"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,"said ACRES CEO and co-founder, Greg Koski.
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.
The Alliance for Care & Research Excellence & Safety (ACRES) is a non-profit alliance for professionals and patients in every sector of the healthcare and life sciences enterprises. ACRES seeks to ally health and science worldwide using a systems approach. Together, we can build an effective health science system for patients everywhere.
For more information about ACRES, visit acresglobal.net.