End-to-End Case Management

Qinecsa is a leading global provider of end-to-end pharmacovigilance solutions.

Seamless End-to-End Pharmacovigilance Solutions

At Qinecsa, we understand that effective case management forms the backbone of pharmacovigilance operations. Our end-to-end case management solutions provide companies with robust, compliant, and efficient processes for handling adverse event reports from intake through to submission to regulatory authorities.

Our case management services begin with comprehensive intake processing across multiple channels. Whether adverse events arrive via email, telephone, digital platforms, or literature sources, our team ensures each report is captured accurately and promptly. We also implement validated workflows to standardise the intake process, ensuring no critical information is missed and all regulatory timelines are noted.

Expert Medical Professionals

Our team of qualified medical professionals conducts thorough medical review and causality assessment for each case. With expertise spanning diverse therapeutic areas, our reviewers evaluate case information within its proper clinical context. This ensures, and strengthens, the quality of your safety database and enhances the value of the following signal detection activities.

With Qinecsa’s end-to-end approach, our team carries out the preparation and submission of cases to regulatory authorities worldwide. We maintain current knowledge of submission requirements across global markets to make sure your reports meet region-specific formats and timelines. Our submission tracking systems also provide complete visibility into reporting status, which supports audit readiness and regulatory compliance.

Manage High Volumes of Safety Reports Efficiently

Standardized workflows enabled by automation tools to streamline processes and increase efficiencies.

Standardize Global Data

Centralized solution to process data from multiple intake formats, resulting in a highly compliant output.

Generate Meaningful Safety Insights, Faster

Best-in-class technology and people to increase availability of well-coded data and drive faster, more meaningful signal management.

Quality Control and Continuous Improvement

Quality is at the heart of our case management process. We carry out multi-layered quality control checks, regular audits, and performance metrics to maintain the highest standards. Our continuous improvement also identifies opportunities for process enhancement, thus keeping your pharmacovigilance operations efficient and compliant with evolving regulatory expectations.

Value Added Case Management Solutions

Digitally Enabled Intake

Facilitate digital and analogue intake across multiple channels through a unified solution that drives standardization and compliance.

Accurate and Compliant Reporting

Timely reporting of outbound ICSRs meeting the highest standards of regulatory expectations along with efficient compilation of aggregate reports.

Enhanced Case Processing

Leverage technology to standardize safety reports and reduce errors, enabling pharmacovigilance experts to focus effort where it matters most.

Expert Medical Review

Expert assessment focused on the individual cases that matter most, enabling targeted follow-up and rapid downstream signal detection.

High Caliber Pharmacovigilance Experts Leveraging Best-in-Class Technology to Conduct Highly Efficient Case Management

Working with Qinecsa for Your Needs

We pride ourselves on transparent communication throughout the case management process. With Qinecsa managing your case processing activities, you can redirect internal resources toward strategic pharmacovigilance initiatives while maintaining confidence in the quality and compliance of your foundational safety operations.