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

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

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

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

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+ Dr Olena Karpenko.

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Clinical Research Research Clinical Trials Clinical Trials 52

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 98

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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Life Science Clinical Research Research Regulation 96

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

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry. The key challenge for all regulators next year is ensuring that they can keep up with the progress of the technology.”

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Genome Genomics Life Science Gene Therapy 139

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 110

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.

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Life Science Compliance Clinical Research Clinical Trials 52

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 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 98

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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Big Data Clinical Trials Clinical Trials 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

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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.

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Clinical Trials Clinical Trials Trials Regulation 52

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

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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Clinical Trials Clinical Trials Trials Gene Therapy 124

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

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

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 111

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

pharmaphorum

MAY 27, 2022

wearable device carried by patients to measure certain health-related parameters, remote patient monitoring) and tele-healthcare in clinical trials (e.g. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. video consultations), health data analytics (e.g. What comes next?

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Clinical Trials Clinical Trials Trials Packaging 79

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.

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Life Science Compliance Regulation Cosmetics 96

pharmaphorum

JULY 8, 2022

“They can solve some immediate challenges with participation in research by conducting eCOA (electronic clinical outcome assessment) remotely or doing virtual visits. We have also seen the regulators actively support the use of these hybrid decentralised research approaches.

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Clinical Trials Clinical Trials Trials Regulation 89

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 75

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

ACRP blog

SEPTEMBER 12, 2022

Pavlovic, MD, a life science executive coach with Heruka Health Innovations and contributor to ACRP’s Clinical Researcher journal, when it comes to self-leadership, “the process of control is ultimately self-imposed rather than externally mandated.” Emotion regulation. As explained by Zoran M. Self-efficacy.

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Regulation Life Science Clinical Research Production 98

XTalks

APRIL 6, 2023

The growth of ecommerce has spurred expectations of consumer-like experiences in the life sciences industry. Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinical trial.

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Clinical Trials Clinical Trials Clinical Supply Trials 98

XTalks

DECEMBER 28, 2023

It stands out as the sole reported therapy under clinical evaluation for treating alloimmunized pregnant individuals at significant risk of severe HDFN.

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Trials Clinical Trials Clinical Trials Antibody 97

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. The regulation outlines requirements for using electronic signatures, such as unique identification codes and two distinct identification components. Let’s explore.

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Compliance Clinical Trials Clinical Trials Trials 95

XTalks

DECEMBER 22, 2022

NORD, along with its more than 330 member patient organizations, is committed to the identification, treatment and cure of rare disorders through education, advocacy, research and patient services. Since only about 5 percent of rare diseases have FDA-approved treatments, it is vital that we increase the pace of rare disease clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

DECEMBER 16, 2020

Soon the ABPI and the entire industry were facing the ripple effects of COVID-19, including a significant slowdown in non-COVID clinical research, which Torbett says was challenging for the industry to deal with. “We’ve “It’s been a very interesting year to kick things off.”. We’re very grateful for that.

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Vaccination Vaccine Life Science In-Vitro 121

pharmaphorum

JANUARY 13, 2021

The acute phase of the COVID-19 pandemic tested the UK’s capacity and capability to rapidly deliver crucial clinical research at a time of immense pressure and stress on personnel and resources. Dr Kirsty Wydenbach is an expert medical assessor and the deputy unit manager in the Clinical Trials Unit at MHRA , having joined in 2009.

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Research Clinical Trials Clinical Trials Trials 52

pharmaphorum

JANUARY 13, 2021

The acute phase of the COVID-19 pandemic tested the UK’s capacity and capability to rapidly deliver crucial clinical research at a time of immense pressure and stress on personnel and resources. Dr Kirsty Wydenbach is an expert medical assessor and the deputy unit manager in the Clinical Trials Unit at MHRA , having joined in 2009.

Research 52

Research Clinical Trials Clinical Trials Trials 52