This presentation discusses key elements required in developing a high quality clinical investigational plan (or protocol) to collect data on a medical device.  Whether your device is a new concept or already commercialized, any new study needs to weigh the risks to the patient participants against the potential benefits the results from the study may yield.  The protocol is the roadmap defining the steps required to conduct a successful study.

Medical device trials are faced with challenges that can range from low/slow enrollment to site regulatory concerns. As with all investigational clinical trials, the success of the trial is directly related to successful sites. However, the traditional selection criteria utilized in drug trials often fail to produce high quality, high enrolling medical device sites. Here, we will discuss the selection criteria unique to successful investigational medical device sites.

Real-world data provides a new level of insights that help improve clinical trials. To harness these insights, trial sponsors must consider the quality and integrity of a host of data sources, including patient-reported outcomes. This presentation discusses approaches to capturing and evaluating patients’ self-reported data on their health conditions and quality of life. 

With the sudden, unexpected arrival of “the pandemic,” sponsors were forced to think outside the box to enroll their clinical trials. How can sites reach potential study patients with traditional office visits becoming telehealth visits?  Social media – Facebook, Instagram, LinkedIn, TicTok and Twitter – was the obvious answer. In this talk, we will explore ways a sponsor can effectively use social media to recruit study patients while remaining regulatorily compliant.

This topic will focus on how one company developed and implemented a Remote Monitoring Quality Assessment tool and process post COVID-19. The discussion will focus on the process development aspect, why the process was necessary and the determinants/components used for developing the tool. The discussion will include factors to consider when determining if there is a difference in data quality between remote monitoring and on-site monitoring.

As the medical device clinical trial market is rapidly growing, so are the opportunities to augment traditional study designs with virtual trial sites and DCT solutions. However, there are a number of misconceptions about online patient recruitment, enrollment, and participation. In this session, we bust six of these “virtual site myths” using first-hand data from a gastroenterology digital therapeutics trial. 

In many organizations specialized roles and teams to facilitate Risk-based Quality Management are created. I will summarize 10 years of my experience in creation, recruitment, and development of CM/RbQM teams. I will share examples of recruitment process tasks and cases aiming to confirm the desired skills and we will look at an exercise aiming to "brake" the simplest trial ever designed.

One benefit to come from the pandemic is the way in which it forced us to embrace technology more, be open to new ways of operating and meaningfully make advances to bring clinical trials to the patients. During this session I will share with you how, during the pandemic, we implemented decentralized/virtual trial components into our studies and how it is helping us also have more diverse study populations.

Remote monitoring in clinical trials has been an acceptable standard for several years now, but with the onset of the COVID-19 pandemic, the need to remotely monitor clinical data has become a necessity. When remote monitoring isn't a familiarity within your organization, how do you devise the appropriate steps to move forward? This talk will discuss steps taken to efficiently create a remote monitoring plan for your team.

This presentation will review applicable regulatory guidelines for monitoring of clinical trials in state of emergency, data integrity/quality expectations; provide an overview of FDA's remote inspections findings and review trends; share best practices for remote monitoring and alignment of policies/procedures between stakeholders, and provide insights into contracts/budgets amendments for remote versus on site monitoring.