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Remote Monitoring and How to Save Cost
May 26, 2021 @ 9:00 am - 10:00 am$10 – $25
May 26th, 2021
1 hour educational credit
Risk-based monitoring including remote monitoring, is an approach that has been successfully applied now for many years. With increased requirements for conducting post-market clinical follow-up studies and registries, how can monitoring be optimized so you continue to ensure compliance and accuracy of data that will be accepted by the notified bodies or regulators while keeping costs reasonable?
Risk-based remote monitoring combined or not with onsite activities and a strong risk management structure, along with well-designed compliant tools can make the whole process much faster and reduce the amount of financial and human resources needed.
Moreover, with the current restrictions implemented to contain the global COVID 19 pandemic, remote monitoring may well be the only solution to avoid a complete halt in research!
Here are a few important points that are worth considering:
- Optimize time spent on source document verification, device accountability and other monitoring tasks – use the previously required travel time to effectively monitor instead of travelling and save the travel costs.
- Work closely with hospital staff from the start of the study to establish which remote monitoring tools are feasible for the different monitoring tasks.
- Plan process wisely – i.e., more flexibility working on the different monitoring tasks remotely versus trying to do it all in one day while onsite.
- Target objective(s) of the PMCF – focusing on what you really need to know will reduce the costs along with moving as much as possible to remote monitoring.
- Among the many other practical tips that will be presented throughout the webinar, remote monitoring also contributes to safeguarding our planet – i.e., electronic documents vs paper and less travel!
Ms. Danielle Giroud
Founder, CEO MD-Clinicals
With over 30 years of experience within the medical device industry, Ms. Danielle Giroud is founder of MD-Clinicals ( https://www.md-clinicals.com), a purely medical device-focused CRO with offices in Switzerland, Frankfurt, and Beijing.
Ms. Giroud is regarded as an internationally recognized clinical research and regulatory expert, having shared her extensive knowledge and experience with hundreds of multi-national companies, organizations, and start-ups from around the globe to help bring their products to market quickly and efficiently.
She is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization ( https://www.wmdo.org ), as well as convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155, and liaison with the EU Commission – Clinical Investigation and Evaluation (CIE) task force and other regulatory authorities throughout the world.
Piet Lesage, Principal Consultant, GB5D, LLC.
- OCRA Members: $25
- Non-Members: $100, includes 1-year OCRA membership
- Government and Student Members: $10, with student/government ID
- Non-Member Government and Student Rate: $45, includes 1-year OCRA members
OCRA Registration Instructions:
It is important that you register with the name and email address where you want the webinar information sent and with the name you want to appear on the certificate of attendance. Certificates of attendance will be emailed within a day of the event.
Registration deadline is May 25th. There is no same-day registration.
OCRA’s non-profit Federal Tax ID# 33-0630455
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