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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Clinical Research Research Clinical Trials Clinical Trials 52

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%

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

Rethinking Clinical Trials

FEBRUARY 21, 2024

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” He also serves as co-principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Join the online meeting.

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Clinical Trials Clinical Trials Trials Bioinformatics 130

pharmaphorum

JANUARY 17, 2023

Late last year, pharmaphorum spoke with AstraZeneca’s Ben Challis, VP and head of translational science and experimental medicine, cardiovascular, renal, and metabolism (CVRM), together with Magnus Jörnten-Karlsson, executive director of Unify. Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool.

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Clinical Trials Clinical Trials Medicine Trials 98

Rethinking Clinical Trials

JUNE 28, 2023

Hernandez is a professor of medicine and director of the Duke Clinical Research Institute at Duke University; he is a co–principal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center. Dr. Lipset is cochair of the Decentralized Trials & Research Alliance. Join the online meeting.

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Clinical Trials Clinical Trials Trials Clinical Research 130

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 17, 2024

Biology is opening up new frontiers in medicine. We are witnessing a revolution in healthcare, driven by advances in genetics, Omics, RNA and CRISPR gene-editing technology, to deliver precision and personalised medicine, said Kiran Mazumdar-Shaw, executive chairperson, Biocon and Biocon Biologics.

Genetic Disease 189

Genetic Disease Genetics Gene Editing Medicine 189

Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

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Clinical Research Research Gene Therapy Drugs 226

Worldwide Clinical Trials

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. Reduces Trial Failures Oftentimes, clinical trials may fail due to a lack of efficacy.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Rethinking Clinical Trials

JUNE 27, 2022

A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face. The special issue can be found on the Contemporary Clinical Trials website.

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Clinical Trials Clinical Trials Trials Clinical Research 111

Rethinking Clinical Trials

OCTOBER 22, 2023

What Are Pragmatic Clinical Trials? Description In this video, Dr. Lesley Curtis describes pragmatic clinical trials. The post What Are Pragmatic Clinical Trials? The post What Are Pragmatic Clinical Trials? appeared first on Rethinking Clinical Trials.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Clinical Research 100

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 Clinical Research 126

Worldwide Clinical Trials

AUGUST 10, 2023

The Psychedelic Community Casts a Wide Net Along with a robust community of scientific researchers and medical practitioners, Psychedelic Science included artists, educators, religious and cultural leaders, philanthropists, patient and policy advocates, and many more.

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Clinical Trials Clinical Trials Trials Clinical Research 246

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

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 10, 2024

By focusing on clinical excellence, comprehensive education, and cutting-edge research, the Arya Vaidya Pharmacy Research Foundation (AVPRF) based in Coimbatore is ensuring that ayurvedic practices are validated, credible, and relevant for future generations.

Medicine 233

Medicine Pharmacy Research Clinical Trials 233

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.

Clinical Research 130

Clinical Research Research Nurses Clinical Trials 130

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.

Clinical Research 130

Clinical Research Research Nurses Clinical Trials 130

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.

Clinical Research 130

Clinical Research Research Nurses Clinical Trials 130

Deltaclinical

DECEMBER 9, 2022

Clinical trials in drug development are a vital part of the process to bring new medicines to patients. We have recognized this need and offer flexible and fast services that can be custom tailored, specifically to meet all study protocols.

Clinical Research 130

Clinical Research Research Nurses Clinical Trials 130

Rethinking Clinical Trials

APRIL 18, 2023

Learn more Visit [link] Discussion Themes – What experts are being convened for the different trials? We have people with experience with post-viral symptoms, treating ME/CFS, general COVID knowledge, biomarker experience, clinical trials, patient-reported outcomes, and more. It’s all over the place.

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Clinical Trials Clinical Trials Trials Immune Response 169

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

XTalks

APRIL 13, 2022

Pediatric rare disease clinical trials are vital to determining the safety and efficacy of medications for children living with a rare disease. Therefore, pediatric rare disease clinical trials are vital to determining the safety and efficacy of medications for children living with a rare disease.

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Clinical Trials Clinical Trials Clinical Research Trials 98

Rethinking Clinical Trials

JULY 31, 2023

Building a Study Team for a Pragmatic Clinical Trial Description NIH Collaboratory investigator Dr. Lesley Curtis shares tips for building effective study teams for pragmatic clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 100

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

MARCH 28, 2023

Indian pharma is now accelerating its pace towards interdisciplinary research for medicines to combat diseases.

Medicine 183

Medicine Research Clinical Trials Clinical Trials 183

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. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

Clinical Development 341

Clinical Development Clinical Trials Clinical Trials Trials 341

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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Clinical Trials Clinical Trials Trials Regulation 130

Rethinking Clinical Trials

APRIL 17, 2024

Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The YODA Project promotes open science, research transparency, and the sharing of clinical research data to support healthcare research.

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Clinical Trials Clinical Trials Clinical Research Trials 167

Rethinking Clinical Trials

DECEMBER 20, 2023

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. Further efforts are urgently needed to increase diversity in the cardiology workforce, which will improve clinical trial diversity and cardiovascular health for all.

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Clinical Trials Clinical Trials Trials Cardiology 135

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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Clinical Trials Clinical Trials Trials Gene Therapy 105

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

Trials 104

Trials Clinical Trials Clinical Trials Gene Therapy 104

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].

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 11, 2023

The pharma companies’ thrust on R&D to develop better medicines and the demand in hospitals for advanced medical technologies driven by artificial intelligence, remote patient monitoring and wearables are transforming patient care.

Medicine 188

Medicine Development Pharma Companies Clinical Trials 188

FDA Law Blog

FEBRUARY 27, 2025

The European Medicines Agency (EMA) has adopted E6(R3) Principles and Annex 1 to take effect on July 23, 2025, and other ICH member nations and regions are still in the process of adopting E6(R3). No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3). Below, we explore some of the key themes seen in the changes.

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Clinical Trials Clinical Trials Trials Clinical Research 88

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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Clinical Research Research Clinical Trials Clinical Trials 105

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.”

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

Pharmaceutical Technology

JUNE 30, 2022

In the wake of Russia’s invasion of Ukraine, sponsors are increasingly evaluating other European countries to conduct their clinical trials. Among them, the Eastern European nation of Georgia has emerged as a key rescue country for multinational clinical trials that were put on hold due to the war. Room to grow.

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Clinical Trials Clinical Trials Trials Licensing 130

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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