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

AUGUST 24, 2023

An MoU […]

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 11, 2023

Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities.

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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. The future of clinical research will be shaped by those who lead the conversation.

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Worldwide Clinical Trials

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

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Pharmaceutical Technology

MARCH 23, 2023

This week, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing major changes to clinical trial regulation in the UK with expedited timelines at several stages. The MHRA hopes this new framework “will remove obstacles to innovation” and “streamline the regulation of clinical trials” amongst other things.

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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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pharmaphorum

JANUARY 25, 2021

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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XTalks

FEBRUARY 22, 2021

Clinical research is part of a growing industry that provides individuals with rewarding career options and a ladder to climb. Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. There are many professions under the clinical research umbrella.

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BioPharma Reporter

JANUARY 17, 2023

In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.

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ACRP blog

SEPTEMBER 12, 2024

ACRP reached out to experts from graduate programs in clinical research for a snapshot of how education in this field, especially at the master’s degree level, is holding up amidst rapidly evolving changes in the research enterprise itself. Some are recent undergraduates and others mid-career professionals or clinicians.

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Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 18, 2022

With less than ten days to meet the deadline mandating the registration of Assisted Reproductive Technology (ART) clinics, ART banks and Surrogacy Clinics to be eligible to conduct counselling and procedures, five more States are yet to report to the Centre on appointment of appropriate authority.

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.

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VirTrial

AUGUST 21, 2021

A telemedicine platform intended for clinical trials must provide broader functionalities to accommodate the various needs of sponsors, CROs, patients, clinicians, investigators, research site staff, and regulators, as well as meet international regulatory requirements. This post originally appeared on Signant Health.

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XTalks

SEPTEMBER 9, 2024

Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinical research. Xtalks spoke with Stacy Weil, DHI, Senior Vice President, Business Operations and Patient Centricity, Premier Research, to gain insights into incorporating DEI practices and plans in clinical research.

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FDA Law Blog

NOVEMBER 10, 2024

FY2024 Awardees & Observations For the FY2024 Orphan Products Clinical Trials Grants Program, FDA received 51 grant applications and awarded only seven new clinical trials a grant, providing more than $17.2 million to clinical researchers over the next four years to advance the development of medical products for rare diseases.

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ACRP blog

OCTOBER 19, 2022

In the turbulent waters of the clinical research workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and around the worst of the storm. “It The post How to Weather the Clinical Research Talent Recruitment Storm appeared first on ACRP.

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Pharmaceutical Commerce

AUGUST 28, 2024

The latest news for pharma industry insiders.

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Velocity Clinical Research

DECEMBER 30, 2024

A new Fierce Biotech article features insights from Paul Evans on what to expect for clinical research in 2025. Topics include rising costs and uncertain regulations, as well as the continued emergence of site networks, AI-driven efficiency (with technology built by trial sites, for trial sites), and enhanced diversity initiatives.

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pharmaphorum

MAY 28, 2024

Navigating the ethical landscape of clinical research with minors: exploring the HHS and FDA regulations around parental permission, child assent, and adolescent autonomy under CFR 46. Learn how to ethically and legally involve young participants in studies.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 16, 2023

In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 7, 2024

A study suggests eating later in the day can directly impact our biological weight regulation in three key ways: through the number of calories that we burn; our hunger levels; and the way our bodies store fat. link] With obesity now affecting hundreds of millions of people worldwide, this is a valuable insight into how […]

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 8, 2023

The new regulations, which were first announced in May, are a world first. Each cigarette sold in Canada will have to come with an individual health warning that “cigarettes cause impotence” and cancer, and that there is “poison in every puff” under new rules that came into effect Tuesday.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 26, 2022

The National Medical Commission (NMC), the apex medical education regulatory body, has come out with draft Establishment of Medical College Regulations, (Amendment), 2022 ushering changes in rules for setting up medical institutes. According to […].

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Outsourcing Pharma

JUNE 14, 2023

In a bid to address the high demand for clinical research talent, Advanced Clinical is hosting an innovation theater at DIA Global in Bostonâs Convention and Exhibition Center.

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AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 19, 2024

Click here Policy & Regulations + Font Resize – DCA Telangana raids & seizes illegally made cough syrups in Hyderabad Peethaambaran […] 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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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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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 22, 2024

All the medical devices including in-vitro diagnostic medical devices have come under the regulation […]

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XTalks

APRIL 13, 2022

The webinar concluded with Kyle Haas, Associate Director, Clinical Trial Management, Medpace, speaking about the operational and study start-up considerations for pediatric rare disease clinical research. Aspects of Pediatric Medical Research. Challenges in Pediatric Rare Disease Clinical Trials.

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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

SEPTEMBER 12, 2024

In a significant move to enhance trade facilitation and streamline compliance with foreign trade regulations, the Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has announced amendments to the export obligation period for several import items.

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 3, 2024

The State drug regulators have reported 11 NSQs to the CDSCO […] The Central Drugs Standard Control Organisation (CDSCO) has released a list of 59 drug samples declared as Not of Standard Quality (NSQ) during the month of August, with samples of drugs labelled as manufactured by some of the major companies failing the quality test.

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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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XTalks

NOVEMBER 28, 2024

By enhancing wakefulness and regulating muscle tone, it addresses excessive daytime sleepiness and cataplexy, the disorder’s two hallmark symptoms. Narcolepsy disrupts sleep-wake regulation, leading to fragmented nighttime sleep, cognitive impairments and sudden muscle weakness triggered by strong emotions.

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