Magi Clinical Trial Agreement

This article was reprinted in Volume 21, Issue 19 of CWWeekly, a leading clinical research industry newsletter that provides advanced analysis of the latest news, study results, study results and more. Subscribe ” MAGI is part of the growing list of nearly 200 organizations and individuals who partner with ACRES and each other around the world to improve the safety, quality, transparency and cost-effectiveness of clinical research and accelerate drug development. Despite a decade of disruptive, innovative or transformative efforts, serious challenges remain. ACRES believes that progress has been limited by the lack of seamless connection and integration of these efforts. ACRES works to overcome these constraints by proposing an interconnected, integrated, transparent, multi-party, collaborative approach to the system, and welcomes MAGI`s thoughtful and inclusive approach and innovative solutions. “Facilitating the launch of studies is essential to improving the clinical study process. Every day of delay is a very costly obstacle to the development and availability of new drugs. MAGI demonstrates the strength to bring stakeholders together to develop effective solutions that benefit everyone,” said Greg Koski, co-founder and CEO of ACRES. CWWeekly presents this function twice as a light on topics that confront executives in clinical research. This week, writer Suz Redfearn spoke with Norman Goldfarb, President of Model Agreements – Guidelines International (MAGI), an organization that has been promoting the standardization of clinical trial agreements (ATCs) and contract models for a decade that can use both websites, CROs and sponsors to accelerate the start-up.

Goldfarb is also Editor-in-Chief of the Journal of Clinical Research Best Practices and Managing Director of First Clinical Research. In April, the Association of Clinical Research Professionals Goldfarb presented the Innovation Award for the MAGI CTA initiative. MAGI provides models that, in a clinical study contract, are largely acceptable to all parties – sponsors, sites and CROs, which generally negotiate agreements. The MAGI treaty is supposed to be neutral. In the world of drugs, I can imagine a situation where a producer makes a CRO as a sponsor and CTA would be between the site and the CRO. A compromise clause is: “This agreement is concluded by and between the sponsor and the investigative site. The lead investigator proceeds as an employee of the institution and not as a party to this agreement.┬áThe lead investigator is then asked to sign the agreement to justify his understanding and intent. [N] Signatories Industry sponsors sometimes do not recognize the employee-employer relationship between investigators and investigative sites and suggest that the investigator sign the CTA.