ACRP blog

SEPTEMBER 11, 2023

Overview Decentralized clinical trials (DCTs) represent the shift towards implementing virtual research studies using digital health tools to gather data and monitor patient activity. Only about 5% of eligible patients enroll in clinical trials, with minority populations representing an even lower percentage. [x]

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Drug Discovery World

JULY 24, 2023

Paul O’Donohoe , Senior Director, eCOA Product and Science at Medidata, looks at the potential of decentralised clinical trials following the Covid-19 pandemic and how the industry will be affected going forward. The role that Covid-19 played in advancing decentralised clinical trials (DCTs) cannot be underestimated.

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Clinical Trials Clinical Trials Trials Contamination 52

Cloudbyz

APRIL 9, 2023

Clinical trial management involves various activities and processes that can have a significant impact on the environment and contribute to sustainability issues. Clinical trials, in particular, have a significant impact on the environment, and it is essential to address this impact to ensure a sustainable future.

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Drug Discovery Today

APRIL 21, 2020

Panthera’s second clinical trial site in the UK, in North Manchester is open for business.As a standalone site ideal for existing or new trials with much lower contamination risk during COVID-19

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Clinical Trials Clinical Trials Contamination Trials 40

Drug Discovery World

MAY 22, 2023

It was recently Clinical Trials Day and DDW have reported on the launch of a number of new Phase I trials. In-human studies have been initiated to test treatments for Parkinson’s disease, radioactive contamination, Dravet Syndrome, influenza and inflammatory diseases.

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Contamination Clinical Trials Clinical Trials Trials 52

Drug Discovery World

MAY 22, 2023

It was recently Clinical Trials Day and DDW have reported on the launch of a number of new Phase I trials. In-human studies have been initiated to test treatments for Parkinson’s disease, radioactive contamination, Dravet Syndrome, influenza and inflammatory diseases.

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Contamination Clinical Trials Clinical Trials Trials 52

pharmaphorum

MARCH 19, 2021

DeepVerge has announced trial data showing its COVID-19 Microtox BT breath test can deliver accurate results in under 60 seconds, with a potential roll-out later this year if further tests support it. A large clinical trial is ongoing in Dubai. A femtogram is 0.000000000000000001 kilograms.

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Contamination Clinical Trials Clinical Trials Protein 145

pharmaphorum

AUGUST 17, 2022

The first lawsuit claiming that gastrointestinal drug Zantac causes cancer has been voluntarily dismissed a week before it was due to come to trial, in an early victory for the pharma companies that will defend themselves from the allegations. The post First Zantac cancer case dropped before trial, without settlement appeared first on.

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Sciensano

MARCH 27, 2024

Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. Although several health authorities warned the public against using this medicine outside clinical trials, the medicine was widely used on a major scale in late 2020 and in 2021.

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Contamination Bacteria Packaging Packaging 52

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Dr. Bahassi: There are several factors to consider when designing a trial that involves ctDNA detection.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

JULY 18, 2023

The drugmaker is facing more than 38,000 talc-related lawsuits, mostly over its iconic baby powder which plaintiffs claim was contaminated with asbestos that caused ovarian cancer and mesothelioma. In the formal complaint, LTL said they have made “careers and small fortunes” testifying for plaintiffs in talc trials.

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Research Contamination Doctors Doctor 95

Imperical Blog

OCTOBER 22, 2020

Health Care and Trials in the Age of COVID-19. Some patients have had clinical trials halt, or even postponed indefinitely, and for far too many patients, especially cancer patients, those clinical trials might well have been a lifeline. CROs Leading Decentralized Trials. Balance, it seems, for some.

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Clinical Trials Clinical Trials Trials Nurses 52

Imperical Blog

OCTOBER 22, 2020

Health Care and Trials in the Age of COVID-19. Some patients have had clinical trials halt, or even postponed indefinitely, and for far too many patients, especially cancer patients, those clinical trials might well have been a lifeline. CROs Leading Decentralized Trials. Balance, it seems, for some.

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Clinical Trials Clinical Trials Trials Nurses 52

JAMA Internal Medicine

MARCH 7, 2021

Yet, these summed findings obscure the inconsistent results of individual clinical trials, which have raised uncertainty and controversy about health benefits. In addition, associated behaviors of individuals who eat fish (eg, other dietary factors and socioeconomic status) could overestimate benefits in observational studies.

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Contamination Clinical Trials Clinical Trials Containment 63

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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pharmaphorum

AUGUST 11, 2022

There are a couple of thousand legal complaints related to Zantac filed in the US, with a class action suit due to go to trial in Illinois later this month, with another scheduled to start in California in October.

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XTalks

JANUARY 4, 2023

We appreciate and thank the burn patients who participated in our trials, the clinical investigators and our researchers for their commitment and efforts to attain this significant achievement.”. “We Clinical Trials of NexoBrid.

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XTalks

JULY 25, 2023

While there is no evidence of person-to-person transmission, anthrax skin lesions may be contagious through direct contact or contaminated objects. The bacteria usually enter the body through wounds, but infection can also occur through contaminated meat or inhalation of spores. Additionally, at Day 64, 86.6

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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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The Pharma Data

DECEMBER 30, 2020

Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy.

