IVD Sponsors and CROs are tasked with identifying new processes and systems to facilitate clinical trial monitoring and management remotely due to COVID-19 restrictions.
This requires developing and implementing plans to continue subject enrollment, sample collection and testing, efficient data collection and monitoring without the benefit of in-person, on-site review. The use of technology and innovation are critical to perform these clinical study tasks remotely and keep projects on track. During this webinar, Beaufort will review a case study that details the required planning and implementation of best practices to conduct monitoring visits remotely, including:
- Factors in the Sponsor/CRO Assessments/Decision-making processes:
- Which sites are equipped to participate in monitoring visits performed remotely?
- Which types of visits can be performed remotely and related key considerations?
- What technologies & processes can be used to remotely review source documents & site binder documents?
- How to effectively communicate with the Principal Investigator and site staff without being on site?
- Required updates to study documentation
- Risks and Mitigations
- Application of lessons learned to future clinical trials
This webinar was recorded on November 3, 2020 in collaboration with Q1 Productions. Beaufort presenters were:
- Trish Landry, MBA, RAC, CCRP, Senior Vice President, Clinical Operations
- Leah Hollins, MPH, BA, Senior Clinical Project Manager