AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 16, 2024

per cent of India’s Ayush and herbal products during the fiscal year 2023-24. The top 10 destinations led by USA, Germany and Italy accounted for almost 63.3 Exports to these 10 countries together stood at $412 million, with a growth of 5.10 per cent compared to the $392 million exports to top 10 destinations during […]

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Worldwide Clinical Trials

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)

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Velocity Clinical Research

DECEMBER 27, 2023

Our sites conducted clinical trials that supported 12 U.S. product approvals in 2023, contributing to the betterment of global health. To date, Velocity has contributed to research programs for over 50 product approvals. We’re immensely proud to be at the forefront of medical research.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2024

Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Pricing of biopharmaceutical medicines are influenced by various factors, and the cost of research and development (R&D) plays a significant role in determining drug prices, […]

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Pharmaceutical Technology

MARCH 22, 2023

Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report. Some large pharma companies have initiated indirect reshoring activities by increasing investment in new research and development and production units in their European facilities.

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XTalks

JANUARY 29, 2021

Oncology products monopolise the list of best-selling drugs. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 15, 2024

a global leader in analytical and clinical laboratory technologies, announced that it has received two prestigious awards from SelectScience: Best New Drug Discovery & Development Product of 2023 and Drug Discovery & Development Webinar of the Year. Agilent Technologies Inc.,

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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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ProRelix Research

JULY 6, 2023

Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 23, 2023

The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]

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VirTrial

OCTOBER 6, 2023

Digital health technology (DHT) solutions are now widely adopted and applied in today’s clinical trials. But how can sponsors and clinical research organizations ensure such technologies address the needs and goals of its most pivotal stakeholders – patients and research sites? Evidence assessment. 

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Worldwide Clinical Trials

OCTOBER 19, 2022

BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. Psychedelic products are having a renaissance moment. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. billion in 2027.

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ACRP blog

MAY 6, 2024

Also sharing advice on breaking free of unproductive habits on Saturday was Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Consultant and Owner of Responsibility Research, in her session on “The Intersection of Technology and People: Harnessing Technology to Increase Efficiency and Build Relationships.” On Day Two of ACRP 2024 in Anaheim, Calif.,

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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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Cloudbyz

MAY 23, 2023

Nutraceuticals are food or food products that provide health and medical benefits, including the prevention and treatment of disease. However, just like pharmaceuticals, nutraceuticals must go through rigorous clinical research and testing before being brought to the market.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 24, 2023

Exports of Ayush related products from the country have gone up around 53 per cent in five years from the financial year 2016-17 to 2020-21, according to the Ministry of Ayush. The imports, on the other hand, has increased around 42 per cent during the period, with a majority of the products based on the […]

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Rethinking Clinical Trials

JULY 17, 2023

Kaitlyn McLeod The NIH Pragmatic Trials Collaboratory is welcoming its first class of fellows in a new program for early-career investigators from underrepresented or minoritized groups with a scholarly interest in pragmatic clinical trials. Dr. Stephanie Ibemere is an assistant professor in the Duke University School of Nursing.

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XTalks

JANUARY 8, 2024

Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. It’s important to make sure that with this increase in clinical trial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham.

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Rethinking Clinical Trials

JUNE 15, 2023

This year’s Annual Steering Committee Meeting for the NIH Pragmatic Trials Collaboratory featured two special guests from the U.S. Further, the FDA encourages engagement early and often to understand how the regulations and policies apply to a particular product or technology. The research just needs to go through the right processes.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 3, 2022

In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022.

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Drug Discovery World

MAY 30, 2024

. “We are very pleased to be able to start the clinical programme with our drug candidate IRL757 so soon after the Medical Products Agency’s approval. The Michael J Fox Foundation (MJFF) has awarded a grant of more than SEK 20 million ($2 million) to conduct this first Phase I clinical trial of IRL757.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

Clinical trials were thrown into turmoil on the morning of 24 February 2022, along with every aspect of life in Ukraine. In July, approximately a third of companies had paused a trial in the country. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

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ECRG Media's Clinical Research Podcast

OCTOBER 5, 2023

Clinical Research Nurse Vs Clinical Trails Coordinator Don't forget to Subscribe for new content! Clinical Research is one of the hottest fields in the world right now and thousands of college graduates, masters candidates and phd graduates are looking to enter the clinical research world. Send in a voice message: [link]

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Clinical Trial Podcast

NOVEMBER 5, 2023

Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. Sponsor(s): This podcast is brought to you by Florence Healthcare.

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Pharmaceutical Technology

JUNE 15, 2023

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Pharma R&D teams are solving this problem by leveraging the power of artificial intelligence (AI) in clinical trials to save time and money. Food and Drug Administration approval.

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Worldwide Clinical Trials

MAY 14, 2024

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. Engage stakeholders EARLY.

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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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Pharmaceutical Technology

MAY 18, 2023

For clinical trial participants, dropping out of trials is often due to the distances from their homes to the trial sites, combined with unexpected costs and number of visits needed. Add in complex trial protocols, and many participants have reported feeling a lack of patient engagement and support [i].

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Rethinking Clinical Trials

OCTOBER 4, 2022

Senior Director Clinical Trial Operations. Neurological Clinical Research Institute. Clinical Trial Transformation Initiative (CTTI); Decentralized Clinical Trials (DCTs); Digital endpoints; Developing novel endpoints. Decentralized trials require novel technology and digital endpoints. Marianne Chase. ETH Zurich.

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pharmaphorum

OCTOBER 28, 2022

The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This will ensure that you are developing a product these audiences will use.

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Pharmaceutical Technology

AUGUST 26, 2022

Last week, the collaborative announced that it is executing a joint development agreement (JDA) to advance two novel drug regimens to Phase II clinical trials by 2023. All members of the PAN-TB collaboration have previous experience in TB therapeutic research. Each trial will recruit approximately 500 patients.

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ACRP blog

JANUARY 30, 2024

“We’re seeing significant innovations in the medical product development industry, and true innovation can cause some consternation in such a highly regulated sector,” says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, at the U.S.

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Roots Analysis

OCTOBER 29, 2023

One particular area that has seen significant innovation is the realm of clinical trials. Traditionally conducted at centralized sites like hospitals or clinics, the latest trend is moving towards decentralized clinical trials (DCTs). Decentralized clinical trials (DCTs) can be a solution to all the aforementioned challenges.

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Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

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Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. These advancements have fostered increased focus from politicians, policymakers, and the investment communities backing academic and industry-sponsored research projects. Available across the globe Established efficacy in two adequate and well-controlled trials.

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Imperical Blog

NOVEMBER 28, 2023

Clinical trial labeling is complex. Discover how Imperial CRS helped a client overcome some of the complexities of this critical clinical trial component. Did you know that product labels are big business?

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