Post-marketing clinical trial services include the planning, conduct and oversight of clinical trials conducted after a medicinal product receives regulatory approval or authorization for marketing. These trials, also known as Phase IV trials or post-market studies, are designed to further evaluate the safety, efficacy, and real-world effectiveness of medical products in diverse patient populations and clinical settings.
Study Design and Protocol Development: Robust postmarketing addressing specific study objectives, endpoints, and patient populations while ensuring compliance with regulatory requirements and industry standards Collaborating with sponsors to design study protocols.
Regulatory Strategy and Applications: For post-marketing clinical trials, including Investigational New Drug applications, protocol amendments, and study registration in clinical trial registries Assisting sponsors with regulatory strategy development and preparation of regulatory submissions.
Site Selection and Management: Identifying and selecting trial sites with the necessary patient population, expertise and infrastructure to conduct post-marketing trials and continuing throughout the study life cycle Providing central management and support.
Patient Recruitment and Enrollment: Developing patient recruitment strategies and implementing recruitment campaigns to ensure timely enrollment of eligible patients in post-marketing studies, through various recruitment channels and leveraging patient engagement strategies.
Clinical Monitoring and Data Management: Overseeing the conduct of the study, ensuring protocol compliance, performing routine monitoring visits or remote monitoring to verify data accuracy and integrity, Managing data collection, processing and verification activities at the same time.
Safety Monitoring and Pharmacovigilance: To detect adverse events and safety signals throughout the post-marketing trial, including preparation of periodic safety reports and communication with regulatory authorities Implementation of safety monitoring and pharmacovigilance processes to evaluate, evaluate and manage.
Quality Assurance and Audits: Field audits to ensure compliance with protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines and to protect data integrity and patient safety and performing quality assurance activities, including data audits.
Data Analysis and Reporting: Conducting statistical analysis of study data, interpretation of study results, and clinical trial to communicate trial findings to regulatory authorities, healthcare professionals, and the scientific community preparing reports and regulatory submissions.
Health Economics and Outcomes Research (HEOR): Health economics and outcomes research to evaluate the real-world effectiveness, cost-effectiveness and economic value of medical products in clinical practice to conduct and produce evidence to inform healthcare decision-making.
Publication and Dissemination: Facilitating the publication of study results in peer-reviewed journals, presentations at scientific conferences, and dissemination of study findings to key stakeholders, contributing to scientific knowledge and informing clinical practice.
Further evaluation of the safety, efficacy and effectiveness of medical products in real-world clinical settings.
Generation of additional clinical evidence to support regulatory submissions, labeling updates and market access
Increasing sponsor and researcher satisfaction through reliable and responsive supply management services.
Clinical study device and supply management solutions offered by ALCOA ensure the seamless provision and management of clinical study materials, support the successful conduct of research studies, as well as compliance with regulatory requirements and study protocols. It is designed to maintain.
