingly difficult to maintain. Systems supporting the execution and analysis of clinical studies underly Good Clinical Practice (GCP) regulatory requirements with the associated need for thorough change control. The system replacement was affecting a central component of the customer's value chain with the according management visibility and impact on project participants' targets.

We act

As IT project leader we were managing a global team across the US, UK, Germany, China and India, with technical and business resources spread across all involved locations. The project was divided into 12 work streams, each co-led by a business and technical representative. The successful execution of the project required a high level of transparency and coordination across workstreams, particularly regarding development, documentation and deployment milestones and the organizational change management. The IT project lead was responsible for maintaining the project finances and oversee supplier contracts and related reporting and invoicing. Regular steering meetings with higher management were prepared and executed to share updates on project progress and seek guidance on critical questions to align department strategy with the project implementation.

We deliver

The project went live with a first release including a pilot set of active studies that will be executed within the new system and ready to host any newly initiated studies. Migration of locked and active studies from the legacy system to the new will be addressed in a second release, together with functional enhancements.

Quality Management System for R&D (GxP)

We care

Within a pharmaceutical company the QMS processes and related documentation for R&D was dispersed across multiple IT systems and Excel tools. Moving towards a largely standard cloud solution was planned to foster collaboration, transparency and standardization and thus lead to significant quality improvements and efficiency gains, while observing and supporting good practices (GxP) prescribed by regulators and legislators.

The project was planned to deliver following an agile approach with multiple business work streams and a unified team of application consultants from the system supplier.

We act

As the IT project lead we were responsible for the integrated project plan, budget and resourcing. We managed the timely delivery of the key project milestones within budget and quality. Contributing to the project success was the tight collaboration with business and supplier resources and interpreting between the spheres. Actively supporting the accompanying change management initiative helped continual improvement during the agile implementation and finally fast system adoption by users.

We deliver

The project delivered a key digitalization goal, reaching a new maturity level of their R&D quality management system. The project acted as a pilot for taking central, regulated systems into the cloud thus leveraging cross-industry standards and reducing maintenance cost.