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 98

XTalks

JANUARY 17, 2024

Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. 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.

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Clinical Trials Clinical Trials Trials Gene Therapy 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.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

Trials 97

Trials Clinical Trials Clinical Trials Antibody 97

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

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+

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 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. 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

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

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

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.

Clinical Trials 97

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

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?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

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

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.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Clinical Research 101

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 109

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.

Compliance 86

Compliance Clinical Trials Clinical Trials Trials 86

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 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. In DCTs/HCTs, one or more components of the trial can be managed remotely from the patient’s home using wearable and remote monitoring technology. MRI scan, endoscopy, etc.)

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

APRIL 10, 2023

The adoption of decentralized clinical trial (DCT) approaches has increased exponentially. Tools such as electronic consent, telehealth appointments and wearable devices have enabled investigators to contact trial participants virtually. What are some barriers to adopting DCT methods in oncology trials?

Trials 97

Trials Clinical Trials Clinical Trials Clinical Research 97

pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinical trials that are intended to generate data for regulatory submission to support a new drug license.

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Trials Clinical Trials Clinical Trials Life Science 104

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. We’re already seeing biotechs making breakthroughs with AI in this area, with more than 150 small molecule drugs discovered and 15 already in clinical trials.

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Genome Genomics Life Science Gene Therapy 139

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. NEW YORK and LONDON, Nov.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

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

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. StudyTeam recently added diversity reporting to its functionality, so trial sponsors can monitor enrolment and take immediate action to help increase representation where needed. BRIDGE project.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

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

Big Data 52

Big Data Clinical Trials Clinical Trials Life Science 52

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). This process is becoming increasingly complex due to the larger volume of data being collected in modern clinical trials compared to a decade ago.

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Development Drugs Clinical Trials Clinical Trials 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 Compliance Clinical Research Clinical Trials 52

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

Clinical Trials 109

Clinical Trials Clinical Trials Trials Development 109

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.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Development 97

Cloudbyz

MARCH 25, 2021

Any life science solution built on the Salesforce platform enables a cloud based communication model for the customers, partners, and all other stakeholders. for the period 2020-2030 (Source: PS market research). Why is Salesforce so popular especially in the life science industry, especially to CTMS vendors?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

MARCH 25, 2021

Any life science solution built on the Salesforce platform enables a cloud based communication model for the customers, partners, and all other stakeholders. for the period 2020-2030 (Source: PS market research). Why is Salesforce so popular especially in the life science industry, especially to CTMS vendors?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

AUGUST 31, 2021

ECAs are being used to support the primary approval, label expansion of their assets and even go/no-go decisions for trials. For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. Myth 1: There are too many challenges with adopting an ECA.

Clinical Trials 89

Clinical Trials Clinical Trials Life Science Trials 89

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

FEBRUARY 4, 2021

It comes as PRISYM ID announces five new business wins for the start of 2021, with new accounts spanning clinical trials, pharmaceutical and medical device sectors and with significant growth of the company’s flagship PRISYM 360 platform in the Cloud.

Life Science 52

Life Science Clinical Trials Clinical Trials Regulation 52

XTalks

MAY 7, 2024

XTALKS CLINICAL EDGE: Issue 2 — Special Focus on Rare Disease Clinical Research Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Clinical Research 52

XTalks

SEPTEMBER 17, 2020

In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Verifying the biomarker’s clinical validity for use as a surrogate endpoint in rare disease research is another hurdle which is generally a longer-term goal.

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Trials Gene Hormones Clinical Trials 98