Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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Clinical Research Research Clinical Trials Clinical Trials 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

Pharmaceutical Technology

NOVEMBER 30, 2022

Development of vaccines to Phase I trials under the five-year $59m prototype project comprises additional $28.4m Additionally, the funds are intended to advance the vaccines to successful conclusion of Phase I clinical trials. in milestone payments.

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Vaccine Vaccination Development Gene Therapy 147

XTalks

SEPTEMBER 5, 2024

HistoSonics announced the results of its pivotal #HOPE4LIVER trials, showcasing the Edison Histotripsy System’s effectiveness in non-invasively destroying liver tumors. The trials, published in Radiology , involved 44 patients and 49 tumors — ranging from primary liver cancers to metastatic tumors.

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Trials Radiology Compliance Production 52

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?

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Trials Drug Delivery Drugs Gene 83

pharmaphorum

SEPTEMBER 14, 2021

In the European hospital setting, the first to digitise were the picture archiving systems (PACS) in radiology departments then electronic medical records (EMRs), patient administration systems and departmental IT flow work solutions (eg, laboratory information systems and radiology information systems).

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Radiology Clinical Trials Clinical Trials Pharmacy 135

Worldwide Clinical Trials

JULY 8, 2024

How to Minimize Radiation Exposure To minimize radiation exposure and its potential risks trial participation, here are several precautions: Patient Screening and Assessment : Before enrolling a patient, investigators should evaluate the patient’s medical history and current health status to ensure the procedure is appropriate and safe.

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Hormones Regulation Clinical Trials Clinical Trials 130

Worldwide Clinical Trials

MAY 24, 2022

Join us as we celebrate cancer research awareness month and clinical trials awareness month. What I like about my role at Worldwide Clinical Trials is that feeling that I am close to the patient, as I am often involved in confirming the patient’s eligibility on the study, understanding how patients are responding to the drug.

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Clinical Trials Clinical Trials Research Trials 130

The Pharma Data

MARCH 22, 2021

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo. The specific search for CVST found no events in this trial.

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Trials Vaccine Vaccination Radiology 52

pharmaphorum

SEPTEMBER 22, 2021

. “The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives,” said Tim Stenzel, director of the FDA’s office of in vitro diagnostics and radiological health.

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In-Vitro Radiology Regulation Trials 108

pharmaphorum

JANUARY 24, 2022

Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.

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Radiology Marketing Genome Genomics 111

pharmaphorum

JANUARY 17, 2023

Greater Manchester has been selected as the site for the trial, as rates of lung cancer there are among the highest in the UK, said the partners. qXR has been trained on more than 2 million X-rays and their corresponding radiology reports, using deep-learning algorithms to interpret the images. The pilot will run for six months.

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Radiology Pharma Companies Trials Marketing 110

XTalks

MARCH 27, 2023

The first line of treatment for invasive candidiasis is a subset of antifungal medications called echinocandins, which includes caspofungin (brand name Cancidas), the drug that rezafungin was compared with in clinical trials. Once the fungus cannot synthesize β-(1, 3)-D-glucan, it undergoes osmotic instability and cell death.

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Clinical Trials Clinical Trials Branding Trials 98

pharmaphorum

DECEMBER 15, 2022

The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world. It cites data estimating there is ten-fold higher demand for radiology services than available capacity, with around half of practitioners “experiencing depression or burnout” due to “unmanageable caseloads.”

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Radiology FDA Approval Licensing Licensing 59

XTalks

SEPTEMBER 9, 2022

The SAINT Neuromodulation Trial. The results of the double-blinded randomized controlled trial (RCT) that assessed the SAINT technology for treating depression were published in October 2021 in the American Journal of Psychiatry.

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Radiology Life Science Licensing Licensing 98

The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

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Trials Antibody In-Vitro Medicine 52

WCG Clinical

SEPTEMBER 23, 2024

However, growing numbers of clinical trials are now using both diameter and volumetric measurements to assess treatment response, with the two kinds of measurements at times producing strikingly different results. In addition, we are now introducing metabolic and functional information from molecular imaging methods. guidelines.

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Clinical Trials Clinical Trials Trials Radiology 52

pharmaphorum

SEPTEMBER 2, 2021

The analysis of a dozen studies of AI-powered image recognition software for breast cancer screening – published in the British Medical Journal – has found that the technology isn’t yet reliable enough to replace radiology specialists.

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Radiology Research Trials 98

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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Trials Antibody Vaccination Vaccine 52

The Pharma Data

OCTOBER 12, 2021

Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.

