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Faber Daeufer & Itrato, in collaboration with Danforth Advisors, recently presented the first in a series of presentations about best contracting practices for the research, development and commercial activities of drug development companies. Accountability in CRO Relationships focused on the engagement of Clinical Research Organizations (CROs), and addressed general topics around managing operational risk, financial risk, unexpected changes, and post-study liability.
Tony Carita, Managing Director of Clinical Business Operations at Danforth, and Jill C. Alvarez, Principal at Faber, spoke on these topics from business and legal perspectives, respectively. Gina C. Wu,Counsel at Faber, moderated the webinar.
Danforth Advisors is a leading provider of strategic and operational services to emerging life sciences companies, including finance and accounting, HR, and clinical business operations. Carita’s team supports their clients’ business and operations teams with the establishment and management of clinical operations outsourcing.
Faber is a dynamic, diverse, independent law firm providing sophisticated, customized business counsel for life sciences clients in the US and globally. Alvarez’s team, comprised of lawyers and contracts specialists, provides a full range of clinical trial contract services, including customizing form agreements, creating and negotiating individualized clinical trial agreements, reviewing informed consent forms, negotiating CRO service agreements, and negotiating clinical trial supply and distribution agreements. Most of the individuals on this team have significant in-house experience. “We firmly believe that lawyering at its best is about counseling,” said Alvarez, “so we actively work to support and counsel our clients through our collective knowledge experience and judgment.”