Navigating the Regulatory Maze to Enable Trial Continuity with Digital Solutions

Description

While traditionally, there has been slow uptake for technology-based solutions in clinical trials – primarily due to a lack of legal, including patient and data privacy, and regulatory frameworks – stakeholders have recognized their key suitability for supporting clinical trial continuity during the COVID-19 pandemic. In recent guidance documents many regulatory authorities have acknowledged or advocated the use of telemedicine and a range of technology solutions when necessary to support clinical trials. However, guidance from regulatory authorities varies across countries and jurisdictions, and is continuously being updated, with some authorities providing more direction than others.

Watch the webinar to learn how current and future regulatory guidance will impact digital solutions, including the full decentralization of clinical trials. The session will conclude with an open question-and-answer discussion.

Listen to this webinar where experts from PPD will guide you through:

• Evolving regulatory acceptance of innovative clinical trial applications – before, during and post COVID-19
• Regulatory developments and changing guidance on technology use to enable clinical trial continuity
• Strategies to mitigate risk and ensure regulatory compliance
• Building a case for the value of applied innovations to inform regulatory authority acceptability beyond the pandemic