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says David Vulcano, LCSW, MBA, CIP, RAC, FACRP , Vice President, ClinicalResearch Compliance and Integrity, at HCA Healthcare and author of a recent ACRP White Paper on Responsible Oversight of Artificial Intelligence for ClinicalResearch Professionals. in April.
enrollment of women in medical schools had just climbed to 20%, it is notable that the chronicles of the Association of ClinicalResearch Professionals (ACRP) describe the first meeting of two nurses who were among the field’s earliest clinicalresearch coordinators, Sarah Boyer and Anne LeSher, as the impetus for the formation of the Association.
Change management is an overarching theme in innovation, with a need to mitigate and resolve barriers to change due to low institutional and personal risk tolerance, says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, at the FDA Center for Drug Evaluation and Research (CDER).
This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinicalresearch, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinicalresearch.
Click here Research + Font Resize – ICMR to hold workshop on measuring oxidative stress in pre-clinical mouse models to boost […] Home Editorial Services Interview Q&A Chronicle Specials Pharma Mart ePharmail Archives Join Pharma | Login Home > TopNews you can get e-magazine links on WhatsApp.
In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinicalresearch. Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.
She celebrates how healthcare professionals have an exceptional power to transform lives, and will share her perspective on how compassionate care can be incorporated into clinicalresearch in a Signature Series keynote session tailored for attendees of ACRP 2025 in New Orleans, La., in April. View complete schedule. We feel radiant.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinicalresearch? This new guidance will clearly impact the clinicalresearch field, but how? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development?
If theres one thing clinicalresearchers can count on when it comes to regulations and guidance from governing bodies, its change. The Academy agenda covers: Human research protections U.S. Learn more about HCCA The post Keeping Up with the ClinicalResearch Compliance Landscape appeared first on ACRP.
The Union health ministry has issued final notification defining the clinicalresearch organisations (CROs) and mandating registration for the organisations to operate under the New Drugs and Clinical Trials Rules (NDCTR), 2019. The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September […]
Planning on running clinical trials in Japan? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. How can you reliably supply these studies?
Experts are here to demystify the clinical trial process, with Dr. Frances Broyles and Dr. Sheryl Marks of Rainier ClinicalResearch Center offering valuable insights to help you make an informed decision about participating in this critical step toward advancing healthcare.
Decentralized clinical trials (DCTs) bring many benefits to the clinicalresearch process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.
Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke ClinicalResearch Institute, and director of biostatistics and bioinformatics at the Duke Clinical and Translational Science Instituteall at Duke University. Join the online meeting.
Clinicalresearch has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.
2024 has been a year of growth and evolution in clinicalresearch. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinicalresearch, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
The convergence of gene therapies and clinicalresearch is pushing the boundaries of what’s possible in ophthalmic care, offering hope for more effective treatments and potential cures for a range of vision-threatening conditions.
In clinicalresearch, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products. These collaborations align research goals with community needs and regulatory expectations.
The post November 4, 2024: Update to Living Textbook Offers Tips for Developing a Compelling PCORI Grant Application appeared first on Rethinking Clinical Trials.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
The clinicalresearch industry plays a vital role in advancing medical knowledge and improving healthcare; however, the increasing complexity of clinical trials has created a perfect storm of challenges for clinicalresearch sites, posing significant risks to the efficiency, effectiveness, and sustainability of clinical trials at large.
The adoption of the ICH E6(R3) Guideline for Good Clinical Practice marks a defining moment in the evolution of clinical trial execution. As someone committed to advancing quality and innovation in clinicalresearch, I see this milestone as an opportunity for our field to grow and adapt in meaningful ways.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Velocity ClinicalResearch, the leading multi-specialty clinicalresearch organization, has partnered with Verified Clinical Trials (VCT) to set a new benchmark for patient safety and data quality in clinical trials through a new technological implementation at Velocitys 80+ global sites.
Paul Evans sat down with Patricia Leuchten on the Leaders & Legends podcast, where they discussed the state of research sites and the broader industry. Listen now to hear Paul’s thoughts on: The evolution of clinicalresearch sites and whats ahead for the industry.
Expanding Velocitys Fully Integrated Site Network in Europe Velocitys European network currently comprises 17 wholly owned clinicalresearch sites, each staffed with experienced principal investigators (PIs) and research teams specializing in a wide range of therapeutic areas. This isnt about imposing a U.S.
The benefits of diversity and inclusion in clinicalresearch are widely recognized, yet the financial and operational costs of these efforts are often overlooked. The Hidden Costs of Diversity and Inclusion in ClinicalResearch Join MaryAnn and Mitchell at ACRP 2025 [April 24-27 ; New Orleans, La. ]
XTALKS WEBINAR: Generative AI in ClinicalResearch: From Data to Patient Cohorts Live and On-Demand: Wednesday, December 11, 2024, at 1pm EST (10am PST) Register for this free webinar to learn how generative AI is revolutionizing clinicalresearch from streamlining data abstraction to building more precise patient cohorts.
At Medpace, Advanced Clinical Practitioners (ACPs) are essential in bridging clinicalresearch with patient-centered care, enhancing the effectiveness, ethical standards and overall participant experience in obesity trials ( Figure 1 ). This helps minimize confusion and frustration for participants, reducing the risk of dropout.
A healthy relationship between sites and sponsors is critical to the success of clinical trials, including efficient and effective management, adaptability, innovation, problem-solving, and feedback mechanisms on the parts of those involved on both sides.
We know that the demand at the site level for studies is growing and the workforce capacity is shrinking, notes Bree Burks, RN, MSN, Vice President of Strategy for Veeva Systems, who will present on The ClinicalResearch Technology Reboot: Are We Getting it Right? The ClinicalResearch Technology Reboot: Are We Getting it Right?
This collaborative spirit can lead to developing novel methodologies and strategies for monitoring and evaluating clinical trials, ultimately advancing the field of clinicalresearch. This strategy is indispensable for advancing the clinicalresearch field and ultimately improving patient outcomes across the globe.
People who are entering the clinicalresearch profession can come from many other fields and with very diverse backgrounds. Project management requires leadership, communication, and management skills that can be applied in any role across clinicalresearch.
Implications for Future of ClinicalResearch R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.
As the world’s first humanised IgG4-κ monoclonal antibody targeting IL-17RB, SM17 has made satisfactory progress in clinicalresearch under the active promotion of the company.
Youve probably heard it all before: The clinicalresearch enterprise has a problem with expecting new hires in what are often basically low-paying, entry-level positions to already have two or more years of experience with the positions duties. next April. next April.
The cheat sheet includes preferred terminology when referring to the following identities: Age Race and ethnicity Gender Differing abilities Drug/substance abuse People who are underserved, at increased risk, or economically marginalized Partners and populations of focus The Health Equity Core provides direction for pragmatic trials on how to integrate (..)
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