SCRS Talks

Understanding the nuances and proper tactics for negotiating a budget with a clinical research trial pharmaceutical sponsor could be considered an art to some. We sit down with Dawn Pittinger at BioOptronics to discuss and learn where the current state of negotiating with a sponsor is in today's rapidly changing world, as well as tactics that can be employed to help assure success at the research site level. 

Recruiting clinical research patients is often times a tremendous challenge for a site. In the era of COVID-19, this problem has only grown more difficult to manage. Matt Miller, President of StudyKik discusses what these challenges are and how they are different in our current environment as well as ways to overcome those unique challenges. It is critically important to understand how recruitment is changing and what can be done to meet this situation head-on. Finding patients and assuring their safety and making the experience as convenience as possible is of utmost importance and Matt discusses how we can address this. 

For years, sites have been talking about and navigating through traditional remote site monitoring, where a Clinical Research Associate (CRA) from a Sponsor or CRO performs monitoring activities remotely, over the phone and via email to reduce trips to the site. However, in the age of decentralized trials companies have pioneered a new ways to effectively monitor sites remotely. In comes VirtualPreSite and their glasses technology, allowing remote views into the sites. We sit down with Deric Frost, VirtualPreSite's Head of Virtual Site Monitoring to discuss how this technology is changing the way trials are monitored. 

As many in the clinical research industry adopt work-from-home policies in response to the COVID-19 pandemic, it is a critical time to consider the cyber security of your work. There are people out there looking for opportunities to take advantage of the situation and are attempting to hack our computers and access business data. It is important that businesses consider cyber insurance as added protection. Hear from our partners at Hylant as they discuss what this means for you and the best steps your business can take. 

In terms of the service the site provides to the sponsor of a study, regulatory work is of utmost importance -- and many times a defining factor of service quality overall. Especially in the time of COVID, regulatory teams are burdened with figuring out how to make sure this critical work is done and done well even when everyone involved is not in the same room. But, many regulatory teams have figured out that there are issues beyond simply where people are working that are plaguing the quality of this work. So how do regulatory teams provide the highest quality especially during this time? We decided to ask an expert - Rick Arlow, founder of Complion.

Oncology trials present a unique challenge in the clinical research space, particularly when it comes to patient recruitment. The identification windows are narrow, yet participation in precision trials can have life saving options for many patients with an unfortunate diagnosis. The CEO and Co-Founder of Deep Lens, Dave Billiter talks with us about how this recruitment is such a challenge and what tools may be available to help this process as well as how communication is key to running a successful recruitment campaign. 

Decentralized clinical trials in a post COVID-19 world are undoubtedly here to stay. Recent events have had a drastic effect that is likely lasting as it relates to trials at the site levels. This can be a positive thing. Much of what sites can do now is prepare for this new future and VirTrial's Senior Vice President of Business Development, Amanda Rangel talks with us about just that. There is much to do, and now is the time to do it so that you are ready for what is coming and the future of clinical trials. 

Budgets for clinical trials are always a highly discussed topic and one that SCRS regularly addresses with our partners on behalf of sites. Catherine Click, Greenphire's director of clinical pricing and analysis talks with us about how sites can "get their ducks in a row" to better negotiate and justify their study budgets. Not only can sites be more effective in their negotiations, but we also discuss some ways to better speed the time it takes to negotiate that budget. Having the data and information to back your fees is a critical component of which this interview discusses. 

IQVIA Technologies is focused on using innovation to enable better relationships with sites. Part of this strategy is centered around remote data monitoring strategies to address reducing staffing and CRA mobility. MaryAnne Rizk, PhD with IQVIA Technologies discusses how these technologies ensure patient and staff safety amidst the current pandemic, as well as how we can all work better to keep current clinical trials on track. We also look to the future and how artificial intelligence and machine learning can begin to see their day at sites. 

Amidst these interesting times in the age of COVID-19, we know that this has already affected sites, CRO's and Sponsors.  It's not over yet and we don’t know the long-term impact from the disruption. What we do know is that all stakeholders are repositioning, trial continuity is front and center, and sites are focused on site and study sustainability through retention efforts and are quickly adopting decentralized methods. Circuit Clinical's CEO Irfan Khan sits down to discuss what patient engagement of the future will look like and how can engagement be applied to the site of tomorrow.