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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.
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.
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.
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.
Clinicalresearch is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. The post The Value of ClinicalResearch first appeared on Advarra.
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.
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).
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?
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.
In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research. Contact us today to learn more.
In the fast-evolving field of clinicalresearch, thought leaders do more than just keep up; they lead the charge and shape the direction of the industry. Heres how thought leaders are currently making an impact in clinicalresearch: 1.
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.
Planning on running clinical trials in Japan? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. How can you reliably supply these studies?
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. The Psoriasis Diet Diet has long been an area of research as a potential factor in managing psoriasis.
Another unique challenge in psychiatry trials is the placebo response, which is notably high in mental health research. Rae emphasized the need to empower and enable research sites to accommodate patients rather than patients accommodating study schedules.
The Indian Council of Medical Research (ICMR) has announced a Request for Expressions of Interest (EoI) aimed at inviting researchers, academicians, and scientists to participate in the formulation of evidence-based guidelines for the empirical use of antibiotics in the management of sepsis, dental infections, and vaginal discharge.
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.
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 […]
The Indian Institute of Science (IISc) and Blockchain For Impact (BFI) have teamed up to maximise translational research projects where the latter aims to allocate US$1 million. The collaboration, under the BFI-Biome Virtual Network Programme, will see BFI to support various research projects at the IISc.
Aimed at driving innovation and progress in the field of microbiology, the Indian Pharmacopoeia Commission (IPC) and the CSIR-Institute of Microbial Technology (IMTech), Chandigarh, have joined forces towards advancing microbiological research and development for the betterment of public health.
The risk of Alzheimer’s disease and depression differs significantly between male and female bodies, and yet the vast majority of research on the human brain does not reflect that. Instead, male anatomy is too often considered ‘the norm’ against which all other human brains are measured.
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.
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.
Researchers see a greater need for new generation therapeutics to propel precision medicine. The current research areas of interest in India include precision medicine which treatments based on individual genetic profiles to improve […]
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.
The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH.
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.
The growing attention to phytopharmaceuticals in the Indian lifesciences landscape is an opportunity to develop potent botanical extracts, said Dr. Vidhu Aeri, Professor of Pharmacognosy & Phytochemistry and former Dean, School of Pharmaceutical Education & Research, Jamia Hamdard, New Delhi.
Clinicalresearch is a business that should focus on viable studies. Decisions can be supported using data already collected as part of the clinicalresearch enterprise. Edited by Jill Dawson The post Optimizing Research Productivity Using Data-Driven Protocol Feasibility appeared first on ACRP.
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. This distrust is further compounded by a lack of visible accountability and representation in the research process.
Independent investigators play a vital role in advancing translational “bench to bedside” research to improve human health. Setting up an investigator-initiated research program (IIRP) can encourage and support these investigators while fostering an institutions high-quality research and compliance.
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.
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.
[ Editors Note: In recognition of Rare Disease Day being observed on February 28, ACRP is pleased to present this, the second of two blogs contributed by subject matter experts offering insights on how rare diseases are being focused on by the clinicalresearch enterprise.
Technology has undeniably contributed to growing chaos at research sites. As technology becomes more embedded in clinicalresearch, transformation is essentialand possible. This is a sponsored message. Where do we go from here? Tech providers must standardize site experiences across sponsors and trials.
Collection of sensitive personal data is a cornerstone of clinicalresearch involving drugs and medical devices. Securing, anonymizing, and transferring personal data is complex and challenging in these regions, especially when there is a need to share personal data with vendors and research partners in multiple jurisdictions.
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