ACRO

Leaders from the #ClinicalTrial landscape are turning to artificial intelligence 🤖 to close "the gap between administering quality health care and conducting critical medical research," reports Newsweek. At a recent industry panel, ACRO Board member and Oracle Health and Life Sciences Executive Vice President and General Manager Seema Verma spoke about how AI technology can ease burdens for both providers and patients. 🗣🗣🗣 "When we talk to some of the academic research institutions, they say, 'We don't have the capacity to do any more [clinical trials]. We don't have enough nurses. We don't have enough doctors. We don't have enough people to do more clinical trials,'" says Verma. "And so if we can automate some of this work, there's a capacity to do even more clinical trials and make it easier, so that it doesn't just have to happen at an academic research center..." Read more about her thoughts on how #AI can alleviate these burdens and open doors to improved research, then tell us: What do you see for the path of AI in clinical trials? https://lnkd.in/gKVFR2B2

The clinical research industry and the regulatory agencies that support it are continuing to navigate the complex challenges, and tremendous opportunities, that AI introduces to the landscape. Last week, in its response to a White House Office of Science and Technology Policy (OSTP) RFI, ACRO urged the FDA to finalize draft guidance on Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making. We were pleased to see this draft guidance embrace a risk-based ⚠️, flexible 🤸, and pragmatic 🧠approach to AI oversight which enables AI deployment, adoption, and innovation. ACRO echoes the position presented in the OSTP RFI — The full benefits of AI cannot be realized through complete de-regulation. To contribute to this critical conversation, we've shared our comments on the draft. 💭 One key thought from our letter: Guidance documents are a key element in fostering an agile approach to drug development, including the deployment of AI, and provide a stable, predictable business environment. Find our complete letter here: https://lnkd.in/gJKDC8fu

At the NC Life Sciences Organization annual meeting, ACRO's own Sophia McLeod joined Taking the Pulse - A Health Care and Life Sciences Podcast to share how ACRO works with Congress and the FDA to shape the future of clinical trials. The🔐key: "It's a relationship game." 🤝Build relationships by checking in not only when you have an ask. Share your work! 🧠Educating policymakers and regulators to demystify complex issues is essential. Listen in:

In the face of industry complexities, increasing costs, and pushes for speed, it's important that #LifeSciences consultancies and CROs stay focused on clients, explains ICON plc. Technical expertise is not enough for an organization to reach its goals of developing meaningful treatments and serving its patient populations. It's important that teams put patients first, develop structured feedback programs to assess performance, and be open to adjusting programming to meet these aims. The group shared a few tips for CROs that are moving toward a more client-centered practice: 🧭 Understand the dynamic evolving between regulatory bodies and #ClinicalTrial organizations. Advocate in ways that help clients navigate these regulatory landscapes with confidence and anticipate potential difficulties. 🤝 Build trust with regulators by demonstrating transparency, preparedness, and compliance with requirements. 🤔 Hold a partnership mindset to transform service delivery through deeper collaboration, accelerated problem-solving, and enhanced ability. 👑 Be authoritative in recommendations, honest in assessments, and committed to long-term success. 🤳 Stay on top of the digital transformations, AI-driven insights, and reshaped global marketplaces. Consider how these shifts are restructuring the life sciences landscape. Focusing on clients is not simply a trend. It's a transformation that has and must come to the industry. Read more about how consultants and CROs can follow this shift and center their work on client missions and better outcomes. https://lnkd.in/gzMqsiz4

Last week, Sophia McLeod of ACRO, along with representatives from many ACRO member companies, gathered at Research Revolution powered by Florence Healthcare to explore how CROs, sites, sponsors, innovators, and regulators can better facilitate connectivity and drive innovation. The opening discussion between Robert Califf, former FDA Commissioner and Instructor of Medicine at Duke University, and ACRO Board member Catherine Gregor, Chief Clinical Trial Officer at Florence, set the tone for the conference, balancing the industry's achievements with the many challenges that lie ahead. Sophia joined in a breakout session focused on the current state of the industry and, essentially, how we can actively engage in delivering necessary change. At the forefront of this and every session, the question: How do we move forward better? Read the full recap: https://lnkd.in/g8xeST_9 #ResearchRevolution #ClinicalResearch #ClinicalTrials #Innovation #Leadership #FlorenceHealthcare

