Contact
SCRS Communications
Society for Clinical Research Sites
410.696.5080
communications@myscrs.org
FOR IMMEDIATE RELEASE
SCRS Reschedules 2022 Global Oncology Site
Solutions Summit
Hanover, MD, January 13, 2021 – The Society for Clinical Research Sites (SCRS) has announced it will be rescheduling the 2022 Global Oncology Site Solutions Summit, originally planned for January 28-29, 2022 in Austin, Texas. The event will now be held May 21-22, 2022.
“After thoughtful and extensive discussion with SCRS leadership
and our partners in the clinical research industry, SCRS has decided to
postpone the event to May 2022,” said SCRS Chief Operating Officer Allyson
Small. “The recent surge in Covid cases has impacted travel approvals for
many of our attendees. In addition, we understand the importance of
prioritizing the health and safety of the patients our oncology sites service.
For these reasons we believe it is in the best interest to move the meeting and
give time for the surge to dissipate as we have seen it do in other regions of
the world.”
The fourth annual Global Oncology Site Solutions
Summit aims to increase efficiencies and improve
site sustainability among clinical research sites participating in oncology
studies. The program will explore topics such as diversity, pediatric
drug development, privacy and data, medical device regulation, decentralized
trials, wearables, and digital readiness for oncology-specific trials and care.
”While last year’s Global Oncology Summit was held successfully
in a virtual environment, we know that the live gathering of sites and partners
is preferred,” continued Small. “The
push to May gives us additional opportunity to add more program components and
develop an even more robust agenda for our membership.”
Registration for the 2022 Global Oncology Site Solutions Summit is open now. Learn more at https://oncologysitesolutionssummit.com/
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About The Society for Clinical Research Sites Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/ .
In November, we reconvened for Sites NOW to discuss the 2021 SCRS Global Site Solutions Summit and some of the highlights from popular sessions. Lindsey Morales of Labcorp Drug Development, Ana Marquez of Clinical Site Partners, and Karin Gulbrandsen of Janssen joined us to share lessons learned and hot topics of discussion in each session. It’s Not You, It’s Me: How to Manage Long Term Partnerships As the pipeline of clinical trial work evolves and changes over time, the importance of quality relationships between sites and sponsors and CROs will increase. Sponsors and CROs will engage sites that align with current and mid-term projected opportunities and remaining in contact over the long-term will become even more important. Attendees gained insight into navigating clinical trial evolution to position their sites for success. Chris Hoyle of Elite Research Network facilitated the session with panelists Silvina Baudino of Teckro, Lindsey Morales of Labcorp Drug Development, Robyn Schmidtke of Merck. Fundamentally, this session focused on communication. As we know, partnerships of any type are all about communicating with and learning about one another. But, what does it mean to communicate? What does it mean to be honest and build trust with one another? Sites, speak up! Sponsors and CROs want sites to share information and challenges because “if they don’t know about it, they can’t help you with it.” Keep conversations going about training as the industry looks for solutions to minimize the amount of training needed for new technologies and reduce overall technology burden for sites. Be open and candid and transparent about the things we’re learning with each other. One popular point of discussion sites shared was that CRO databases seem to be places where information just goes into a black hole. Industry is incorporating site feedback and working on better databases to keep everything in one place and reduce redundancies, so please continue providing feedback. We also shared how crucial it is for our industry to attend meetings and conferences to take communication to a new level by putting a face to a name and building a personal connection. Industry conferences, virtual meetings, site advocacy or focus groups, and community forums are a great place to foster relationships and provide value to one another throughout the year. Continue reaching out to sponsors and CROs to find people you can partner with and who will be an advocate for your site. They want to know you and help you as much as they can, so don’t be afraid to ask for assistance or contacts if needed. Hybrid Decentralized Trials: Critical Considerations It’s no secret that digital innovations are here to stay, especially in the form of decentralized trials. While there are important considerations to be made from an administrative and process perspective, it is equally critical that we consider how patients will be affected. This session discussed how decentralized trials affect patient interaction so we can ensure patients’ needs are addressed. Facilitated by Todd Albin of Cedar Health Research, panelists included Deena Bernstein of Datacubed Health, Nicole Latimer of Medrio, Scott Connor of Signant Health, and Karin Gulbrandsen of Janssen. Understandably, sites remain concerned about building and maintaining patient relationships when using DCTs. However, the intent of decentralized clinical trials (DCTs) is to engage patients where they are and increase retention. Many opportunities remain to build relationships with trial subjects in different ways and may be nourished through a combination of phone calls, video calls, texts, and in-person visits. Sites are also apprehensive about PI oversight specific to DCTs due to lack of understanding of regulations. PIs still need to make sure they are delivering quality expected from in-person visits, while