ProRelix Research

FEBRUARY 12, 2023

Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused […] The post Clinical Trial Regulations in the United States appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Regulation Trials 105

Cloudbyz

APRIL 17, 2024

Decentralized clinical trial (DCT) platforms represent a paradigm shift in the way clinical research is conducted. By leveraging technology, DCTs aim to make clinical trials more accessible and convenient for patients, reduce costs and increase efficiency.

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Clinical Trials Clinical Trials Trials Compliance 89

pharmaphorum

AUGUST 25, 2023

Mapping the landscape of clinical trial regulation Mike.Smith Fri, 25/08/2023 - 10:00 Bookmark this

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Clinical Trials Clinical Trials Regulation Trials 97

Drug Discovery World

MARCH 23, 2023

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. For example, the regulatory and ethics reviews of clinical trial applications will be integrated.

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Clinical Trials Clinical Trials Regulation Trials 93

Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials.

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Clinical Trials Clinical Trials Trials Regulation 62

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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Clinical Trials Clinical Trials Trials Drugs 154

STAT News

SEPTEMBER 26, 2022

Regulators in half a dozen European countries are now taking steps to enforce requirements that clinical trial sponsors make study results public, although three other countries have so far taken little to no action, a new analysis finds. Continue to STAT+ to read the full story…

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Clinical Trials Clinical Trials Regulation Trials 119

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2023

The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)

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Clinical Trials Clinical Trials Trials Drugs 132

Drug Discovery World

OCTOBER 16, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”

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Clinical Trials Clinical Trials Regulation Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 2, 2024

With a focus on equipping regulators with advanced skills, the CDSCO conducted 23 residential training programmes tailored to address critical aspects such as […]

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Regulation Drugs Clinical Trials Clinical Trials 148

Imperical Blog

JANUARY 9, 2024

Diversity in clinical trials is becoming mandatory, which can make drugs and devices more widely beneficial. New FDA regulations are coming; read on for our understanding of what to expect.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Pharmaceutical Technology

APRIL 20, 2023

The face of clinical research is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Everybody got used to doing things remotely.

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Clinical Trials Clinical Trials Trials Nurses 130

XTalks

JANUARY 17, 2024

Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

ACRP blog

MARCH 12, 2024

Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. When time is of the essence, how do you scale trials internationally for success? This is a sponsored message.

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Clinical Trials Clinical Trials Trials Regulation 59

Bio Pharma Dive

MAY 17, 2023

The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.

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Clinical Trials Clinical Trials Regulation Trials 255

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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Clinical Trials Clinical Trials Trials Clinical Research 98

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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Clinical Trials Clinical Trials Regulation Clinical Research 312

STAT News

MARCH 22, 2023

Medicines and Healthcare products Regulatory Agency announced sweeping changes to regulations governing clinical trials , Pharmaphorum explains. Among the changes will be a facility to run regulatory and ethics reviews of clinical trial applications in parallel and to reduce the time it takes to get a study up and running.

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Clinical Trials Clinical Trials Regulation Trials 98

Worldwide Clinical Trials

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Clinical Trials Compliance 185

BioPharma Reporter

FEBRUARY 28, 2022

The new clinical trials regulation makes it easier to conduct clinical trials in the EU, according to an EU Commission representative.

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Clinical Trials Clinical Trials Trials Regulation 111

BioPharma Reporter

MAY 9, 2024

The Asia-Pacific (APAC) region is leading the way in the asthma clinical trials space, conducting the most studies globally between 2019-2023, with China, India, and South Korea among the top countries, GlobalData reveals.

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Clinical Trials Clinical Trials Trials Regulation 52

XTalks

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Regulatory Considerations.

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Clinical Trials Clinical Trials Trials Regulation 97

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 182

pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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Clinical Trials Clinical Trials Trials Regulation 126

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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Clinical Trials Clinical Trials Trials Regulation 100

ProRelix Research

AUGUST 3, 2023

Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […] The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Drugs 97

Clairnes

DECEMBER 17, 2021

The post Clinical trials: 2021 Recap and take-aways for 2022 and ahead. From Vaccine trials, new regulations, decentralized trials and patient-centricity appeared first on Clinical Trial Recruitment & Management Services.

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Clinical Trials Clinical Trials Regulation Trials 72

BioPharma Reporter

JANUARY 18, 2024

The Cell and Gene Therapy Catapult (CGT Catapult), an independent organization specialising in the advancement of cell and gene therapies, has revealed that the UK has remained an attractive destination for commercial trials, with this type of clinical trial accounting for 81% of trials in 2023 and 80% in 2022.

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Clinical Trials Clinical Trials Gene Therapy Trials 105

Cloudbyz

MARCH 24, 2023

As virtual clinical trials have found popularity, some sponsors and researchers have been hesitant to embrace it wholeheartedly. The COVID-19 pandemic has proven to be a universal disruptor in the traditional clinical trial model, and the bio-pharmaceutical industry has been forced to find new and innovative approaches.

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Clinical Trials Clinical Trials Trials Regulation 84

Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., Endpoint adjudication committees (EACs), also called clinical event committees (CECs), receive potentially identifiable research data from all over the world.

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Regulation Clinical Trials Clinical Trials Trials 52

pharmaphorum

MARCH 2, 2021

Clinical trial software facilitates clinical trials from conception to finish. For example protocol management, CRF design , metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. The aim is to get quality clinical products to the market faster.

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Clinical Trials Clinical Trials Trials Compliance 116

Rethinking Clinical Trials

APRIL 6, 2023

The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The post April 6, 2023: New Chapter of Living Textbook Describes the Ethical Considerations of Sharing Data From Embedded Pragmatic Clinical Trials appeared first on Rethinking Clinical Trials.

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Clinical Trials Clinical Trials Trials Regulation 100

Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

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Clinical Trials Clinical Trials Trials Drugs 70

Cloudbyz

DECEMBER 15, 2023

Veterinary clinical trials and human clinical trials share some similarities, but there are key differences owing to the distinct nature of the subjects involved—animals versus humans. Human Trials: Aim to assess the safety and efficacy of treatments, drugs, or medical devices for human health.

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Clinical Trials Clinical Trials Trials Medicine 64

Outsourcing Pharma

DECEMBER 21, 2023

Decentralized clinical trials (DCTs) are gaining increasing interest as they have the potential to make clinical trial operations quicker, more efficient and more accessible to patients. Check out five DCT organizations that have raised big venture capital investments in the last few years.

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Clinical Trials Clinical Trials Trials Regulation 81

Cloudbyz

APRIL 27, 2023

Regulatory automation in clinical trial operations has the potential to dramatically improve the efficiency, accuracy, and compliance of clinical trials, leading to faster development and approval of new therapies. These can range from automating routine tasks to supporting more complex decision-making processes.

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Clinical Trials Clinical Trials Trials Compliance 78

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2023

The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.

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Trials Clinical Trials Clinical Trials Drugs 152