Representation doesn’t grow in 📊spreadsheets — it grows in communities, through 👥people. This is the driving mission behind ACRO's Site Resource Grants Program. In a new Clinical Leader article, Chief Editor Dan Schell highlights how the grant program is helping a retired family physician, now working as a clinical researcher with Preferred Clinical Research, improve access to clinical research through 🤝community engagement, 💡education, and 🌐relationship building between community members and healthcare providers. To shift diversity efforts at sites from 💬buzzwords to 💰budgets, you have to ask the right questions and engage the right people — communities. Read the full article: https://lnkd.in/gqkTvMuH

What makes a clinical trial management system (CTMS) so crucial to a clinical trial's success? A CTMS is a centralized command center for clinical operations, explains Medidata Solutions. A good one protects against trial delays, compliance risks, and budget overruns. It streamlines workflows, enhances data accuracy, and ensures compliance with global regulatory standards. All of these benefits and protections are key drivers of effective research. Not all platforms provide the same advantages, though. The best CTMS supports seamless integration, which will encourage: 📈 real-time data flow between processes that will guide better decision-making; 📁 automated document workflows and milestone tracking to decrease operational burdens; and ✔️ audit readiness and reporting. Learn more about the power of an effective CTMS, then tell us: what do you think a stronger CTMS could do for your team? https://lnkd.in/g-c3HJVq

National Cancer Awareness Month reminds us of both the extraordinary progress and the unfinished work in oncology. Alicia C. Staley, Chief Patient Officer at Medidata Solutions, reflects on a simple truth in a new blog: the future of cancer research depends on how well we listen to patients and each other. Focusing on the power of empathy to drive better research, Alicia unpacks the value of patient centricity, the importance of data sharing, and the criticality of trust, particularly in oncology. She lays out three priorities to guide the next generation of cancer research: 🗣️ Embed Patient Voice Early and Often. Patient insights can refine endpoints, reduce burden, and improve retention. 👥 Make Patient Centricity Cross-Functional. Integrate patient engagement into every layer of the research enterprise. 💪 Strengthen the Ecosystem That Enables Innovation. Advocate for continued investment in science infrastructure and a well-resourced FDA that supports evidence-based regulation. Read on to learn how we can build an ecosystem where patients are not participants but partners ➡️ https://lnkd.in/gNaPrzi5

During #HealthLiteracyMonth, the clinical research industry has an opportunity to emphasize the important role trial participant comprehension plays in ensuring meaningful health outcomes, sustained engagement, and fair representation. With the increasing use of technologies like 🤳🏻eCOAs, 📝eConsent, 📲Telemedicine, and ⌚wearables, health literacy now requires digital literacy, explains Pamela Tenaerts, MD, MBA, Chief Medical Officer at Medable, Inc. How can you improve patient comprehension and satisfaction? Pamela walks us through data from a recent study exploring the impact of leveraging interactive elements such as ▶️videos, 📆e-calendars, and 🧠real-time comprehension checks, on patient experience and, even trial representation.  🚧 Sponsors and CROs should bear in mind: Regulatory guidances have elevated digital literacy and access as persistent priorities in trial design and execution. Read more, and tell us: How is your organization ensuring digital literacy among clinical trial participants? https://lnkd.in/gAtFjx6B

When it comes to cancer, "efficiency in oncology drug development is not optional — it is a necessity." For National Cancer Awareness Month, Dr. Daniel Mazzolenis, SVP in Medical Management at Syneos Health, argues that the pursuit of efficiency in oncology trials is not a trade-off against quality or safety but rather a way to ensure sustainable progress. And CROs have a pivotal role to play in enabling efficiency without compromising scientific or ethical standards. He lays out several strategies that are already reshaping the efficiency landscape: 1️⃣ Streamlined Biosimilar Development 2️⃣ Flexible Trial Designs 3️⃣ Fair Reimbursement and Patient Support 4️⃣ Risk-Based Monitoring and Data Privacy 5️⃣ Inclusive Trial Design Read on to learn how we can reduce inefficiency and drive innovation in oncology trials ➡️ https://lnkd.in/gmvXuKJp