industry needs to provide guidance for investigators as they navigate these new expectations. It was also shared that sponsors and CROs need better understanding of financial liabilities for sites regarding implementation of new technology. Sites expressed that budgets are often poor with DCTs, yet add a lot of work for the site. Additionally, many digital platforms ask for specs, then other sponsors or studies ask the same information again. Communicating these challenges can help industry to create a uniform way for sites to provide technical authentication pieces in the future. It’s important to remember that adding new technologies to trials is not one-and-done; as we implement different elements, we need to continue to get the feedback on what’s working and what’s not. It’s an ongoing learning process that will only be successful if sites and industry work together to find solutions that benefit all. FDA Audits: Yes, That Really Happened! FDA audits are an inevitable reality that all sites should be prepared for before they are audited. This session included perspectives from those who have experienced FDA inspections to share how they prepared for the audit and what measures they have implemented to ensure future inspection-readiness. Ana Marquez of Clinical Research Partners facilitated the session with panelists Shivani Shah of DM Clinical Research, David Vulcano of HCA Healthcare, Rick Arlow of Complion, and Lisa Kodis of Illingsworth Research Group. This session discussed recent FDA audit need changes and what the FDA is looking for, such as informed consent issues and delegation log issues. How do sites prepare for audits? Panelists noted that it is critical to prepare site staff by discussing specific steps to take after being notified of an audit. Sites should identify a key team for inspection and minimize involvement of too many people as much as possible. One option may be to hire an expert to assist you with the process, especially if you have been issued a 483. Investing in the proper individual to guide you through it can make it a much easier process for your site. It’s also important to note that sites can set limits in their contracts when it comes to FDA inspections regarding communications protocols, such as only notifying the sponsors whose trials will be affected by an audit. SCRS will continue to host workshops, webinars, and provide resources for sites to self-monitor and be as prepared as possible for FDA inspection. FDA also offers an audit manual online that industry can pull which shares every question to anticipate the auditor asking. The meeting then separated into breakout sessions to discuss takeaways from these sessions and the 2021 Global Site Solutions Summit. We hope you will join us for the next Site Solutions Summit and encourage you to get your tickets as early as possible to secure the lowest rate! For the full November 2021 Sites NOW discussion, watch the Sites NOW meeting recording here.
Contact: Marissa Hill Communications Manager Society for Clinical Research Sites communications@myscrs.org 410.696.5080 x150 FOR IMMEDIATE RELEASE Teckro Joins SCRS as Global Impact Partner Hanover, MD, January 19, 2022 – Today, the Society for Clinical Research Sites (SCRS) announced a Global Impact Partnership with Teckro, a clinical trial hub for consistent collaboration between sites and sponsors. As a Global Impact Partner (GIP), Teckro will align with sponsors, CROs, and service providers dedicated to promoting high-level communication and meaningful partnerships between industry stakeholders and clinical research sites globally. With this collaboration, Teckro will help SCRS set and pursue strategic initiatives and directly work with clinical trial sites and industry peers to address challenges of clinical trials. “At Teckro we believe that clinical trials, which are often the best possible care for many diseases, must be more accessible to people everywhere. It is the sites and trusted physicians, nurses and other staff who are the heart of clinical research and champion for patients. That’s why we are pleased to partner with SCRS to support this active, vibrant community and to participate in initiatives that will help reduce the burden on sites so they are equipped to manage safer, faster and more efficient clinical trials,” said Gary Hughes, Teckro CEO and co-founder. Sean Soth, Senior VP of Strategy and Global Business Partnerships for SCRS, commented, “Active communication is a critical factor for site success. Teckro is working to make communication among stakeholders easier, providing sites with relevant guidance when they are with patients. As digital innovation continues to evolve for site personnel, tools and ideas for improved communication will make collaboration easier. SCRS is pleased to recognize Teckro’s involvement in the Global Impact Partner program and looks forward to including their contributions and ideas for sites and industry in 2022 and beyond.” Learn more about the partnership in the SCRS Talks podcast interview with Silvina Baudino, Director, Site Engagement at Teckro. ### About TeckroRecognized as one of the fastest growing software companies in the clinical trial market, Teckro transforms the study protocol into a hub of communication and collaboration. It’s a digital platform that connects all study stakeholders with the knowledge they need, when they need it. Thousands of investigators and more than 27,000 sites around the world rely on Teckro to execute clinical trials. Teckro works with emerging biotech and global pharmaceutical organizations, including 12 out of the Top 20 companies. The Teckro cloud-based platform supports all therapeutic areas, all phases, and any trial format ranging from traditional in-clinic, decentralized clinical trials, or a hybrid approach. About The Society for Clinical Research Sites Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.
