Alliance for Clinical Research Excellence and Safety

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.

Information Systems and Technology: Since a true global system for conducting clinical research requires infrastructure and integration, from technology to networked relationships, ACRES progress in 2014 was marked by three inter-related developments: (a) Further evolution of the utility of ACRES Website, the information vehicle from which ACRES and stakeholders deliver the message for Accountable Research. This includes registering research sites in the ACRES Global Network of Sites to provide them with Ally services to support their sustainability and qualifying for Accreditation; (b) Proving and implementing the initial stage of the ACRES BlueCloud - a universal collaborative interface and delivery platform from which documents, products and services are made available to end-users, forming the basis for a unique healthcare and clinical research integration; and (c) Planning 'next generation' development of an "Optics-Purposed Information System - a technological approach enabling 'seeing' the system operations at work in real time - to integrate with (a) and (b) for generating, overseeing, and evaluating data from and among multiple stakeholders in an ethical, regulatory compliant, and efficient way. Related to these advances is mapping the dataflow of clinical research with particular attention to points of security and confidentiality, vulnerability. This project also includes two standards development, global non-profit organizations. ACRES volunteers co-authored 1 international distributed clinical research paper and presented at 4 various global conferences. ACRES professional volunteers contributed over $ 300.0 K in professional services.

Site Development and Support: The Site Accreditation and Safety Initiative (SASI) develops standards for the conduct of clinical research at the local site level as a basis for instituting a global system of accreditation of research sites, thereby ensuring inter-operability, enhancing quality and safety, while recognizing and rewarding high-performing professional sites. Leveraging ACRES work as part of the U.S. Institute of Medicine's Clinical Trial Site Accreditation Action Collaborative from 2012-2014, ACRES is now in Phase 3 of this global initiative guided by more than 60 subject matter experts throughout the world, with pilot testing of standards being available in late 2015. ACRES volunteers co-authored two clinical research papers and presented to four global conferences on the benefit of site accreditation and rewards for sites of excellence. ACRES volunteers contributed nearly $ 240.0K in professional services.

Safety and Pharmacovigilance: The Product Safety Culture Initiative (PSCI) mission is to improve the robustness of safety culture among stakeholders (research sponsors, regulators, ethics committees, among others) focusing on the key points of interaction and information exchange involving adverse events. Led by subject matter experts and additional contributors (numbering up to 30 individuals at any given time and specific sub-project), this initiative focused on two major projects: (a) applying systems engineering methods and tools used in other environments to bio-medical R&D; and, (b) integrating safety-related databases of healthcare and research; ACRES volunteers contributed nearly $160.0K in contributed professional services.

ACRES Global Challenge: Our global outreach is evidenced not only in its technology, Allies, and Foundation Initiatives, but also by the continuing progress in developing ACRES regional and country Co-Development expansion and ACRES model Global Challenge by (a) building on presentations and discussions in 2014 with representatives from over 25 countries and virtually all World Health Organization-designated regions, ACRES will convene a Regional and Country Coordination meeting in June, 2015 in Washington, DC in conjunction with the global conference of a colleague non-profit, the Drug Information Association; and (b) a public-private partnership model for countries expanding their clinical research capacities as part of their own healthcare and economic development public policy priorities, with countries interested in the Global Challenge typically being those that are emerging or re-developing (in comparison to those that are the established drivers of clinical research activity), such as Pakistan and Bangladesh, among others, whose representatives have approached ACRES. Relationships continued to be developed in 2014 for specific projects with the National Institutes of Health's CTSA network of academic medical center research sites; and the Food and Drug Administration-sponsored C-Path for global implementation of disease-specific research standards and processes.