XTalks

FEBRUARY 14, 2023

The life science industry is constantly evolving, making it difficult to stay ahead of the curve. Digital transformation is burgeoning and we aim to cover some of the dominant emerging technologies that are currently running the life science industry by storm.

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Pharmaceutical Technology

JUNE 20, 2023

Most of us have heard of ChatGPT and AI but where and how do they fit into the life sciences ecosystem? Macroeconomic includes quantum computing, and for regulatory, data privacy and algorithmic bias regulation are predicted to be major themes moving forward. Can AI transform document translation?

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Life Science Clinical Trials Clinical Trials Regulation 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 100

XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

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Pharmaceutical Technology

JULY 8, 2022

VDRs may be used for asset sales, audit tenders, bankruptcies, due diligence processes, mergers & acquisitions, public and private debt and equity capital raising, clinical trials, and organisational restructuring. Regulations protecting everything are made more robust. Privacy and security. Security is made more secure.

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pharmaphorum

OCTOBER 1, 2020

Many companies in the life sciences industry are slow to adopt new technologies. Running clinical trials costs a lot of money! Many clinical trials fail. For example, it can be difficult to recruit patients or they may drop out during the trial. What is meant by automating clinical trials?

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Clinical Trials Clinical Trials Trials Production 111

Pharmaceutical Technology

SEPTEMBER 23, 2022

Rivus Pharmaceuticals has raised $132m in a Series B funding round to clinically advance its lead candidate, HU6, for the treatment of obesity and cardio-metabolic disorders. RA Capital Management led the financing round, which also saw participation from Bain Capital Life Sciences and BB Biotech.

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XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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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

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Clinical Trials Clinical Trials Trials Life Science 101

XTalks

NOVEMBER 28, 2024

By enhancing wakefulness and regulating muscle tone, it addresses excessive daytime sleepiness and cataplexy, the disorder’s two hallmark symptoms. Narcolepsy disrupts sleep-wake regulation, leading to fragmented nighttime sleep, cognitive impairments and sudden muscle weakness triggered by strong emotions.

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Clinical Trials Clinical Trials Trials Regulation 103

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Safety will create a single source of truth for content management.

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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

XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. Evolution in Oncology Clinical Trial Design Recent discussions at ESMO highlight a shift in how clinical trials are designed and conducted.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Cloudbyz

MARCH 1, 2023

Clinical trials are a critical component of drug development in the life sciences industry. Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments. Following are the benefits of digitizing clinical trials budgets and payments.

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Clinical Trials Clinical Trials Trials Compliance 98

XTalks

JULY 6, 2022

The adoption of decentralized clinical trial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Rachel Colite, VP Decentralized Clinical Trials, Cogstate.

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Clinical Trials Clinical Trials Trials Licensing 98

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

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

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

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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Clinical Trials Clinical Trials Compliance Trials 98

Cloudbyz

JANUARY 27, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ Setting up a virtual clinical trial: Things to consider. The pharmaceutical industry has been forced to find new and innovative approaches to try clinical trials. eCOA / ePRO.

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Clinical Trials Clinical Trials Trials Packaging 98

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 111

XTalks

DECEMBER 9, 2024

This shift not only prioritizes patient safety but also ensures that ineffective treatments are identified more quickly.

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Clinical Trials Clinical Trials Compliance Trials 105

Pharma Business Blog

JULY 22, 2020

The year 2020 has seen a lot of development in the way we do business such as new regulations and smarter solutions to solve old and new challenges. Find out more about each of PwC’s Pharma & Life Sciences Hot Topics 2020 in the attached PDF below. PwC’s Pharma & Life Sciences Hot Topics Download.

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Life Science Clinical Trials Clinical Trials Regulation 52

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

Cloudbyz

SEPTEMBER 11, 2024

This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide. This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to life sciences organizations worldwide.

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Life Science Clinical Trials Clinical Trials Compliance 52

XTalks

MAY 21, 2024

Yesterday, on International Clinical Trials Day 2024, the global healthcare community came together to commemorate the significant advancements in clinical research and the vital role clinical trials play in improving patient care and outcomes.

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Clinical Trials Clinical Trials Trials Clinical Research 64

Imperical Blog

JANUARY 9, 2024

Diversity in clinical trials is becoming mandatory, which can make drugs and devices more widely beneficial. New FDA regulations are coming; read on for our understanding of what to expect.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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Clinical Trials Clinical Trials Life Science Trials 130

XTalks

NOVEMBER 15, 2024

The DEEp OCEAN study, a global Phase III, double-blind, placebo-controlled trial, focuses on evaluating bexicaserin’s efficacy by tracking countable motor seizures in over 320 participants aged two to 65. Those who complete the maintenance period can enter a DEEp open-label extension for further observation over a year.

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Trials Clinical Trials Clinical Trials Genetics 97

XTalks

DECEMBER 26, 2024

Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.

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Trials Life Science Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 1, 2023

Basadonna, MD, Chief Medical Officer, Head of Global Medical Strategy, and Annabel de Maria, Chief Patient Officer, recently spoke on a webinar where they shared insights on how to increase patient engagement in clinical trials. The webinar was moderated by their colleague Giulia Pierini, Patient Engagement Principal at Alira Health.

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Clinical Trials Clinical Trials Trials Clinical Development 87

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

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

pharmaphorum

AUGUST 17, 2022

The latest life science competitiveness indicators (LSCIs) were published by the Office of Life Sciences (OLS) in July 2022. The life sciences ecosystem. Interest in indicators. If we aren’t already, we’re all likely to be patients one day, or caregivers of one at some point in the future.

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Life Science Medicine Marketing Regulation 59

Cloudbyz

MARCH 30, 2023

In today’s digital age, life sciences organizations are collecting, storing, and processing vast amounts of sensitive data, including personally identifiable information (PII) and protected health information (PHI). As such, it’s becoming increasingly challenging for organizations to manage and secure this data.

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Cloudbyz

MARCH 17, 2023

Good Clinical Practice (GCP) is an international standard that outlines ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving human subjects. Deviations from the protocol can impact the study’s integrity and raise ethical concerns.

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Clinical Trials Clinical Trials Trials Life Science 52

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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