pharmaphorum

JULY 15, 2024

Framework governing early-stage clinical trials in the UK is stifling research and needs to be simplified, says BJCP paper

Clinical Trials 107

Clinical Trials Clinical Trials Regulation Trials 107

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.

Clinical Trials 93

Clinical Trials Clinical Trials Regulation Trials 93

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 15, 2024

The Pharmacy Council of India (PCI) has framed regulations on the manner of conducting enquiry imposing penalty and appeal procedures in case of violation of certain provisions of the Pharmacy Act, 1948, in tune with the amendments notified in the Jan Vishwas (Amendment of Provisions) Act, 2023.

Regulation 176

Regulation Pharmacy Clinical Trials Clinical Trials 176

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

Clinical Trials 52

Clinical Trials Clinical Trials Regulation Trials 52

Cloudbyz

AUGUST 30, 2024

Clinical trials are the backbone of medical advancements, but their complexity and the regulatory environment pose significant challenges to researchers, sponsors, and clinical trial managers. The challenges include: Operational Complexity: Clinical trials involve multiple sites, patients, and data points.

Compliance 90

Compliance Clinical Trials Clinical Trials Trials 90

ACRP blog

SEPTEMBER 4, 2024

Clinical trials provide the scientific foundation for justifying the safety and efficacy of drugs, biologics, and devices—but are laborious, expensive, and risky. Only 10% of drugs entering clinical trials receive U.S. clinical trial workforce reported burnout since the 2020 COVID-19 pandemic.{4}

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Clinical Trials Clinical Trials Trials Drugs 105

Cloudbyz

APRIL 23, 2024

The landscape of clinical trial management is marked by complexity, with organizations facing numerous challenges in effectively managing trial budgets while ensuring adherence to regulatory requirements and maintaining high standards of quality.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Regulation 98

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.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Compliance 105

Cloudbyz

MAY 17, 2024

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

Life Science 102

Life Science Clinical Trials Clinical Trials Trials 102

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 156

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 327

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.”

Clinical Trials 52

Clinical Trials Clinical Trials Regulation Trials 52

Cloudbyz

AUGUST 30, 2024

In the rapidly evolving landscape of clinical research, data has become one of the most valuable assets. Clinical Trial Management Systems (CTMS) play a pivotal role in managing this data, encompassing everything from patient information and trial protocols to sensitive medical records and regulatory documents.

Compliance 96

Compliance Clinical Trials Clinical Trials Trials 96

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 13, 2022

The National Commission for Homoeopathy has prepared a regulation defining a structure to the Bachelor of Homoeopathic Medicine and Surgery (BHMS) course with changes including incorporation of a methodology to supplement modern advancement, research and technology in Homoeopathy (SMART-Homoeopathy).

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Regulation Medicine Research Clinical Trials 163

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 149

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.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

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.

Regulation 52

Regulation Clinical Trials Clinical Trials Trials 52

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.

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Clinical Trials Clinical Trials Trials Nurses 130

Outsourcing Pharma

JUNE 13, 2024

To guide sponsors, investigators, CROs, and other parties in clinical research, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinical trials.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

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

Vaccination 174

Vaccination Vaccine Clinical Trials Clinical Trials 174

XTalks

MAY 30, 2024

At the forefront of transforming clinical studies is the Clinical Trials Transformation Initiative (CTTI) , which has been instrumental in shaping the future of clinical trials to be more efficient, inclusive and patient-centered.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

AUGUST 9, 2024

Over the past few decades, the landscape of clinical trials has undergone a dramatic transformation, largely driven by advancements in technology and data management practices. Today, over 80% of clinical research utilizes EDC solutions. What are EDC Systems?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

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. For more on data sharing and ePCTs, see the chapter on Data Sharing and Embedded Research.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Regulation 100

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Regulation 98

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

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.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Regulation 64

Advarra

SEPTEMBER 19, 2024

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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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Vaccination Vaccine Clinical Trials Clinical Trials 146

XTalks

JANUARY 17, 2024

In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology. It’s very positive and it’s going to help move forward the pathway for new drugs.”

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Cloudbyz

JULY 30, 2024

Clinical trials are the cornerstone of medical research, driving innovation and advancements in healthcare. Effective management of clinical trials involves rigorous oversight of operations and careful tracking of key metrics to ensure trials are conducted efficiently, ethically, and in compliance with regulatory standards.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

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.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Drugs 97

Pharma Mirror

MAY 7, 2021

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.

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Clinical Trials Clinical Trials Gene Marketing 130

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).

Clinical Trials 184

Clinical Trials Clinical Trials Drugs Regulation 184

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. From legal considerations to data privacy regulations, the challenges facing these teams can be daunting.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Regulation 59

Cloudbyz

JUNE 11, 2023

This transformation has permeated the domain of clinical trials, which is now embracing the concept of decentralized clinical trials (DCTs). This paper delves deep into the universe of DCTs, their distinctiveness from conventional trials, their inherent benefits, existing hurdles, and measures to bolster their adoption.

Clinical Trials 95

Clinical Trials Clinical Trials Trials Compliance 95

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.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Regulation 97