Case Processing
Most providers focus on volume and speed. That might work for generics and large pharma, but it falls short when your cases require well-written narratives, medical & scientific insight, and attention to detail. We take a different approach: we specialize in quality, precision, and expert-driven case processing, ensuring that even the most challenging cases are handled with accuracy and efficiency.
- Safety Mailbox Monitoring
- Case Intake & Triage
- Data Entry
- Case Narrative Writing
- Quality Control
- MedDRA and WHO Drug Coding
- Medical Review
- Regulatory Submission and Distribution
- Query Management and Follow-up
- Reconciliation
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Specialized in Biotech & Complex Cases
- We specialize in supporting biotech companies developing innovative, high-risk therapies, including biologicals, ATMPs and orphan drugs. Our tailored approach ensures precise, scientifically driven processing of complex safety data, maintaining the highest standards of accuracy and insight.
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Expert-Led Case Processing
- Our team of pharmacists and MDs brings deep scientific and regulatory expertise to every case. With precise medical interpretation, comprehensive narratives, and strict compliance with global pharmacovigilance requirements, we ensure accuracy and excellence in case management.
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Less Oversight, More Confidence
- Our rigorous quality control ensures a high first-time approval rate, significantly reducing the need for in-house reviews and corrections. This guarantees seamless case processing while allowing your PV team to focus on strategic priorities with complete confidence.
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Dedicated Team, Seamless Integration & Adaptability
- We align our operations with your workflows, seamlessly integrating with your team and processes. A dedicated team of case processors remains consistently assigned to your project, developing deep familiarity with product specifics, processes, and stakeholder communication - ensuring sustained best practices and efficiency.
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EU-Based Quality & Consistency
- Operating from the EU, we uphold the highest industry standards through rigorous multi-step review processes. This approach minimizes errors, enhances reliability, and ensures compliance, delivering consistently top-tier case processing.
- 2500 Cases processed per year
- 96% First-time approval rate
- 100% On-time completion
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Can you provide, manage, and support safety databases?
Yes, we can both set up and manage a safety database for you or work within your existing system. Our team is experienced with various pharmacovigilance platforms, including Veeva Safety Vault, Argus, and ArisG. We offer comprehensive services such as GxP validation, regulatory compliance, and support for safety data migration, ensuring secure and tailored solutions to meet your needs.
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Do you provide end-to-end case processing services?
Yes, we handle the entire case lifecycle - from case intake and triage to medical review, narrative writing, coding, and submission. Our team ensures compliance with global regulatory requirements and adapts to the complexity of innovative biotech products.
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Can you handle both clinical and post-marketing cases?
Absolutely. We support case processing for both clinical trial (SUSARs, SAEs) and post-marketing (ICSRs) safety data, ensuring appropriate handling, expedited reporting, and regulatory compliance.
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Are your case processors medically trained?
Yes, our case processing team includes medically trained professionals with strong scientific backgrounds including MDs and Pharmacists. They ensure high-quality narratives, accurate assessments, and appropriate medical terminology throughout the process.