Alliance for Clinical Research Excellence and Safety Inc.
Alliance for Clinical Research Excellence and Safety Inc.
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About this organization
Mission
The Alliance for Clinical Research Excellence and Safety, Inc. was formed to further scientific research in the public interest by improving the safety, ethics, and efficacy of human subject clinical trials. The organization intends to accomplish this goal by promoting through its various activities an integrated domestic and global network of recognized clinical research sites, a robust information technology platform, and an alliance of like-minded stakeholders, including nonprofit organizations, academic medical institutions, foundations, businesses, regulatory agencies and individuals.
About
Quality Management: Building a system for conducting clinical research globally, critically includes paying attention to Quality - the quality of the processes used to conduct research and especially the quality of the data collected and on which is based the safety and efficacy of the research. This involves the ethical ways by which the research is conducted as well as the scientific validity of the data. ACRES has two key initiatives addressing Quality, from its management to it continuous assurance (Continuous Quality Improvement). 1. Global Ethical and Regulatory Initiative (GERI) - focuses on improving the ethical conduct of clinical trials including the ethical review processes involved and regulatory issues such as vulnerable populations. A core international Steering Committee developed the project plan for the first Global Ethical Review and Regulatory Innovation Symposium Consultation, an event focusing on streamlining regulatory review in light of emerging alternative methods of conducting clinical research in an era of '-omics,' personalized medicine, and 'new science.' The first Consultation is now scheduled for March 2016, at the Petrie-Flom Center for Law and Ethics at Harvard University, Cambridge MA, using the lens of Informed Consent as an organizing theme. 2. The Quality Assurance and Safety Initiative (QASI) address issues in risk:benefit assessments, monitoring, and auditing of clinical research trials using a continuous quality management (CQI), remote data monitoring, and other tools and techniques. This initiative is focused on building into the research System, envisioned by ACRES and its Allies, quality dimensions that impact, in particular, the processes of conducting research studies where stakeholders most interact and can be dynamically (in real-time) provide performance feedback to improve those processes. In addition, QASI is examining the impact of personalized medicine trials ("trials of one") and other novel research methods from a Quality perspective. Our professional volunteers contributed over $ 475.0K in contributed professional services to acheive these goals.
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