Pharmacovigilance is the science and practice of monitoring, assessing, and reporting the safety and efficacy of medicinal products, especially during clinical trials. Pharmacovigilance aims to prevent, detect, and manage the adverse events, serious adverse events, and adverse drug reactions that may occur due to the use of the products, as well as to ensure the benefit-risk balance of the products. Landmark CRO offers the following pharmacovigilance services:
Safety Data Collection And Management
Safety Data Analysis And Evaluation
Safety Data Reporting And Communication
Safety Data Collection And Management
Landmark CRO collects and manages the safety data from various sources, such as the case report forms, the electronic data capture systems, the spontaneous reports, the literature, and the social media. Landmark CRO uses validated software and databases to ensure the quality, integrity, and security of the safety data, as well as compliance with the data standards and regulations.
Safety Data Analysis And Evaluation
Landmark CRO analyzes and evaluates the safety data using various methods, such as signal detection, causality assessment, risk assessment, and benefit-risk assessment. Landmark CRO also performs periodic safety update reports (PSURs), aggregate reports, and safety signal management, to identify and monitor the safety trends, issues, and risks of the products, as well as to recommend and implement the appropriate risk management measures and actions.
Safety Data Reporting And Communication
Landmark CRO reports and communicates the safety data to the relevant stakeholders, such as the sponsors, the investigators, the ethics committees, the regulatory authorities, and the public. Landmark CRO prepares and submits the required safety documents, such as the individual case safety reports (ICSRs), the expedited reports, the safety narratives, the safety summaries, and the risk management plans (RMPs). Landmark CRO also ensures the timeliness, accuracy, and completeness of the safety reporting and communication, as well as compliance with the reporting and communication guidelines and requirements.
