SCRS Talks is a platform for sites to hear about valuable information from our Partners in a quick, interview format. Our partners have important updates that SCRS knows you would love to hear about. These short interviews will provide insight into key industry topics, current events, new perspectives, and exciting opportunities.
If you are a GIP and have interest in submitting a proposal to offer an SCRS Talks interview, use the link to the form below.
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Clinical Trial Innovation
“Innovation” is a term often used to describe many things, particularly in the clinical research space. Our industry’s need for meaningful innovation has never been more apparent than it is right now. We sit down with Craig Lipset, the Managing Partner of Clinical Innovation Partners and Assistant Professor of Health Informatics at Rutgers University to discuss what innovation looks like and how this has changed as a result of our pandemic. As A teaser to his keynote presentation at the 2020 Global Site Solutions Summit, Craig will also highlight some of the key points he will address at his talk.
Negotiating with Sponsors
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.
Subject Recruitment Challenges in the COVID-19 Era
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.
Remote Access to Research Sites - Virtual Site Monitoring
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.
Cyber Security in the Age of a Pandemic
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.
Keys to Quality in Regulatory Work, Even During a Pandemic
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.
Recruiting Precision Oncology Trials
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 Trials in a Post COVID-19 World
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.
The Problems with Clinical Trial Budgeting: Get your Ducks in a Row
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.
The Power of Remote Site Monitoring and Data Review
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.
Every Trial is in Rescue - Engagement is the Key to Future Success
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.
Connecting Patients, Sites, and Sponsors to Improve Clinical Trials
COVID-19 has highlighted a need for patients, sites, and sponsors to work together more effectively and remotely. Yet, efforts to do so are often limited by systems and processes that limit data sharing and collaboration. We’re sitting down with Bree Burks from Veeva Systems to discuss new opportunities to address this challenge by making it easier for study partners to work together across the full clinical trial life cycle. From their unique prospective, we explore some of the unique challenges the industry is facing and where there are opportunities for the future.
Virtual Monitoring - Shifts and Changes in the Face of COVID-19
We sat down with Lauren Litzinger at Pfizer to discuss virtual monitoring of clinical research sites and studies. We are seeing a shift in how monitoring is being conducted in the wake of COVID-19 and the requirement for so many activities to go virtual and digital. Monitoring is no exception. Various options for data verification and review are discussed, as well as what are some of the changes being seen at the pharmaceutical sponsor level.
Deploying Digital Technologies to Boost Support to Sites During COVID-19
IQVIA Technologies has focused on three important areas for deploying technology to support sites. Melissa Easy from IQVIA discusses with us how technology is affecting sites, sponsors, and CROs and how their approach to technology is changing the relationship. The focus has to be on how technology can make the lives of sites easier, and addressing the concerns sites have specifically around payments and finances. Having one place to direct sites in order to help navigate virtual challenges and technology is one such specific solution proposed by IQVIA.
The Patient's Voice - A Clinical Trials Day and Melanoma Month Special Feature from two Melanoma Survivors
In this special Clinical Trials Day and Melanoma Month feature, hear from two Melanoma survivors as they discuss the insurmountable odds faced by their diagnosis and subsequent illness. The challenges they faced with not only the initial treatment, but also those experienced by the clinical trial process. Both T.J. Sharpe and David Aizer share their unique perspectives on their journey’s and the different paths that they took that shared some astounding similarities. Yet with all of this adversity they faced, they maintained a positive attitude and outlook, refusing to let their conditions get the best of them. These survivors help us in the clinical research industry maintain intention and focus as we work to safely speed the execution of clinical trials because we know that patients are waiting for the medicines of tomorrow.
Virtualization of Clinical Trials
With the immediate and pressing need for sites to incorporate virtual elements, we talked with Anthony Costello at Medidata on what is being done in the industry to support the new way of performing clinical trials. Discussion centers around unified platforms and how these types of solutions can be beneficial for not only sites and patients, but the entire industry. There are several advantages of unifying services and tools at the site level and we discuss what some of those may look like.
The Ever Growing Environment of Virtual Trials
Clinical trials are moving towards trends of using more and more technology, even before COVID-19. This trend doesn’t mean the role of the site has diminished, but just changed. What tools do sites need to help them succeed? How can flexible payment systems, direct-to-patient services, and telemedicine platforms enable site success? Greenphire’s Zach Hales discusses the different ways in which we need to start thinking to support patients where they are – in the clinic, the lab or in their home. Using technology to move research sites forward is critical to the growth of our industry.
Sponsors are Transitioning to Direct-to-Patient Trials – Are you Prepared?
In an effort to ensure clinical trial continuity in the midst of COVID-19, more and more sponsors are moving towards Direct-to-Patient models to ensure patient access to medications. In order for sites to adequately prepare for this new approach, it is imperative to understand current trends and challenges as sponsors are approaching these models differently depending on their study and supply chain considerations.
The Future of Risk Management for Sites
The Covid-19 pandemic caught everyone by surprise. Now that some time has passed and we are acclimating to the current climate, what should sites be thinking about when it comes to risk management and insurance?
This is not just an insurance discussion – it’s a discussion about risk. This includes the increased use of telemedicine and prevalence of decentralized clinical trials. This final interview with Hylant will help sites make important decisions regarding these matters
Site Participation in Decentralized Clinical Trials
It pays to be prepared, especially in uncertain times. As sites struggle to maintain patient visits and keep trials moving forward amidst COVID-19, many are turning to remote monitoring and other elements of decentralized clinical trials (DCTs) to ensure their doors stay open. This SCRS Talks interview with Global Impact Partner (GIP) VirTrial provides insight into how sites can prepare to participate in DCTs or incorporate virtual visits into their trials. Listen in as VirTrial’s Director of Business Development, Emil Hoeck, discusses industry trends related to COVID-19, identifies best practices for going virtual to support your site’s sustainability, and addresses why now is the time to become virtual trial capable.
Keeping the Doors Open: An Interview with Hylant
The COVID-19 pandemic is a serious situation requiring careful navigation, and many companies associated with clinical trials are struggling to keep their doors open. How am I going to survive the next few months? What questions do I need to be asking? Who can I rely on for accurate information and guidance? Learn from Hylant as they sit down with SCRS to discuss how this is impacting sites, specifically their insurance policies.