XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

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Pharma Marketing Network

NOVEMBER 23, 2024

Just as a chef relies on quality ingredients for the perfect dish, marketers depend on cutting-edge research to craft campaigns that resonate with their audience. The Connection Between Pharma Research and Marketing Effective marketing starts with understanding your audience.

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Marketing Research Big Data Medicine 52

Worldwide Clinical Trials

FEBRUARY 28, 2023

Rob found out that in 1980, a researcher in Birmingham, England first synthesized a very niche cancer drug in a small lab. Over the next few decades, that drug made its way through clinical trials, securing approval in 2007—just 36 months before Rob was diagnosed in 2010. But what was truly remarkable?

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Velocity Clinical Research

MARCH 23, 2025

Clinical trials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2%

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Antidote

SEPTEMBER 25, 2023

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.

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Imperical Blog

JANUARY 21, 2025

Ive spent my entire adult life immersed in media, marketing, and advertising, long enough to remember the days before digital advertising in clinical trials took over. They… The post Digital Advertising in Clinical Trials: The Real Secret Sauce appeared first on Imperial Clinical Research Services Blog.

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Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. What Differentiates Mid-Size CROs? To learn more about our end-to-end services, contact us today.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Gilead Sciences has received the European Commission’s (EC) expanded marketing authorisation for Biktarvy (bictegravir 30mg / emtricitabine 120mg / tenofovir alafenamide 15mg tablets) for treating human immunodeficiency virus (HIV) infection in virologically suppressed children.

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Velocity Clinical Research

NOVEMBER 12, 2024

Over the past decade, Germany’s share of global clinical trial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinical research and drug development issues.

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Worldwide Clinical Trials

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. But how can the patient experience be leveraged to drive your trial’s success? And, frankly, none of them are wrong.

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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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Worldwide Clinical Trials

JANUARY 6, 2025

Similarly, the EMAs PRIority MEdicine (PRIME) designation and conditional marketing authorization enable accelerated approval for drugs addressing critical and underserved medical needs, provided they meet stringent evidence requirements.

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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.

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XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7

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Trials Clinical Trials Clinical Trials Gene Therapy 104

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 19, 2025

The Indian Council of Medical Research (ICMR) is working to set up a Centre for Advanced Research in Aging, marking a significant move in India’s efforts to address the challenges of aging and age-related diseases.

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Pharmaceutical Technology

AUGUST 24, 2022

The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1% Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies.

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Clinical Trials Clinical Trials Trials Development 130

Worldwide Clinical Trials

OCTOBER 19, 2022

BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. As evidence emerges about their potential for PTSD, depression, cancer-related distress and more, the market for psychedelics could swell from $2 billion in 2020 to $10.75 Managing the ethics of psychedelic trials.

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ACRP blog

JANUARY 14, 2025

Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct, and reporting within the global ecosystem. A key question is what kind of behavior changes can help us improve as clinical research professionals? appeared first on ACRP.

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Clinical Research Research Clinical Trials Clinical Trials 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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XTalks

JULY 29, 2024

Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history.

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Clinical Trials Clinical Trials Trials Research 105

Advarra

MARCH 7, 2025

Clinical research is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. It is the foundation of medical innovation.

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Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

JANUARY 8, 2024

Getting a drug to market used to be a relatively simple and straightforward affair. 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. That’s just not the case anymore.

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Clinical Trials Clinical Trials Trials Gene Therapy 105

XTalks

SEPTEMBER 27, 2023

As advancements in research forge ahead, it is imperative to ensure patients are informed about and can access potentially life-saving clinical trials. At the forefront of these efforts is Andrea Goodman, who was the Senior Vice President of Patient Support and Research Strategy at the Colorectal Cancer Alliance.

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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. Your CRO can also play a crucial role in helping you to understand existing precedents and how they apply to your study and overall development journey.

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Cloudbyz

JUNE 9, 2024

In the realm of clinical trials, particularly in oncology and rare disease research, SDOH play a pivotal role in shaping patient participation, adherence, and overall outcomes. Integrating eClinical systems can help mitigate these disparities, enhancing the inclusivity and efficacy of clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 105

NPR Health - Shots

AUGUST 9, 2022

Researchers are hoping to change that. There isn't currently a Lyme disease vaccine on the U.S. Image credit: Bertrand Guay/AFP via Getty Images)

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Clinical Trials Clinical Trials Vaccine Vaccination 145

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.

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ACRP blog

JUNE 30, 2023

Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Do you lose revenue in research? Are you calculating fair market value correctly?

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Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. There are only two marketed treatments for ALS in the US.

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Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

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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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Velocity Clinical Research

OCTOBER 21, 2024

At the beginning of September, Velocity Clinical Research topped Business North Carolina ’s 2024 Fast 40 list. It was our third time receiving the award, which recognizes the fastest-growing mid-market businesses in the state. For a clinical trials organization to achieve this level of scale is notable.

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Pharmaceutical Technology

NOVEMBER 8, 2022

Additionally, Neurophth will oversee the clinical trials and marketing of gene therapy products developed leveraging the new AAV capsids of Cyagen. Under the collaboration, Cyagen is entitled to get research phase and clinical phase milestone payments and sales-based royalty payments totalling over $140m.

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AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]

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XTalks

MARCH 12, 2025

Following the success of Issue 3 , which focused on the critical importance of patient diversity in clinical research, Xtalks is thrilled to announce Xtalks Clinical Edge Issue 4. These prominent leaders will share their experiences, strategies and visions about whats next for clinical research.

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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.

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Clinical Trials Clinical Trials Trials Clinical Research 97

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 1, 2023

India’s advanced wound care market is on the growth trajectory with faster healing & minimised scarring. This is where the positive acceptance of Negative Pressure Wound Therapy (NPWT) that uses a vacuum dressing to ensure healing in acute and chronic conditions in India is gaining popularity.

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