AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 18, 2024

Patients taking Eli Lilly’s new drug Mounjaro achieved significantly greater weight loss than those on Novo Nordisk’s Ozempic, a head-to-head study published Monday showed.

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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 amended rules will come into force from April 1, 2025.

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Pharmaceutical Technology

APRIL 3, 2023

Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinical research for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The National Pharmaceutical Pricing Authority (NPPA) may fix the retail price of formulations which are under phase IV clinical trials based on the company’s application submitted to the central drug regulator for conducting the phase of clinical trials and other documents along with the relevant form.

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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. This, in turn, could lead to lower drug prices for patients, making medications more […]

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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. Food & Drug Administrations standard for safety and efficacy.

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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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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

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? appeared first on ACRP.

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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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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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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. Integrating AI tools into complex workflows will require time and understanding.

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Clinical Trials Clinical Trials Trials Life Science 69

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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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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Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

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Velocity Clinical Research

NOVEMBER 12, 2024

Over the past decade, Germany’s share of global clinical trial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinical research and drug development issues.

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Clinical Trials Clinical Trials Trials Clinical Research 52

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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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% Whats Causing the Outflow?

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Clinical Trials Clinical Trials Trials Life Science 52

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success. Twisted and tangled proteins are found in the brains of many of those who die with Alzheimer’s disease.

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Worldwide Clinical Trials

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. Reduces Trial Failures Oftentimes, clinical trials may fail due to a lack of efficacy.

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Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

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Rethinking Clinical Trials

AUGUST 8, 2024

Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities.

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XTalks

MARCH 26, 2025

In the fast-evolving field of clinical research, 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 clinical research: 1.

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Worldwide Clinical Trials

JULY 29, 2024

Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research. These data emphasize the need for precise and meaningful body composition endpoints in T2D and obesity clinical trials.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]

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Worldwide Clinical Trials

AUGUST 10, 2023

The Psychedelic Community Casts a Wide Net Along with a robust community of scientific researchers and medical practitioners, Psychedelic Science included artists, educators, religious and cultural leaders, philanthropists, patient and policy advocates, and many more.

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Clinical Trials Clinical Trials Trials Clinical Research 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 9, 2024

Experts in the life-sciences industry are of the view that doing away with human studies for new drugs in India is unscientific and risky as patients here have different anthropometry.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 13, 2024

The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences’ inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2024

The Central Drugs Standard Control Organisation (CDSCO) has released guidance for the companies to attain export No Objection Certificate (NOC) for manufacture of unapproved, banned or new drugs, a process which was centralised recently.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 11, 2024

(nomadsoulphotos/Canva) A Korean study published recently suggests people with type 2 diabetes who are prescribed a particular class of drug might be at a significantly lower risk of dementia.

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ACRP blog

FEBRUARY 11, 2025

If theres one thing clinical researchers 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 Clinical Research Compliance Landscape appeared first on ACRP.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 14, 2024

A Subject Expert Committee (SEC), which advices the national drug regulator on approvals and clinical trials related to Covid-19 vaccines, has recommended grant of permission to Serum Institute of India (SII) for Omicron XBB 1.5

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pharmaphorum

MAY 13, 2024

Learn how clinical researchers are embracing open data and tools to overhaul the drug development process. Think open-source is just for software? Think again.

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Clinical Trials Clinical Trials Trials Clinical Research 125

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 27, 2024

The psychedelic drug psilocybin (as found in ‘magic’ mushrooms) has promising potential as a treatment for the eating disorder anorexia nervosa, according to new research that looked at its effects on an animal model of the condition.

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 16, 2024

(Francesco Carta Fotografo/Moment/Getty Images) Migraines and headaches affect billions of people worldwide, and a new study suggests the drug ubrogepant can put a stop to the pain even before a migraine has fully kicked in.

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