AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 14, 2024

A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection. All three medications […]

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XTalks

DECEMBER 10, 2024

The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinical trials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinical trials.

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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Bio Pharma Dive

AUGUST 29, 2022

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 19, 2024

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

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Velocity Clinical Research

JANUARY 30, 2025

Velocity Clinical Research, the leading multi-specialty clinical research 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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 29, 2024

The Union health ministry has issued final notification defining the clinical research 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 […]

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XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

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ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. Yet, the opportunity extends beyond simply increasing profitability.

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Worldwide Clinical Trials

APRIL 8, 2025

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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 25, 2024

The recent regulatory developments to relax clinical trial norms in India are poised to have a significant impact on the pharmaceutical industry and drug pricing. By easing regulations, Indian pharma could see a reduction in the costs associated with human studies.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

Researchers analyzed the electronic health records of more than 18,000 US patients between May 2022 and September 2023 to compare outcomes among those receiving the two injected medicines, and published the […]

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XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7

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Rethinking Clinical Trials

JANUARY 15, 2025

Lindsell is professor and cochief of biostatistics and bioinformatics, director of data science and biostatistics at the Duke Clinical Research Institute, and director of biostatistics and bioinformatics at the Duke Clinical and Translational Science Instituteall at Duke University. Join the online meeting.

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Rethinking Clinical Trials

NOVEMBER 4, 2024

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.

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Bio Pharma Dive

OCTOBER 14, 2024

Learn how the right NGS technology can enhance clinical research while supporting downstream efforts toward global commercialization.

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Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research 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.

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Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research 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.

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Imperical Blog

APRIL 10, 2025

Changes taking place in the United States and internationally may affect the clinical trials landscape in the months and even years to come. … The post Keeping Clinical Trials on Track: Navigating Supply Chains, Tariffs, and Regulatory Shifts. appeared first on Imperial Clinical Research Services Blog. .…

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Advarra

MARCH 7, 2025

Clinical research 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. It is the foundation of medical innovation.

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ACRP blog

JANUARY 14, 2025

Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct, and reporting within the global ecosystem. A key question is what kind of behavior changes can help us improve as clinical research professionals? To succeed, we must overcome our fears.

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Velocity Clinical Research

MARCH 23, 2025

Clinical trials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2%

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Clinical Trials Clinical Trials Trials Life Science 52

ACRP blog

OCTOBER 30, 2024

enrollment of women in medical schools had just climbed to 20%, it is notable that the chronicles of the Association of Clinical Research Professionals (ACRP) describe the first meeting of two nurses who were among the field’s earliest clinical research coordinators, Sarah Boyer and Anne LeSher, as the impetus for the formation of the Association.

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XTalks

MARCH 12, 2025

Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinical research, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinical research.

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XTalks

APRIL 17, 2025

Their discussion shows how meaningful partnerships, deep listening and unwavering patient-centricity can transform clinical research, trial design and care delivery in rare conditions such as HPP. Early collaborations in clinical trial design enabled both teams to integrate critical patient insights into study protocols.

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Clinical Research Research Clinical Trials Clinical Trials 52

Worldwide Clinical Trials

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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My Local Study

APRIL 21, 2025

In the fast-paced world of clinical research, securing and retaining engaged participants is paramount to the success of any study. Think of it as an “engagement window” Read more The post The Engagement Window: Why Speed is Key to Retaining Clinical Trial Leads appeared first on MyLocalStudy.com.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

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.

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Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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ACRP blog

MARCH 18, 2025

says David Vulcano, LCSW, MBA, CIP, RAC, FACRP , Vice President, Clinical Research Compliance and Integrity, at HCA Healthcare and author of a recent ACRP White Paper on Responsible Oversight of Artificial Intelligence for Clinical Research Professionals. in April.

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Rethinking Clinical Trials

MARCH 28, 2024

Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. View the Equitable Language Cheat Sheet.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 30, 2023

Four patients with severe chemical burns to one eye have shown early positive results in a phase 1 clinical trial of a therapy based on their own stem cells.

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Clinical Trials Clinical Trials Trials Research 245

FDA Law Blog

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. Below, we explore some of the key themes seen in the changes.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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