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Customer Overview
A leading CRO, specializing in managing large-scale pharmacovigilance (PV) studies, was tasked with running a complex post-marketing safety study for a global pharmaceutical client. To ensure compliance with evolving regulatory demands and streamline operations, the CRO turned to Cloudbyz for an integrated pharmacovigilance (PV) solution.
Challenges
The CRO struggled with several challenges due to manual safety data management and disconnected legacy systems, leading to inefficiencies in processing serious adverse events (SAEs) and safety reports. The lack of real-time visibility across multiple sites and geographies made it difficult to meet strict regulatory timelines, while duplicated efforts increased operational costs. Additionally, siloed safety data from various sources hindered effective collaboration with sponsors and partners, further complicating the study’s management.
- A centralized PV system to unify safety data and streamline global study operations.
- Compliance with global regulatory standards, including FDA, EMA, and other local requirements.
- Real-time visibility and reporting to improve study oversight.
- Automation to accelerate safety report processing and reduce manual errors.
- Seamless collaboration between internal teams, sponsors, and external stakeholders.
Solution
The CRO implemented Cloudbyz’s unified Safety & PV database, built on the Salesforce cloud platform, to efficiently manage all aspects of the post-marketing PV study. The solution provided comprehensive safety data management, integration with MedDRA and WHODrug coding dictionaries, and automated safety report generation.
Benefits
With Cloudbyz’s Safety & PV solution, the CRO gained full visibility across all study sites, enhanced safety reporting accuracy, and ensured compliance with global regulatory requirements. Key benefits include:
- The CRO reached 90% compliance with US safety reporting timelines, ensuring timely and accurate safety submissions.
- Audit preparation time was reduced by 30%, improving overall compliance efficiency and reducing operational costs.
- Audit response times improved by 20%, enabling quicker and more precise submissions during regulatory inspections.
- The CRO successfully processed 87% of ICSRs for SAEs within 5 to 7 days.
Additionally, the Cloudbyz system allowed the CRO to easily collaborate with the pharmaceutical client and other partners by providing real-time data sharing and inspection-ready documentation. The system also complied with all major regulatory frameworks, including FDA 21 CFR Part 11, GCP, GAMP5, HIPAA, and EU-GDPR, ensuring that all data handling was secure and compliant.
By adopting Cloudbyz’s Safety & PV solution, the CRO successfully managed a complex, large-scale post-marketing PV study, ensuring timely and compliant safety reporting while reducing operational inefficiencies. The centralized, automated platform empowered the CRO to deliver high-quality safety data and meet regulatory demands across multiple regions, strengthening its partnership with the sponsor and enhancing overall study outcomes.
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