Signal & Risk Management
Pharmacovigilance Risk Management Solutions with Qinecsa
At Qinecsa, our services and team of specialists are here to proactively identify, assess, and mitigate potential safety risks. By closely monitoring safety signals and evaluating benefit-risk profiles, we offer expert support to promptly address emerging concerns, and effectively implement risk management strategies.
Our knowledgeable professionals leverage data-driven insights and regulatory expertise to safeguard patient health while overseeing compliance with global pharmacovigilance standards. As your trusted partner dedicated to minimising risks, Qinecsa is here to enhance the safety profile of your products.
With diverse therapeutic expertise at Qinecsa, our team delivers essential safety data analysis to maintain global compliance and data accuracy.
Our multidisciplinary professionals, including epidemiologists, clinical physicians, and biostatisticians, are uniquely equipped to interpret complex data and provide thorough safety assessments. This level of expertise allows us to amplify the accuracy of our client’s safety profiles, while ensuring that your products meet the highest standards in any market.
Increase Safety Profile Accuracy
Work with our expert team of qualified physicians to interpret data that aligns with the complexities of safety assessments. By understanding data and monitoring individual case safety reports (ICSRs) and medical literature, we provide precise evaluations that improve the accuracy of safety profiles. This process is critical to making informed decisions about potential risks and ultimately protects patient health while supporting the therapeutic value of the product.
Limit Regulatory Review Cycles
Service Flexibility
Whether your company is managing an evolving safety system or a mature pharmacovigilance framework, we understand that each client has different needs. At Qinecsa, we offer adaptable service models designed to support any stage of the safety lifecycle. Whether you need full support or targeted expertise, our flexible approach provides monitoring systems that are optimised to fit specific operational requirements and regulatory demands.
End-to-End Signal and Risk Management Services
At Qinecsa, our End-to-End Signal and Risk Management Services services include comprehensive solutions for managing the entire lifecycle of drug safety cases. From signal detection and benefit risk management, to expert drug safety physician services and regulatory responses, we focus on every aspect of pharmacovigilance with precision and expertise. Our integrated approach not only helps identify, assess, and mitigate potential risks but also ensures compliance with global regulations. Our team is here each step of the way to support and guide you towards making informed decisions that prioritise patient safety and maintain the therapeutic benefit of the products.
Signal Detection & Management
Part of what we do, as a leading pharmacovigilance provider, is to take a proactive approach to identify and manage unknown risks while advancing drug safety solutions.
This robust approach contributes to optimal performance, regulatory compliance, and enhanced patient safety while ensuring products’ safety information in the global market remain accurate and reliable.
Our proactive approach includes:
- Ensuring patient well-being by monitoring individual case safety reports (ICSRs).
- Utilising a combination of advanced analysis and technology to recognize potential signals or adverse events (AE) early and for further exploration.
- Using qualitative and quantitative methods to assess, prioritise, and validate the hypotheses from collected signals for effective grading.
- Managing the signal detection processes from start to finish with a safety management plan developed by our trusted and dedicated team of specialists.
Benefit Risk Management
Our comprehensive benefit risk management services at Qinecsa prioritise regulatory compliance and patient well-being, while guiding clients through the complexities of healthcare decision-making and improving successful outcomes.
Our end-to-end benefit risk management services help clients navigate regulatory requirements while ensuring therapies meet the highest safety standards.
Our comprehensive services include:
- Safeguarding patient safety by ensuring that the benefits of a medication continue to outweigh its risks.
- Assessing therapy safety across the lifecycles through cross-functional collaboration between pharmacovigilance and regulatory teams.
- Developing risk management plans (RMP) by outlining a therapy’s current safety and efficacy profile, providing vital information on plans, and recommending and designing risk minimization measures to prevent risks and measuring their effectiveness periodically.
- Implementing Risk Evaluation and Mitigation Strategies (REMS), a safety program required by the US FDA for therapies that pose higher risks, to ensure that safety protocols are in place to address and mitigate these risks effectively.
Drug Safety Physician Services
Qinecsa offers expert drug safety physician services, ensuring extensive pharmacovigilance support throughout a therapy’s lifecycle. With a focus on regulatory compliance and medication safety, our physicians help ensure that therapies meet the highest standards.
By collaborating with Qinecsa, you can rely on the expertise and diligence of our drug safety physicians to safeguard the lifecycle of your therapies.
Our extensive support services include:
- Having physicians who are experienced in pharmacovigilance and managing the benefit-risk profile of various medicines and medical products.
- Providing well-written and comprehensive analysis reports such as in-depth case reviews, aggregate safety reporting, safety evaluations, and other benefit-risk assessments.
- Maintaining a deep understanding of the evolving global regulatory and risk management landscape and offering customised solutions for drug safety needs.
- Staying up-to-date on changes in pharmacovigilance regulations in order to achieve fast and accurate responses to regulatory authorities’ inquiries regarding drug safety and efficacy.
Regulatory Responses and Communications
In the ever-changing world of pharmacovigilance, effective regulatory responses and communications are critical for the safety of therapies and compliance with global health authorities. At Qinecsa, we navigate the regulatory landscapes and help our clients respond to safety-related requests from authorities and communicate urgent information.
By partnering with our professionals at Qinecsa, we help our clients deliver efficient, compliant solutions that keep therapies in line with evolving safety standards.
Our regulatory communications include:
- Supporting clients with the preparation and submission of regulatory communications (e.g., emerging safety concerns, aggregate reports, updated risk management plans, and revisions to labelling documents).
- Providing expert guidance for compliance issues and efficient management of regulatory inquiries.
- Assisting in the evaluation of additional data, such as individual case safety reports and medical literature, to provide a strategic and timely response.
