iQure provides cost-effective and comprehensive global pharmacovigilance solutions through regulatory compliance, higher productivity and strategic drug safety monitoring for developmental and marketed compounds.
Pharmacovigilance
Case Management
iQure model provides sponsors with expertise in prompt and adequate analysis of safety information from clinical trials and subsequent report as a SUSAR (Suspected Unexpected Serious Adverse Reaction). iQure team consisting of expert safety physicians, pharmacists and health care professionals, provides solutions for case management with accurate and detailed case narratives, medical coding and medical review by iQure experts.
Signal detection and management
iQure model provides sponsors with expertise in evidence-based risk identification. Early identification of risks is key during clinical development and our experts play key role in identifying new potential risks and developing mitigation strategies to protect subjects enrolled in the study. iQure experts assist sponsors in developing structured signal detection and risk assessment processes.
Risk management plans and Risk evaluation and mitigation strategies (REMS)
European Union Pharmacovigilance Legislation has made it mandatory to have a Risk Management Plan (RMP) for every new medicinal product applying for marketing authorization in European nations. iQure Experts can assist sponsors in developing proactive approaches to better understand and optimize benefit-risk of the medication and preparation of safety sections, characterize the risk and propose risk management plans.
Risk Evaluation and Mitigation Strategies may be essential when potential risks are identified or when, the risks associated with the drug may outweigh its benefits. iQure has a broad range of experience designing, executing and managing REMS products and programs. We have designed a proven process to develop FDA-approved risk management tools, evaluation tools and methodologies, and patient and health care provider education and awareness tools. Our extensive experience in integrating REMS programs into product commercialization plans enable us to deliver solutions to our clients quickly and efficiently.
iQure understands and continually monitors regulatory, legislative and market involving product safety and benefit-risk balance. We use our comprehensive understanding of the issues to provide REMS programs that address all aspects of risk management.
Literature Surveillance Services
Information obtained from medical and scientific literature is an important source of patient safety data and can contribute enormously to the safety profile of a medicinal product. It is a regulatory requirement for the marketing authorization holder (MAH) of a medicinal product to perform regular searches of scientific literature, including any unpublished manuscripts and abstracts presented at medical or scientific conferences. iQure team can assist sponsors in developing a robust search strategy and undertake sensitivity testing to ensure criteria are appropriate for identifying relevant safety information. We can run extensive literature searches on a weekly basis using databases like Embase & PubMed and would further identify safety data to monitor during clinical development and post-marketing surveillance.
Preparation of Interim safety reports (on demand)
We prioritize our client needs in providing customized data, through conducting interim analysis and preparation of safety reports. At times the regulators may request submission of Ad hoc reports while investigating a specific safety concern associated with a therapeutic product. At iQure, we ensure timely preparation of such interim reports and critical analysis associated with safety concerns.
Preparation of aggregate reports (PBRER, PADER, DSUR, PSUR)
We prioritize our client needs in providing customized data, through conducting interim analysis and preparation of safety reports. At times the regulators may request submission of Ad hoc reports while investigating a specific safety concern associated with a therapeutic product. At iQure, we ensure timely preparation of such interim reports and critical analysis associated with safety concerns.
Conclusion drawn from the aggregate reports are legally binding. Our medical writing team has expertise in drafting aggregate reports, by assessing the line listings or CIOMS forms. Aggregate reporting regulations have recently undergone a revision across the European Union. It is only a matter of time before the revisions are accepted and mandated globally to further strengthen the signal detection system and optimize the use of resources across the pharmacovigilance network for the benefit of public health.
We help sponsors to meet regulatory requirements for aggregate reporting with the help of our closely aligned scientific writing and pharmacovigilance teams, to support aggregate reporting and safety writing for all stages of the product life cycle. We have also helped customers by having our aggregate reporting team harmonize with their case processing partner to provide quality aggregate reports.
Conclusion drawn from the aggregate reports are legally binding. Our medical writing team has expertise in drafting aggregate reports, by assessing the line listings or CIOMS forms. Aggregate reporting regulations have recently undergone a revision across the European Union. It is only a matter of time before the revisions are accepted and mandated globally to further strengthen the signal detection system and optimize the use of resources across the pharmacovigilance network for the benefit of public health.
We help sponsors to meet regulatory requirements for aggregate reporting with the help of our closely aligned scientific writing and pharmacovigilance teams, to support aggregate reporting and safety writing for all stages of the product life cycle. We have also helped customers by having our aggregate reporting team harmonize with their case processing partner to provide quality aggregate reports.
