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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Clinical Research Research Clinical Trials Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 24, 2023

An MoU […]

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Regulation Production Drugs Clinical Trials 180

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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Regulation Clinical Trials Clinical Trials Clinical Research 188

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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Clinical Trials Clinical Trials Regulation Trials 147

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 Research Research Clinical Trials Clinical Trials 124

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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Clinical Research Research Clinical Trials Clinical Trials 105

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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Clinical Research Clinical Research Coordinator Research Clinical Trials 98

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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Clinical Research Research Trials Regulation 123

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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Clinical Research Research Clinical Trials Clinical Trials 110

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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Clinical Research Research Trials Clinical Trials 98

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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Regulation Clinical Trials Clinical Trials Clinical Research 189

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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Clinical Research Research Compliance Clinical Trials 98

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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Clinical Research Research Clinical Trials Clinical Trials 97

pharmaphorum

NOVEMBER 15, 2022

A renaissance in vaccines research is just one example of something good to come out of the pandemic. For the clinical trials industry, the pandemic forced new ways of working and fresh ways of thinking about clinical research and how to conduct it remotely.

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Clinical Research Research Clinical Trials Clinical Trials 105

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.

Clinical Research 101

Clinical Research Research Clinical Trials Clinical Trials 101

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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Production Clinical Development Development Regulation 69

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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Clinical Research Research Clinical Trials Clinical Trials 98

Pharmaceutical Commerce

AUGUST 28, 2024

The latest news for pharma industry insiders.

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Clinical Research Regulation Research 103

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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Clinical Trials Clinical Trials Trials Clinical Research 52

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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Clinical Research Research Regulation 69

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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Protein Scientist Regulation Research 246

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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Regulation Clinical Trials Clinical Trials Clinical Research 245

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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Clinical Trials Clinical Trials Drugs Regulation 243

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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Regulation Clinical Trials Clinical Trials Clinical Research 188

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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Clinical Research Research Regulation Marketing 88

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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Regulation Clinical Trials Clinical Trials Clinical Research 187

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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Vaccine Vaccination Clinical Trials Clinical Trials 189

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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In-Vitro Licensing Licensing Regulation 189

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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Vaccine Vaccination Clinical Trials Clinical Trials 188

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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Compliance Regulation Drugs Clinical Trials 188

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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Drugs Regulation Manufacturing Clinical Trials 187

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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Clinical Trials Clinical Trials Trials Drugs 186

pharmaphorum

DECEMBER 19, 2022

The recommendations are part of the ACT EU initiative between the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) group – launched earlier this year – intended to further develop the EU’s role as a centre for clinical research.

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Regulation Trials Clinical Trials Clinical Trials 72

FDA Law Blog

FEBRUARY 27, 2025

Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach. How regulators will interpret and enforce its provisions may not become clear for some time.

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Clinical Trials Clinical Trials Trials Clinical Research 88

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 9, 2023

The pharmaceutical industry in the country is waiting for the positive government response on the suggestions on the draft notification about the list of over-the-counter (OTC) drugs under Schedule K of Drug Rules 1945 and laid down specific provisions for its regulation in the country.

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Drugs Regulation Clinical Trials Clinical Trials 189

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

The Subject Expert Committee (SEC) for Reproductive and Urology, which advices the nation’s drug regulator on clinical studies and approvals, has recommended approval for the State-run HLL Lifecare Ltd to manufacture and market graphene condom, the next generation thinner; and stronger condom that is expected to improve the acceptability of the (..)

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Regulation Manufacturing Production Marketing 189

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 12, 2023

The Central government has notified the administrative Rules for the Committee for Control and Supervision of Experiments on Animals (CCSEA), the statutory Committee to regulate and monitor experiments on animals to prevent cruelty to animals, with provisions for deemed approval and grading of animal house facilities in medical colleges, pharmacy colleges, (..)

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