Model Agreements & Guidelines International (MAGI) joins the Alliance for Clinical Research Excellence and Safety (ACRES) in working together on an effort to improve the current costly time for clinical research site study startup by bringing uniformity to the documents involved in the contract negotiation process.
The Alliance for Clinical Research Excellence and Safety (ACRES) has endorsed the standard clinical trial agreement (CTA) template created by Model Agreements & Guidelines International (MAGI), striving to break one of the primary bottlenecks in research study startup, the contract negotiation process. In 2004, MAGI initiated a collaborative effort to create a CTA template that would be widely accepted, a significant challenge given the diversity of sponsors, sites and CROs in the industry.
“ACRES is all about like-minded, systems-focused organizations and people working together and leveraging the good work being done across the clinical research landscape. Our collaboration with MAGI is a good example, capitalizing on the valuable work done by this multi-stakeholder group over the past few years to create a tool set that benefits everyone. This is critical since every day of delay is a very costly impediment to the development and availability of new medicines,” said ACRES CEO and co-founder, Greg Koski.
ACRES collaboration with MAGI is one of many bringing a collection of open-source tools to sites, CROs and sponsors to increase efficiency, promote standardization and facilitate the start-up process for clinical trials, all of which will result in significant savings in time and money while enhancing site productivity and sustainability, as well as quality. The clinical trials contracting process is challenging for all parties involved in the clinical research endeavor and a “master file” approach to establishing clinical trials agreements represents a significant advance over previous approaches. In addition to creating the 11-page CTA template, MAGI has educated industry professionals about CTAs and certified Clinical Research Contract Professionals (CRCP).
“Real estate lawyers can negotiate $30-million transactions in three hours, while we spend three months negotiating $30,000 transactions. There is now a general consensus that the time for a standard CTA template has arrived. Other model CTA initiatives have recently emerged, which we welcome as part of the process of reaching an industry-wide consensus. We can agree to save lives,” added Norman Goldfarb, MAGI Chairman.
MAGI joins the growing list of nearly 200 organizations and individuals that are teaming up with ACRES and each other worldwide on diverse collaborations to improve the safety, quality, transparency and cost-effectiveness of the clinical research undertaking and to accelerate medicines development.
Despite a decade of numerous disruptive, innovative or transformative efforts attempted by the enterprise, serious challenges remain and progress has been limited by the failure to transparently connect and integrate these efforts. ACRES is working to overcome these limitations by providing an inter-connected, integrated, transparent, multi-stakeholder collaborative systems approach, and welcomes MAGI’s thoughtful and inclusive approach and innovative solutions.
ACRES
The Alliance for Clinical Research Excellence and Safety (ACRES) is a non-profit multi-sector alliance working in the public interest. It brings together diverse stakeholders across clinical research, harnesses their expertise to collaboratively build an open, integrated global system based in principles of Accountable Research™ and adapts lessons from industries that successfully implemented principles of systems and safety engineering, such as transportation, communications and information technology. For more information, please contact Mary F. Tobin, Ph.D, Special Advisor to the President and CEO at mtobin(at)acresglobal(dot)net.
MAGI
Model Agreements & Guidelines International (MAGI) is streamlining clinical research by standardizing best practices for clinical operations, business and regulatory compliance. Our 10,000+ members represent most of the major players in the industry. Membership is free. Members obtain discounts on MAGI conference registration and free access to the MAGI CTA Template and over 150 other forms, checklists and other standards. For more information, please contact Norman M. Goldfarb, Chairman, MAGI, at ngoldfarb(at)magiworld(dot)org or 1.650.465.0119.
