Clinical Trial Conduct, Safety & Compliance

We advise on FDA regulatory issues that arise during clinical trial conduct, including protocol deviations, emerging safety issues, sponsor oversight obligations, inspectional observations, and FDA-facing responses to trial conduct concerns. We also provide FDA regulatory input on clinical trial, CRO, investigator, research-collaboration, licensing, and development agreements. We work alongside corporate, IP, licensing, privacy, healthcare, and contracting counsel where agreement terms affect FDA-regulated study conduct, safety reporting, inspection access, regulatory submissions, data integrity, or the use of clinical data.

We advise on:

• Protocol deviations, emerging safety issues, and GCP and GLP issues affecting development programs
• Sponsor oversight obligations and documentation, including delegation of trial-related duties to CROs and investigators
• FDA inspectional observations and responses to Form FDA 483s
• Communications with FDA on trial conduct issues, including responses to information requests and other agency inquiries during active development
• FDA regulatory provisions in clinical trial, CRO, investigator, research-collaboration, licensing, and development agreements, including provisions affecting protocol compliance, safety reporting, inspection access, records, regulatory submissions, data integrity, CRO and vendor responsibilities, and use of clinical data

Selected Experience

• Helped sponsor address emerging safety signals and an eventual clinical hold, avoiding a blanket hold across the sponsor's other clinical programs using the same technology and securing rapid lifting of the hold.
• Helped sponsor address review division concerns regarding clinical trial issues related to blinding.
• Assisted on internal investigation of protocol deviations and GCP violations during ongoing clinical trial, assessing scope and impact, developing mitigation strategy, and advising on related FDA communications.
• Successfully responded to 483s related to clinical research organization's GCP violations.