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 startup 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,” said Greg Koski, ACRES co-founder and CEO.
In addition to creating its 11-page CTA template, MAGI has certified hundreds of industry professionals 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,” said 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.