Case Study Header 2024 Clinical Safety

Consolidating for Efficiency.
How Centralized Management Improves Clinical Safety.

Client type:

Biotech.

Geography:

US/EU.

Lifecycle stage:

Clinical Development (Phase I & II).

Service area:

Clinical Safety.

Summary.

  • Safety data migration and consolidation

  • Full clinical safety outsourcing.

  • Safety database provision and maintenance.

  • Improving communication, consistency, and efficiency.

Challenges.

A US based biotech company was managing a complex portfolio of clinical programs in Phases I and II across multiple CROs. The company’s small internal PV department required a single provider to centralise and manage all safety activities across all programs. 

With multiple active trials with study sites ranging from seven to 10 countries in EU and North America, the client had previously engaged multiple service providers to support clinical safety activities. These activities included end-to-end case management, expedited SUSAR reporting, DSUR production and submission and the production and maintenance of SMPs (Safety Management Plans). The duplication of vendors increased complexity for ongoing benefit risk assessment for the product due to the need to aggregate and assess data from different sources. It also resulted in project inefficiency, with a fragmented approach to stakeholder communications, an increased number of extended stakeholders and overall, a more complex and lengthier process than necessary impacting overall project costs and risking compliance.

Solution.

The Arriello team evaluated the existing PV setup and prepared a process to take each of the trials and transition them across into a single safety database (Veeva Vault Safety) with oversight performed under one safety governance process. The ongoing growth of this database is now a simple parametrization task which can be completed in hours and not days. It provides system flexibility and cost efficiency for data management (data export and import) and is fully scalable and flexible for company growth. All this is contained in a partitioned client database in a secure environment – managed by Arriello’s IT team. 

The team started by preparing clinical trial specific SMP documentation to overcome immediate time constraints. Creating a Master SMP and gaining approval for that across multiple stakeholders and countries greatly sped up the preparation and review process for individual trial SMPs. 

By transitioning to one, holistic, central point of contact the client consolidated their approach, improved the quality and consistency of their safety data, refined and simplified responsibilities and centralized visibility of data and decision making. Arriello partnered with them, and as new trials were established this model could be applied and the client benefited from scale and consistency of operations, ensuring the SMPs were aligned, the reporting was consistent, reliable and easy to understand, and their management time was minimized.

Our Holistic Approach.

The Arriello approach was to transition and manage the project in a proactive, flexible manner, taking responsibility for ensuring high quality safety data to support benefit risk assessment, regulatory compliance for expedited and aggregate reporting and efficient communication of safety data across stakeholders.

During the process, we provided consultancy and guidance where needed along with a clear framework and transition plan, to ensure our client had all the clinical safety support it needed.

Arriello then provided regulatory intelligence updates and impact assessments for changes in regulatory requirements which subsequently affected our client’s portfolio and business. They gained country-specific insights that reduced their risk, allowing them to respond in a timely manner to changes that impact their clinical trial safety data.

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