In April and July 2024, Lambda successfully managed over 6,800 Individual Case Safety Reports (ICSRs) in two separate bulk submissions for a Marketing Authorization Holder (MAH) from India. Each case batch required efficient processing, meticulous data migration, and timely submission to the Indian regulatory agency within tight deadlines. By employing a combination of automated tools, a structured Data Migration Plan (DMP), and close collaboration with a database service provider, Lambda achieved 100% compliance for both submissions.
This achievement not only underscores Lambda’s operational excellence but also demonstrates its capability to handle large-scale pharmacovigilance requirements under strict regulatory timelines.
Project Details
Objectives:
- Achieve 100% compliance with regulatory timelines.
- Efficiently process high volumes of ICSRs received in bulk from the Indonesian regulatory authority.
- Ensure accurate data migration and timely submission to the Indian regulatory authority.
Bulk Submission 1: Handling of 4652 ICSRs
Case Details:
- Date of Receipt: April 30, 2024 (by MAH)
- Submission Deadline: May 29, 2024
- Date Sent to Lambda: May 7, 2024
- ICSR Breakdown: 4600 initial cases, 52 follow-ups
Process Flow:
- Regulatory Submission – All ICSRs were processed and submitted by the regulatory deadline of May 29, 2024.
- Initial Assessment – Lambda quickly categorized the ICSRs, identifying 4600 as initial cases and 52 as follow-ups.
- Data Migration Plan (DMP) Development – A DMP was formulated, leveraging automation developed by a database service provider, ensuring efficient data handling.
- Data Migration Execution – The data migration was carried out in two phases:
- Validation Environment – Migration was first conducted in PvEdge’s Validation environment to ensure data accuracy.
- Production Environment – Following successful validation, the migration proceeded in the Production environment on PvEdge.
- ICSR Processing – Cases were created in the safety database by May 22, 2024.
Lambda reported all 4652 cases to the Indian regulatory agency on time, achieving 100% compliance.
Bulk Submission 2: Handling of 2219 ICSRs
Case Details:
- Date of Receipt: July 19, 2024 (by MAH)
- Submission Deadline: August 18, 2024
- Date Sent to Lambda: July 26, 2024
- ICSR Breakdown: 2179 initial cases, 40 follow-ups
Process Flow:
- Initial Assessment – Lambda categorized the cases, identifying 2179 as initial cases and 40 as follow-ups.
- Data Migration Plan (DMP) Development – The DMP was tailored for this batch, leveraging the same automation and provider support as in the first batch.
- Data Migration Execution – Two phases were completed:
- Validation Environment – Initial migration in PvEdge’s Validation environment to verify data accuracy.
- Production Environment – Final migration into the Production environment on PvEdge.
- ICSR Processing – Cases were entered into the safety database by August 13, 2024.
- Regulatory Submission – All cases were processed and reported by the regulatory deadline of August 18, 2024.
Lambda successfully reported all 2219 cases to the Indian regulatory agency on time, maintaining 100% compliance.
Key Success Factors
| Structured Processing Workflow: |
| Lambda’s experienced pharmacovigilance team applied a systematic workflow, ensuring both initial and follow-up cases were processed correctly. |
| Efficient Data Migration Planning: |
| A robust DMP, supported by automation, enabled seamless data migration and minimized manual intervention. |
| Regulatory Timeliness and Compliance: |
| Both bulk submissions were completed ahead of regulatory deadlines, achieving 100% compliance with no delays or errors in reporting. |
Lambda’s ability to handle large-scale pharmacovigilance data within compressed timelines showcases its robust operational capabilities and commitment to regulatory excellence. By ensuring timely processing, precise data migration, and successful regulatory submissions, Lambda demonstrated its readiness to manage high-volume ICSR cases efficiently, reinforcing its reliability as a trusted partner in pharmacovigilance.
Extensive Experience:
Lambda Therapeutic Research provides comprehensive drug safety & pharmacovigilance services, encompassing all clinical and post-marketing phases. Our well-established PV framework ensures thorough safety monitoring and regulatory compliance for both clinical and commercial products, offering end-to-end support across the entire life cycle of medicinal products.
