XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Cloudbyz

APRIL 20, 2023

The European Union (EU) Clinical Trial Regulation (CTR) No 536/2014, which came into effect in January 2022, has significantly changed the clinical trial landscape in the EU. It streamlines and harmonizes the clinical trial application process while maintaining high standards of patient safety and data quality.

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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

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 125

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. There is data to support this possibility.

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Drug Discovery World

FEBRUARY 8, 2023

A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases. For example, US Census Bureau data indicates 13.4%

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Worldwide Clinical Trials

OCTOBER 19, 2022

BioPharma Dive interviewed our Christine Moore on how to conduct psychedelic clinical research. With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. These trials are often someone’s last hope,” Moore said.

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Clinical Trials Clinical Trials Trials Production 130

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 99

pharmaphorum

APRIL 26, 2022

Making sure clinical trials are diverse and representative of the populations they’re studying isn’t just the right thing to do to promote inclusivity and equity; it’s also just good science/clinical scientific practice. Potential barriers that exclude communities from clinical research.

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Clinical Trials Clinical Trials Trials Regulation 98

Velocity Clinical Research

MAY 30, 2024

Being a clinical research site organization that deals with sensitive patient data, it is encouraging and comforting to see that these models consider privacy, security, and compliance as critical factors. Aspects of GPT-4o are General Data Protection Regulation (GDPR) and California Consumer Privacy Act (CCPA) compliant.

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Clinical Trials Clinical Trials Trials Life Science 59

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Can you tell us a bit about the work you are doing at NORD and how it impacts clinical trials for rare diseases?

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Clinical Trials Clinical Trials Trials Clinical Research 98

ACRP blog

FEBRUARY 15, 2023

As we mark Black History Month, what are your thoughts on overall efforts to improve diversity within the clinical trials ecosystem? I am encouraged by how focused we are as an industry on addressing the serious underrepresentation of diverse populations in clinical trials. Although I was quite happy that the U.S.

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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

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 78

XTalks

FEBRUARY 22, 2021

Clinical research is part of a growing industry that provides individuals with rewarding career options and a ladder to climb. Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. Wondering which clinical research job is right for you?

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ACRP blog

OCTOBER 19, 2022

In the turbulent waters of the clinical research workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and around the worst of the storm. It required us to look at student frustrations in finding jobs in clinical research,” Traynor says. “We

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Clinical Research Research Clinical Trials Clinical Trials 98

Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Clinical Research Research Clinical Trials Clinical Trials 105

XTalks

DECEMBER 4, 2023

This was because higher doses often correlated with a better reduction in tumor size, so trial designs were predicated on obtaining the maximum tolerated dose (MTD). But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy.

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Development Drugs Clinical Trials Clinical Trials 111

pharmaphorum

JANUARY 25, 2021

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. clinical trial diversity.

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Clinical Research Research Clinical Trials Clinical Trials 123

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 72

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

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Clinical Trials Clinical Trials Trials Clinical Development 87

pharmaphorum

DECEMBER 19, 2022

The EU has published new recommendations aiming to encourage the use of decentralised clinical trials (DCTs) – and to make sure patients who participate in them have their sights an wellbeing safeguarded. The also includes an overview of national provisions for specific DCT elements to be used in clinical trials.

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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.

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Clinical Trials Clinical Trials Trials Compliance 73

XTalks

FEBRUARY 23, 2024

Chicago-based Linden Capital Partners and Canada’s Ontario Teachers’ Pension Plan are partnering with Elligo Health Research to launch a platform focused on advancing clinical research. This collaboration aims to leverage Elligo’s expertise in healthcare research, utilizing their innovative approaches to clinical trials.

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Clinical Research Research Clinical Trials Clinical Trials 59

ACRP blog

JULY 6, 2022

“The time for pontification is over when it comes to improving diversity in the clinical trial population,” says Reginald Swift, PhD, founder and CEO of Rubix Life Sciences. Industry has been too traditional in its thinking about how to truly promote patient diversity in the clinical trial population, he says. “We

Clinical Trials 101

Clinical Trials Clinical Trials Trials Life Science 101

Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Let’s explore.

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XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. The COVID-19 pandemic certainly has pushed to the forefront of clinical trials, the digital evolution in clinical research. MRI scan, endoscopy, etc.)

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Clinical Trials Clinical Trials Trials Clinical Research 98

Cloudbyz

MARCH 13, 2023

Clinical trial data management involves collecting, processing, analyzing, and reporting data from clinical trials in a systematic and efficient manner. Effective data management is critical for ensuring the safety and efficacy of the tested intervention and maintaining the integrity of the trial results.

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Clinical Trials Clinical Trials Trials Compliance 52

Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

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Clinical Research Research Clinical Trials Clinical Trials 52

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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Cloudbyz

JUNE 13, 2023

Introduction: Clinical trials are essential for evaluating the safety and efficacy of new medical treatments, therapies, and interventions. Developing an accurate and comprehensive budget is crucial for successful trial planning and execution. Site Selection: Careful site selection is critical for optimizing trial costs.

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Clinical Trials Clinical Trials Trials Marketing 68

XTalks

OCTOBER 18, 2022

A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. Read on to learn why life science and clinical research professionals are choosing a career with Medpace.

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Clinical Research Research Clinical Trials Clinical Trials 111

Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

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Clinical Trials Clinical Trials Production Trials 52

Cloudbyz

MAY 15, 2023

Clinical trials play a critical role in medicine and healthcare, offering valuable insights that inform treatment options, drug development, and patient care. As such, the integrity of data collected during these trials is paramount. Audits can reveal systemic issues and provide opportunities for improvement.

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Clinical Trials Clinical Trials Trials Compliance 71

Find Me Cure

SEPTEMBER 2, 2020

As part of our patient advocacy efforts, at FindMeCure we are dedicated to creating a bridge between patients and the world of clinical research. This includes spreading clinical trial awareness, connecting patients to the trials they are interested in but also speaking up about the issues in the clinical research industry. .

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Clinical Research Research Clinical Trials Clinical Trials 97

XTalks

JANUARY 17, 2024

Lupus, a complex autoimmune disease, has brought a substantial challenge to researchers and healthcare professionals. Understanding this condition and its various manifestations, as well as developing effective treatments, has been the focus of ongoing investigation in lupus clinical research for many years.

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