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Trials Development Antibody Radiology 52

The Pharma Data

DECEMBER 14, 2020

The Phase II SBIR grant is a follow-on 2–year award that will support testing of Alume’s fluorescent nerve targeting agent in an ongoing Phase 1/2 clinical trial in patients undergoing Head and Neck Surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Radiology 52

WCG Clinical

SEPTEMBER 13, 2024

Given the societal impact, there is a significant amount of clinical trial work being performed to evaluate traumatic brain injury. Today, there are over 400 ongoing clinical trials. Depending on the clinical presentation of the patient, a radiologic evaluation to detect intracranial injury is performed.

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Clinical Trials Clinical Trials Trials Radiology 52

XTalks

JUNE 30, 2023

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, head of Radiology Research and Development at Bayer, in the company’s news release. “We What is Contrast-Enhanced Mammography (CEM)?

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FDA Approval Radiology Trials Life Science 98

FDA Law Blog

JULY 17, 2024

Peter Marks and Patrizia Cavazzoni, spans across both Centers, and will collaborate with the Center for Devices and Radiological Health, Oncology Center of Excellence, Office of Orphan Products Development, and Office of Combination Products. Early Direction for the Rare Disease Innovation Hub The Hub, which will be co-chaired by Drs.

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The Pharma Data

NOVEMBER 18, 2021

Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset.

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Trials Antibody In-Vitro Vaccine 52

Delveinsight

DECEMBER 29, 2020

Audentes Therapeutics’ ASPIRO Trial Free to Proceed. The Food and Drug Administration (FDA) decided to lift the clinical ban from Audentes Therapeutics’ ASPIRO trial, which was aimed at investigating its AT132 for the treatment of X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease. . The post A USD 4.2

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Trials Drugs Hormones Radiology 52

Scienmag

FEBRUARY 16, 2021

Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) will participate in this “collaborative community” A medical “collaboratory” is a forum in which multidisciplinary private and public sector members work together on medical […].

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Radiology Drugs Clinical Trials Clinical Trials 48

The Pharma Data

FEBRUARY 21, 2022

Our leadership in cardiology, radiology and women’s health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division.

Radiology 52

Radiology Cardiology Development Production 52

Scienmag

SEPTEMBER 18, 2020

ARRS promises to deliver the same clinically relevant experience for which its Annual Meeting has long been heralded: world-class educational activities led by the field’s foremost experts that span every subspecialty of radiology Leesburg, VA, September 18, 2020–The American Roentgen Ray Society (ARRS) will convene its 2021 Annual Meeting (..)

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Radiology Clinical Trials Clinical Trials Gerontology 47

pharmaphorum

OCTOBER 5, 2022

It includes for a phase 2 pre-exposure prophylaxis trial, to begin this second half of the year, with initial data expected by mid-2023. Currently, there is a significant unmet need to address shortcomings in preventative and therapeutic options for influenza, the efficacy of the present options that do exist ranging from only 10% to 60%.

Antibody 110

Antibody In-Vitro Radiology Development 110

XTalks

NOVEMBER 29, 2022

The study results will be presented at the Radiological Society of North America annual meeting , which is currently being held in Chicago, IL until December 1, 2022. XTALKS WEBINAR: Getting Neuroimaging Right — How to Succeed in Neurodegenerative Clinical Trials. What is ADHD and How is it Diagnosed?

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Development Radiology Clinical Trials Clinical Trials 97

The Pharma Data

MARCH 24, 2021

Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021. The NIAID-supported COVID-19 Prevention Network (CoVPN) participated in the trial. D8110C00001 1.

Vaccine 52

Vaccine Vaccination Radiology Trials 52

XTalks

APRIL 27, 2021

Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a statement from the agency. This included data from an unblinded study of 40 stroke patients over a 12-week trial.

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Radiology Development FDA Approval Containment 105

The Pharma Data

MAY 16, 2021

The Phase 3 trial is expected to enrol more than 35,000 adult participants from a broad range of countries and will assess the efficacy of two vaccine formulations including the D614 (Wuhan) and B.1.351 1.351 (South African) variants. Department of Health and Human Services in collaboration with the U.S. About the GSK / Sanofi partnership.

Immune Response 52

Immune Response Vaccine Vaccination Trials 52

Cloudbyz

JULY 31, 2024

A Delegation of Authority log (DOA) does just that – it lists the qualified individuals to whom the PI has delegated significant trial-related duties. Although the PI may delegate tasks, they retain ultimate responsibility for the overall conduct of the trial. The DOA only suffices the first part of our initial responsibility.

Compliance 52

Compliance Trials Clinical Trials Clinical Trials 52

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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Clinical Trials Clinical Trials Insulin Radiology 59

The Pharma Data

JANUARY 27, 2021

The good news is that, more recently, “our ongoing surveillance and research suggests that there has been a rebound in [cancer] trial launches,” Lamont said. “This study speaks to a big decline in the launch of new trials during the pandemic,” Schilsky noted. “Some trials never resumed and may never.

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Research Trials Radiology Scientist 52