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Pharmaceutical Technology

JULY 22, 2022

Peter Hotez’s tweet on PAI Life Sciences’ phase 1 trial of its snail fever vaccine. The phase 1 clinical trial will evaluate the safety and immune response of the vaccine in healthy individuals at the Kaiser Permanente Washington Health Research Institute in Seattle, the article detailed.

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Vaccination Vaccine Life Science Immune Response 130

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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Find Me Cure

MARCH 13, 2020

Second to respiratory droplets (someone coughing or sneezing less than 6 feet away from you), touching contaminated surfaces is the fastest way to spread the virus. . In fact, there are as many as 16 clinical trials already available on our platform ranging in purpose from observation to prevention to treatment. – is a big no-no.

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Clinical Trials Clinical Trials Doctors Doctor 98

XTalks

AUGUST 3, 2021

Concerns of asbestos contamination in Johnson & Johnson’s talc-based formulations have been around since the 1970s, with the company accused of ignoring and failing to report them to the US Food and Drug Administration (FDA). For years, Johnson & Johnson denied the claims.

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XTalks

SEPTEMBER 12, 2022

Related: What are Food Clinical Trials and What Purpose do They Serve? In June, the FDA updated its action levels for lead in baby food and indicated that it would update its action levels for other heavy metal contaminants in the years that follow. Labeling Clarity on Lab-Grown Meat.

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Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies.

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Engineer Genetics Clinical Research Research 52

Cloudbyz

NOVEMBER 9, 2021

If you find out a sample was contaminated at the source, you can alert all relevant personnel within a matter of seconds before confirming they all received the alert in person. Automated alerts can prevent potential major disruptions and control the damage for present ones. Easier Data Matching. Timely eConsent.

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Biobanking Contamination Life Science Packaging 80

Olympian Clinical Research

SEPTEMBER 22, 2022

Fungal nail infections may also spread through contact with contaminated surfaces, such as public showers, pool decks, or locker room floors. Participate in a Clinical Trial on Toenail Fungus at Olympian Clinical Research. In addition, sharing a toenail clipper with someone who has an infection may put you at risk.

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Clinical Research Clinical Trials Clinical Trials Contamination 52

The Pharma Data

AUGUST 21, 2020

Regeneron claims REGN-COV2, which is currently being studied in two Phase 2/3 clinical trials, provides a much-needed treatment option for Covid-19 that has the potential to prevent infection and thus slow down the spread of the pandemic on a global scale. Sign up now.

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Vaccination Vaccine Manufacturing Contamination 52

Rethinking Clinical Trials

NOVEMBER 6, 2023

Cook, PhD Senior Biostatistics Investigator, Kaiser Permanente Washington Health Research Institute Slides Keywords Individually randomized group treatments; Intervention; Randomization; Clinical trials Key Points In individually randomized trials (IRTs), individuals are randomized to either control or intervention arms.

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Trials Clinical Trials Clinical Trials Contamination 130

Drug Discovery World

OCTOBER 5, 2022

It is made as a one-size-fits-all approach, based on huge trials. It’s just a matter of designing hardware properly so that it could be used in a clinical setting without materials, tools, or constructs getting contaminated in the process. various populations, from cells to humans and multiple approvals for various agencies.

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Drugs Regulation Manufacturing Medicine 52

XTalks

MARCH 10, 2022

Mined talc is prone to asbestos contamination because the two minerals are often found together in nature. The unsealed asbestos experiment files were unearthed in two trials last year pertaining to the baby powder. Johnson & Johnson discontinued selling the baby powder in the US and Canada in May 2020 citing a drop in demand.

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The Pharma Data

DECEMBER 28, 2020

With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination.”. The NDA submission was based on the MIST-1 and MIST-2 studies. In these two Phase 3 studies, a fixed combination of micro-dosed phenylephrine 2.5%

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Drugs Production Marketing Contamination 52

Druggist

SEPTEMBER 15, 2020

cm FAST HEALING: ultra-thin hydrocolloid gel provides a moist environment to help reduce scab formation REDUCES CONTAMINATION AND WORSENING: protective barrier against external environment STAYS IN PLACE UP TO 12 HOURS: adhesive, tapered edges so Compeed flexes with movement £6.99 −£1.74 £5.25 Buy on Amazon Price incl.

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Camargo

AUGUST 5, 2021

Prograf was originally approved in 1994 to prevent organ rejection in patients receiving liver transplants, based on the traditional two randomized, open-label, active control trials. In short, the entire regulatory history of tacrolimus until now, spanning 25+ years, has been based on prospective clinical trials.

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XTalks

FEBRUARY 8, 2024

In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing. The efficacy and safety of Rybelsus in reducing blood sugar in patients with type 2 diabetes were investigated in various clinical trials. billion ($657 million). billion in 2022.

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Sales Insulin FDA Approval Drugs 52

Pharmaceutical Technology

MAY 10, 2023

Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant. The LUMOS II II has proven an ideal tool for testing various substances for contamination in pharmaceutical contexts. Particle analysis on a micro-scale is a significant topic in several fields of application.

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