B. Braun Transforms Global Clinical Trial Management for Digital Excellence

B. Braun, a leading medical technology company with over 5,000 products spanning devices and pharmaceuticals, transformed its global clinical trial management by bringing together technically diverse processes into one global source of clinical information.

Marius Selig, Director of Medical Scientific Affairs Aesculap at B. Braun shares key learnings and the impact of clinical digital transformation, which established a single source of truth, real-time data access, and standard operating procedures to help manage clinical research activities.

With increasing demands around study conduct, documentation, and sponsor oversight, B. Braun sought for opportunities to drive excellence in study management at global scale. The company was formerly reliant on manual processes spanning disparate solutions. To alleviate some of these matters, they had already championed multiple projects including:

• Implementing a consolidated database with basic study information
• Establishing a global medical scientific affairs network with annual surveys to monitor study activity
• Harmonizing study conduct with organizational guidelines and standard operating procedures across global B. Braun entities

These changes helped B. Braun address some of their core challenges, define clear objectives, and establish a baseline for scale. However, they still needed a single solution to unify their global clinical operations. Selig said, “We were already driving for standardization and cross divisional harmonization before moving forward with Veeva Clinical. Our SOP group was intentional in updating our SOPs prior to the implementation, allowing us to easily identify the SOPs that were most critical for our initial go-live with Veeva eTMF, Veeva CTMS and Veeva Payments. This streamlined our ability to set up the key workstreams and execute all SOP related activities in the project.”

To keep databases up-to-date, coordinate study approaches across divisions and regions, and optimize resource and time management they required a more efficient digital clinical solution.

“B. Braun adopted a global, cross-divisional approach for the implementation and customization of the system. We partnered with Veeva Clinical to train our project management team, enabling them to disseminate that information within their respective business units. This allowed us to get real-time feedback from our team and reflect unique business processes and requirements within the system.” – Marius Selig, Director of Medical Scientific Affairs at Aesculap.

While aligning the system requirements with their business needs, B. Braun evaluated the implementation process and impact on personnel. Selig emphasized the importance of taking a holistic approach and collaborating to maximize adoption and efficacy.

B. Braun also developed a comprehensive internal governance framework to establish autonomy and foster global adoption of the system. Selig said, “Governance is critical to a successful implementation. We created three governance levels within the project, including our core team that consisted of experts across our clinical divisions, a project steering committee, and an executive steering committee. We also included dedicated leaders responsible for different work streams, like IT, to cover all the aspects of the project.”

With clearly defined governance, B. Braun was able to closely follow their timeline, completed the implementation and formally launched in July 2022.

“The platform connects the B. Braun world of clinical studies. It is the single source of truth that provides an overview of worldwide clinical study activity, real-time access to clinical study data, and improves cross-functional collaboration.” – Marius Selig, Director of Medical Scientific Affairs at Aesculap.

B. Braun’s transformation enabled them to foster transparency and control while improving budget oversight and payment tracking with SAP integration. B. Braun identified the following key success factors:

1. Resources – defining capacities for key stakeholders and IT to ensure project success
2. Early education – for core team members to foster autonomy and improve adoption for additional stakeholders
3. Process definition – clearly defined SOPs prior to implementation to ensure new processes are standardized across the organization
4. Communication – coordinate internal and external communication to ensure transparency, avoid misunderstandings, and accelerate process development
5. Security matrix – allocate time to understand the security matrix and role models early in the process to avoid revisions after implementation

Moving forward, B. Braun is considering enhancements to their clinical infrastructure with tools including Veeva EDC and Veeva Site Connect. They also plan to establish KPIs to measure efficiencies as well as to implement additional reports and dashboards for their team and stakeholders.