Case Management
Pharmacovigilance Solutions with Qinecsa
Our comprehensive case management services are the foundation for effective drug safety solutions and compliance outcomes. We expertly handle individual case safety reports (ICSRs) from intake through to regulatory submission. From start to finish, our experienced team ensures accuracy, timeliness, and compliance at every step.
Minimising risk and maximising patient safety is a top priority for us, which is why our case management solutions feature a streamlined process from data migration and medical reviews to follow-up and reporting. Qinecsa is here to support your intentions while maintaining the highest standards in global safety monitoring.
We offer scalable, compliant, and robust pharmacovigilance services designed to meet the evolving needs of our clients.
Our advanced team of pharmacovigilance experts bring deep regulatory knowledge and industry insights to every engagement, ensuring that our clients remain compliant in a rapidly shifting landscape. Whether you’re navigating complex safety regulations or managing increasing case volumes, our services are both flexible and reliable.
Sustained, Consistent, and High-Quality Delivery
With a dedication to delivering high-quality and consistent results, our team understands how to navigate regulatory requirements, client challenges, and the ever-changing nature of the pharmacovigilance field. Our commitment to excellence focuses on tailored, responsive services that align with the goals or safety requirements of our clients and partners.
Service Flexibility and Scale
Qinecsa’s services are designed with flexibility in mind. We personalise our approach to meet your unique needs, from rapidly responding to project demands to managing routine case processing or diverse challenges. As a leading pharmacovigilance company, our work with long-term clients is built on trust and fostering collaborative partnerships.
Cost Effective Services
Our cost-effective approach is supported by solid infrastructure and standardised processes that maximise efficiency without sacrificing quality. With advanced tools and technology, our specialists monitor workflows closely while helping clients optimise their resources. Through thoughtful planning and execution, Qinecsa offers industry-leading pharmacovigilance solutions at a value you can rely on.
End-to-End Case Management Services
Developed to simplify and enhance your processes, you can expect regulatory compliance at every step—from initial ICSR management and literature screenings to expert medical reviews, seamless data migration, and timely submissions. With a focus on accuracy, efficiency, and quality, Qinecsa offers extensive end-to-end case management services, so you can focus on offering premium clinical and commercial products for patients worldwide.
ICSR Management
Effective management of individual case safety reports (ICSRs) is the cornerstone of a robust pharmacovigilance system. At Qinecsa, we deliver end-to-end ICSR management with specialised services and advanced technology to ensure the highest level of safety and compliance.
Our comprehensive suite of ICSR management services spans the entire process, from initial intake and triage to data entry, quality checks, and medical reviews. Each step is crafted to facilitate expedited submissions and exchange ICSRs efficiently with business partners, leading to reduced turnaround times and improving the safety of your products.
Case Intake
Adverse event data is systematically collected from various sources, including spontaneous reports, literature, and regulatory partners. Each event is rigorously triaged to assess urgency, severity, and seriousness, along with ensuring swift and appropriate action.
Review
Healthcare professionals conduct meticulous data entry and review processes. This includes MedDRA coding, WHO drug coding, and narrative writing, plus evaluations of seriousness and causality. Follow-up queries are also managed to ensure complete and accurate reporting.
Reporting
Regulatory submissions and partner exchanges are managed to meet global compliance standards. Whether it’s drugs, biologics, vaccines, medical devices, or advanced therapy medicinal products (ATMPs), data is reported accurately and on time, contributing to the overall safety profile of client therapies.
Literature Screening & Review
At Qinecsa, our pharmacovigilance literature screenings and review services help identify individual case safety reports (ICSRs) and detect potential safety signals that are critical for regulatory compliance. Our comprehensive process supports case processing, aggregate report inclusion, and the evaluation of emerging safety concerns through the signal management process.
Our multidisciplinary team takes a thorough and customised path for literature searches, using strategies to meet your specific criteria. From the initial search string design to the final evaluation, we prioritise precision and relevance with databases like Embase and PubMed.
Search Strategy
We develop bespoke search strategies covering both ICSR identification and safety surveillance aspects. Each search is efficiently crafted to align with your clients’ therapies.
Screening and Review
Our professionals conduct an initial screening to filter relevant abstracts and exclude irrelevant material. Afterwards, full texts are carefully reviewed based on predetermined eligibility criteria.
Full Texts and Translations
We provide end-to-end services that include full text procurement, detailed assessments, and translations. Our skilled reviewers also generate comprehensive reference summaries with relevant sources and citations for future use.
Submissions
Our team at Qinecsa ensures seamless and timely ICSR submissions worldwide, whether electronically or manually. We also handle all submission formats so your regulatory obligations and business partner agreements are met with 100% compliance. Rest assured, our data migration services preserve the integrity and performance of your data through a smooth, and worry-free transition.
Expedited Reporting
Our dedicated regulatory team addresses the accuracy and completeness of every ICSR submission. Before submitting, we verify that each package has undergone a client review and meets regulatory standards. Submissions are managed through Gateways, health authority web portals, eFax, emails, and postal services.
Business Partner Distributions
Qinecsa understands the importance of maintaining compliance with safety data exchange agreements (SDEA). Our pharmacovigilance specialists timely distribute ICSR packages to relevant parties using Gateway and emails, while prioritising consistency in every submission.
Reconciliations
Regular reconciliations with partners are performed, based on SDEAs, to measure compliance. Qinecsa tracks regulatory and partner compliance metrics, and reports back periodically to provide oversight and confidence in meeting your requirements.
Data Migration
Our data migration services provide a secure and unified transfer of ICSR data from one safety database to another. This complex process involves consolidating everything in one location in order to protect data and optimise performance. Our meticulous approach minimises disruptions and allows you to focus on what matters most — patient health and safety.
Secure Data Transfer
With Qinecsa’s data migration solutions, you benefit from the expertise of seasoned pharmacovigilance professionals. We’re committed to delivering secure, high-quality, and optimised services throughout the entire migration process.
Flexible Services
Our services are flexible and adaptable to meet your changing needs. Whether responding to urgent challenges or scaling to accommodate future growth, Qinecsa ensures your data stays protected and accessible.
Cost-Effective Solutions
High performance and efficiency is important to our team, but so is creating peace of mind for our clients. Our approach to data migration is cost-effective and supported by advanced technology, resulting in enhanced workflows and long-term client satisfaction.
Medical Review of ICSRs
We prioritise the safety and efficacy of our clients’ therapies through expert medical reviews of ICSRs. Qinecsa’s team of seasoned specialists perform in-depth evaluations so each case is analysed for accurate safety assessments. This contributes to the highest standard of pharmacovigilance and ultimately leads to the improved well-being for patients.
Coding
Adverse event data is systematically collected from various sources, including spontaneous reports, literature, and regulatory partners. Each event is rigorously triaged to assess urgency, severity, and seriousness, along with ensuring swift and appropriate action.
Causality
The medical review process involves a deep dive into patient demographics, medical history, and concomitant medications to determine the potential causality between adverse events and suspect treatments. This detailed analysis provides critical insights into the relationship between the drug and any observed outcomes.
Pharmacovigilance Comments
Qinecsa’s professionals synthesise all available case data to provide structured, SOP-driven pharmacovigilance comments. These comments summarise the causality conclusions for each event, supported by a robust rationale, and guides future decision-making.
Read Our Case Study
Discover how we supported our client’s case processing activities during the COVID pandemic.
