Overview of Pharmacovigilance Case Migration Services.
Our pharmacovigilance case migration services ensure the integrity and security of your safety data during the transition to a new system. We specialize in migrating Individual Case Safety Reports (ICSRs), Aggregate Safety Summaries (ASSs), Clinical Data Interchange Standards Consortium (CDISC) data, and legacy systems, all while adhering to stringent regulatory requirements.
What we offer:
- Expert-Led Migration: Our team of seasoned professionals has extensive experience in pharmacovigilance data migrations. We possess a deep understanding of complexities like data heterogeneity, mapping requirements, ICH guidelines, and regulatory compliance. We will craft a customized plan tailored to your specific needs and data environment.
- Unwavering Data Integrity: We prioritize data integrity throughout the entire process. We employ industry-leading practices to guarantee the accurate and complete transfer of your data, encompassing ICSRs, ASSs, CDISC data, and legacy systems.
- Guaranteed Regulatory Compliance: We stay current on all relevant pharmacovigilance data migration regulations, including ICH guidelines. We’ll guide you through the process, ensuring your migration adheres to all applicable regulations.
- Minimized Disruption: We understand downtime is a critical concern during a migration. We’ll work collaboratively with you to develop a plan that minimizes disruptions to your day-to-day operations.
Our Streamlined Migration Process:
Our efficient and effective case migration process is built on close collaboration. Here’s a breakdown of the typical steps involved:
- Comprehensive Planning: We conduct a thorough needs assessment to develop a detailed data migration plan. This plan includes a meticulously crafted data map outlining how data will be transformed from your source system to the target system.
- Secure Data Extraction: We securely extract your data from your existing system, encompassing ICSRs, ASSs, CDISC data, and legacy systems.
- Meticulous Data Transformation: We meticulously transform your data to ensure compatibility with your new system’s requirements. This may involve mapping data to different formats or standards.
- Streamlined Data Loading: We seamlessly load your transformed data into your new system.
- Rigorous Data Validation: We conduct rigorous data validation to guarantee the accuracy and completeness of the transferred data.
Additional Services:
- Pre-Migration Assessment: We can conduct a pre-migration assessment to evaluate the complexity of your migration and provide you with a cost estimate.
- Ongoing Support: Our team is available to provide ongoing support throughout the entire migration process and beyond.
Benefits of Utilizing Our Services:
- Reduced Risk of Errors: Mitigate the risk of data errors and omissions during the migration process.
- Enhanced Data Quality: Experience improved data quality and consistency within your new system.
- Increased Efficiency: Boost your efficiency and productivity by streamlining your pharmacovigilance data management.
- Reduced Costs: Minimize the costs associated with data migration through our efficient processes.
- Unwavering Regulatory Compliance: Ensure your pharmacovigilance data adheres to all applicable regulations.
The Migration Process.
- Assessment and Planning: First, we will conduct an assessment of the existing data and identify the scope of migration. This will involve mapping the current non-E2B data to the DB fields (if any).
- Data Preparation: We will clean, format, and validate the source data to ensure it meets E2B compliance requirements. This will involve data transformation and quality checks,
- Test Migration to Validation System: A test migration will be performed to validate the process and identify any potential issues. This step helps ensure that the migration is error-free.
- Validation and Reconciliation: Data migrated will be validated and reconciled to confirm that it aligns with the original source data. Any discrepancies will be addressed promptly. Within this step we will ensure that we have audit and inspection validation documentation ready.
- Full Migration: After successful testing, we will proceed with the full migration to the production environment. Data may be delivered in multiple phases (stages) through the project duration to ensure a smooth transition of the whole data set in one single bulk import and during non-working hours.
What our clients say about us.
KalVista Pharmacovigilance
Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire.
Cinfa Laboratories, Spain
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
Aspen Pharma Trading Limited
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.
Selected PV Case Studies.
Pharmacovigilance system, Europe, Local and global PV
Oncology pharmacovigilance, Pharmacovigilance transition, Clinical development safety
