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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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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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

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

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

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

MARCH 25, 2021

Xtalks is proud to announce the launch of the Xtalks Life Science podcast. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Fresh Conversations About Life Science Topics. Sarah is passionate about science communication and journalistic integrity.

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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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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

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 75

Pharma Business Blog

NOVEMBER 24, 2022

This news will impact all the companies that are doing clinical trials in Europe. EU pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. Dr. Sandra Ragaz , Partner Leader Pharma & Life Science VAT Switzerland +41 79 792 72 98 sandra.ragaz@pwc.ch.

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Clinical Trials Clinical Trials Trials Research 52

pharmaphorum

DECEMBER 15, 2022

Co-chaired by Lord James O’Shaughnessy and Professor Mike Bewick, former deputy national medical director of NHS England (present online), the NHS Innovation and Life Sciences Commission Report launch took place at One Great George Street, Westminster, on 12th December 2022. The UK as a powerhouse of research.

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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

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

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

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Clinical Trials Clinical Trials Trials Regulation 52

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

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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Clinical Trials Clinical Trials Trials Life Science 52

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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Compliance Clinical Trials Clinical Trials Trials 89

Cloudbyz

MARCH 28, 2023

This solution is designed to meet the unique needs of clinical research organizations (CROs) and pharmaceutical companies, offering a range of features to help them streamline their operations, manage clinical trials, and ensure compliance with regulatory requirements.

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Life Science Clinical Trials Clinical Trials Compliance 52

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research.

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Clinical Development Development Clinical Trials Clinical Trials 111

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Clinical Data Pipeline for Data Review and Analyses.

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Clinical Trials Clinical Trials Trials Life Science 98

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

MARCH 5, 2021

For International Women’s Day, Medidata’s global compliance and strategy lead Fiona Maini discusses the importance of increasing female participation in clinical trials and how technology may solve some of the barriers. Levelling the field through technology.

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Clinical Trials Clinical Trials Trials Vaccination 113

pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on.

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Regulation Medicine Life Science Development 88

pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.

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Clinical Trials Clinical Trials Trials Clinical Research 89

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Clinical Trials Clinical Trials Trials Vaccination 105

Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+

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Clinical Research Research Clinical Trials Clinical Trials 52

Cloudbyz

MARCH 15, 2023

March 15, 2023 /PRNewswire/ — Cloudbyz, a leading provider of unified clinical trial management solutions, today announced the launch of its innovative Electronic Data Capture (EDC) product, Cloudbyz EDC 2.0. Designed to revolutionize the clinical research landscape, Cloudbyz EDC 2.0 NAPERVILLE, Ill.

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Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

APRIL 22, 2022

billion, with plans to use the new cash to launch a new initiative to make sure clinical trials are inclusive and diverse. BRIDGE represents the magnitude of impact we aim to make in life sciences in our next decade.” The post Financing pushes value of clinical trial tech firm Reify to $4.8bn appeared first on.

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Clinical Trials Clinical Trials Trials Life Science 52

ACRP blog

SEPTEMBER 20, 2023

Pell: Before I got into life sciences translation, I worked on the client side. Now, working in the language services business with the distinct mission to serve our life sciences clients, it’s vital that messaging is accurate, culturally relevant, and resonates. On a personal level, I was born and raised in the U.S.

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Clinical Research Research Life Science Clinical Trials 59

pharmaphorum

FEBRUARY 1, 2022

The MHRA has kicked off an eight-week consultation on proposals for changes to laws governing the conduct of clinical trials following the UK’s departure from the EU. The post MHRA seeks comments on post-Brexit clinical trial legislation appeared first on. — MHRAgovuk (@MHRAgovuk) January 21, 2022.

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Clinical Trials Clinical Trials Trials Life Science 52

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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Clinical Trials Clinical Trials Trials Clinical Research 104

pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”. Tabakin agrees. “In

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Clinical Trials Clinical Trials Trials Development 106

XTalks

FEBRUARY 24, 2023

When life sciences industry partners with patients and their advocacy communities, the patient voice becomes integrated into the drug development process. It’s an increasingly common and evolving practice that has brought about meaningful change in the clinical trial process.

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Development Clinical Trials Clinical Trials Gene Therapy 98

XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. Patient input is a crucial component of rare disease clinical trials, as it can provide valuable insights into the patient experience and inform decisions about study design and implementation.

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Clinical Trials Clinical Trials Trials Development 97

XTalks

NOVEMBER 7, 2022

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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