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.

Regulation 96

Regulation Medicine Life Science Development 96

Cloudbyz

APRIL 3, 2023

AI/ML-based PHI and PII redaction solutions can help in clinical research by automating the process of identifying and redacting sensitive information from documents, images, and other digital content. This can help protect patient privacy, ensure compliance with data protection regulations, and reduce the risk of data breaches.

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Clinical Research Research Regulation Compliance 52

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 106

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.

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Clinical Research Research Clinical Trials Clinical Trials 124

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

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.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

XTalks

JUNE 11, 2024

Askanase shares her insights on the crucial role of patient voices in shaping research, offering hope for new, more effective lupus treatments. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 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.

Clinical Research 59

Clinical Research Research Life Science Clinical Trials 59

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

BioPharma Reporter

MARCH 7, 2022

Clinical Research Organization Veristat has acquired SLF (Solutions for Life Sciences): adding capabilities to support biotech, pharmaceutical and medtech companies.

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XTalks

APRIL 13, 2022

The webinar concluded with Kyle Haas, Associate Director, Clinical Trial Management, Medpace, speaking about the operational and study start-up considerations for pediatric rare disease clinical research. Aspects of Pediatric Medical Research. Challenges in Pediatric Rare Disease Clinical Trials.

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Clinical Trials Clinical Trials Clinical Research Trials 97

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

XTalks

AUGUST 9, 2024

Pharmaceutical, life sciences and healthcare organizations have long had the desire to make their research programs more accessible and patient-centric. One of the key elements to the successful execution of a decentralized clinical trial (DCT) is providing patients access to in-home specimen collections and assessments.

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Clinical Trials Clinical Trials Trials Clinical Research 52

The Pharma Data

NOVEMBER 10, 2020

Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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Life Science Clinical Trials Clinical Trials Trials 40

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. Keep it simple.

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Clinical Trials Clinical Trials Trials Clinical Research 111

Cloudbyz

APRIL 6, 2023

Naperville, Illinois – April 6, 2023 : Cloudbyz, an innovative digital clinical research solutions provider, today announced a new partnership with Odaseva, the leading Enterprise Data Protection Platform built specifically to address the needs of the largest Salesforce customers.

Life Science 52

Life Science Clinical Research Compliance Clinical Trials 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

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.

Development 93

Development Clinical Trials Clinical Trials Gene Therapy 93

Cloudbyz

AUGUST 26, 2024

Implementing a Clinical Trial Management System (CTMS) is a critical step for any life sciences organization aiming to enhance the efficiency, compliance, and oversight of their clinical trials. However, a successful CTMS implementation goes beyond merely choosing the right software.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

XTalks

MAY 9, 2023

In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers. If you’re considering a career in clinical research, read on to learn more about this rewarding career. What Does a Clinical Trial Manager Do?

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Clinical Trials Clinical Trials Trials Clinical Research 90

ACRP blog

APRIL 5, 2023

AI is increasingly important in drug discovery and development as well as clinical trials, operations, pharmacovigilance, and many other areas.” This has led to the emergence of a new ‘pharmaceutical intelligence’ that has allowed the industry to move away from traditional, slow-moving, and costly processes,” Lyons writes. “AI

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Clinical Trials Clinical Trials Big Data Life Science 52

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. Underserved populations needed these therapies yesterday and the next generation requires us to step up,” he adds.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Life Science 101

pharmaphorum

FEBRUARY 4, 2021

Adams believes this positive start to the year is a sign that life science and medical device companies are looking for expert partners who understand the operational and regulatory challenges facing them and can deliver scalable solutions that meet their unique requirements. “It

Life Science 52

Life Science Clinical Trials Clinical Trials Regulation 52

Pharma Business Blog

MARCH 15, 2023

The Clinical Trial Regulation (“CTR”) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS. • Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

JULY 1, 2021

Only a year after the emergence of COVID-19, a handful of life science companies started publishing data on the encouragingly high efficacy of their vaccine candidates. It’s a miracle of modern science, but it didn’t happen in a single flash of brilliance out of the blue.

Vaccination 96

Vaccination Vaccine Development Life Science 96

pharmaphorum

DECEMBER 11, 2022

So, when a life sciences company embarks on a project of digital transformation or innovation, it’s really embarking on multiple projects that span the wide world of pharmaceutical operations. Hadjiat says the team can build digital tools for clinicians because they have a team that represents both technical and clinical expertise.

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Life Science Clinical Research Development Research 137

Pharma Business Blog

NOVEMBER 24, 2022

EU pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favorable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.

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Clinical Trials Clinical Trials Trials Research 52

XTalks

NOVEMBER 15, 2024

Bexicaserin, an investigational oral therapy, works by activating specific brain receptors, notably the 5-HT2C receptor, which helps regulate neurological functions. She noted that DEEp OCEAN is a step towards inclusivity in clinical research.

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Trials Clinical Trials Clinical Trials Genetics 88

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 119

Clinical Trials Clinical Trials Trials Gene Therapy 119

pharmaphorum

FEBRUARY 11, 2021

As the COVID-19 pandemic heralds a major shift towards remote, virtual and hybrid clinical trial models, patient engagement is becoming even more relevant, but every country will have its own rules on how to interact with patients and their representative organisations.

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Clinical Trials Clinical Trials Trials Clinical Research 91

XTalks

JUNE 10, 2024

Efruxifermin is a novel Fc-FGF21 fusion protein designed to emulate the activity of native FGF21, an endogenous hormone that regulates metabolism and alleviates cellular stress. Numerous compounds are currently under clinical investigation for MASH. This comprehensive action of efruxifermin addresses the multifaceted nature of MASH.

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Insulin Life Science Regulation Hormones 52

XTalks

MAY 28, 2024

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. Clay is optimistic about the trajectory of DHTs in clinical trials.

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Clinical Development Development Clinical Trials Clinical Trials 114

XTalks

SEPTEMBER 30, 2024

XTALKS WEBINAR: Optimizing Clinical Trial Protocols: How Digitized Protocols are Accelerating Clinical Research Live and On-Demand: Monday, November 4, 2024, at 12pm EST (5pm GMT/UK) Register for this free webinar to gain insights into protocol digitization, understand how it can drive efficiencies and discover how it can elevate clinical trials.

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Clinical Trials Clinical Trials Dermatology Trials 90

pharmaphorum

OCTOBER 27, 2022

Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders? About the authors.

Life Science 96

Life Science Compliance Medicine Regulation 96

XTalks

DECEMBER 4, 2023

Matthew Confeld, PharmD, PhD Assistant Director, Clinical Research Methodology, Worldwide Clinical Trials In this Xtalks Spotlight edition, Xtalks spoke with Matthew Confeld, PharmD, PhD, Assistant Director of Clinical Research Methodology at Worldwide Clinical Trials , about Project Optimus and what it means for oncology programs.

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Development Drugs Clinical Trials Clinical Trials 109

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Myth 1: There are too many challenges with adopting an ECA.

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Clinical Trials Clinical Trials Life Science Trials 73