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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).
The contract negotiation process is generally believed to be the primary bottleneck in site startup. 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.
“Facilitating study start-up is essential to improving the clinical trials process. Every day of delay is a very costly impediment to the development and availability of new medicines. MAGI demonstrates the power of bringing together the stakeholders to collaboratively build effective solutions benefitting everyone. ACRES strongly supports MAGI’s CTA template and applauds MAGI’s desire to join forces with any and all similar initiatives,” said Greg Koski, ACRES Co-founder and CEO.
In addition to creating its 11-page CTA template, MAGI has educated thousands of industry professionals about CTAs and certified hundreds of them as Clinical Research Contract Professionals (CRCP).
“Real estate lawyers can negotiate $30-million-dollar 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 endeavor and accelerate medicines development. Despite a decade of various disruptive, innovative or transformative efforts, serious challenges remain. ACRES believes that 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.
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.
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
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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.