Aggregate Reports
Aggregate reports represent a consolidated overview and detailed assessment of a products’ benefit-risk profile. Qinecsa provides comprehensive end-to-end aggregate reporting management, supported by our team of experts, an array of specialized services and technology.
Expert, End-to-End Aggregate Report Development
Aggregate safety reports are important components of pharmacovigilance and medical device safety monitoring activities. These comprehensive documents systematically analyse accumulating safety data to identify emerging signals, evaluate benefit-risk profiles, and ensure ongoing patient safety.
With our trusted team at Qinecsa, we specialise in developing high-quality aggregate safety reports that meet regulatory requirements and responsive submissions to regulatory authorities. Our experienced medical writing team delivers meticulously researched and scientifically robust reports.
Our approach to aggregate reporting also extends beyond regulatory compliance. We conduct a comprehensive analysis of safety information from multiple sources to find patterns and trends that may not appear in individual case assessments. With a holistic perspective, this leads to more effective safety evaluation and enhanced safety monitoring.
Scientific Interpretation and Context
At Qinecsa, our medical writers assess relevant ICSR data, literature, clinical experience, epidemiological data and regulatory recommendations to provide meaningful interpretation of safety signals. This scientific rigour ensures your reports deliver valuable insights rather than simply presenting data.
Our aggregate reports strictly adhere to current regulatory guidelines and formatting requirements from authorities including the MHRA, EMA, and FDA. We maintain vigilance regarding evolving regulatory expectations to ensure your submissions remain compliant with the latest global and local standards.
Comprehensive aggregate reporting management services, covering source data collation and review, report authoring, quality review, and medical review all designed to facilitate timely submissions to pertinent regulatory authorities.
Medical Writing Expertise
Our high caliber scientists and physicians are experienced across diverse therapeutic areas and therapy types across all phases of the drug development lifecycle.
Benefit-risk Assessment
Benefit-risk management verifies that the benefits of a medication continue to outweigh the risks, ensuring patient safety with medicinal therapies.
Submission
Qinecsa regulatory team are supported by a wide network of consultants and vendor partner network for submission readiness for global agencies including US-FDA, EMA, and MHRA.
Working with Qinecsa for Your Needs
Partnering with Qinecsa for your aggregate reporting requirements provides access to our specialist medical writing expertise and alleviates constraints within your organisation. We prioritise clear communication throughout the process, ensuring transparency in timelines, deliverables and expectations. With Qinecsa managing your reporting needs, you benefit from consistency, quality and regulatory compliance delivered by a dedicated team that understands both the science and the regulatory landscape.
