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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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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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. About Alume Biosciences, Inc. To learn more about Alume, visit www.alumebiosciences.com.

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Clinical Trials Clinical Trials Trials Radiology 52

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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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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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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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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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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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

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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.

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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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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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WCG Clinical

MARCH 17, 2023

With many clinical research sites facing study start-up delays and backlogs, performing a coverage analysis efficiently and thoroughly is critical to the study start-up process. But why is the coverage analysis process so vital for clinical trials and how can research sites do it more effectively?

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Compliance Clinical Trials Clinical Trials Trials 52

pharmaphorum

JUNE 18, 2021

The Compliant Component Builder platform has already been put through its paces at AstraZeneca, which used it to build a new component to incorporate into one of its existing digital health tools, used for remote monitoring of patients in clinical trials. The algorithms used in healthcare are becoming more complex as well.

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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.

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XTalks

JANUARY 26, 2024

Clinical trials have demonstrated the potential of CRISPR/Cas9 in this field. Personalized medicine: One of the most exciting prospects of CRISPR/Cas9 in oncology is its contribution to personalized medicine. By tailoring treatments based on an individual’s genetic makeup, it may allow for more effective and targeted therapies.

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Cloudbyz

APRIL 4, 2023

Source documents and case report forms (CRFs) are two types of documents that are commonly used in clinical trials to collect clinical data. However, the manual extraction of relevant clinical data from these documents can be time-consuming and error-prone.

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Clinical Trials Clinical Trials Containment Radiology 52

Cloudbyz

JULY 31, 2024

Real-World Evidence Generation: Diagnostics contribute to the collection of real-world evidence (RWE), providing valuable data on how treatments perform in diverse patient populations outside the controlled environment of clinical trials. This information is critical for refining treatment protocols and improving patient outcomes.

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Gene Therapy Gene Medicine In-Vitro 52

Triage Cancer

OCTOBER 15, 2020

In some cases, participating in a clinical trial may or may not be covered by a pharmaceutical company. It is important to bring actual disc images of any CT, PET or MRI scans that you have had as well as their corresponding radiology reports to your appointment. Clinical Trial Participation.

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Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Remember, some staff may not need protocol-specific training.

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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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The Pharma Data

DECEMBER 23, 2020

Additionally, Phase 1 clinical data found INO-4800 to have a favorable safety and tolerability profile with no serious adverse events reported; only six Grade 1 adverse events (AEs) were observed, primarily minor injection site reactions. ” Findings from the Phase 1 Clinical Trial. mg and 2.0

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XTalks

FEBRUARY 10, 2021

Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said Malvina Eydelman, MD, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health, in a FDA news release. How it Works.

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The Pharma Data

OCTOBER 22, 2020

reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. The incidence of adverse events associated with Veklury was similar to placebo in the ACTT-1 trial. to 2.48; p=0.017).

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The Pharma Data

OCTOBER 1, 2021

Bayer published today the results of its LEADER-75 (LowEr Administered Dose with highEr Relaxivity) study, demonstrating the clinical efficacy of a reduced dose of gadobutrol compared to a typical dose of gadoterate in patients undergoing a steady-state contrast-enhanced MRI of the CNS. mmol/kg) for CNS imaging. mmol/kg weight. “At

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pharmaphorum

SEPTEMBER 30, 2022

First and most obviously is the detailed data from the Clarity AD study reported this week, which will be revealed at the Clinical Trials on Alzheimer’s Congress (CTAD) in November. There will still be much debate about the exact license granted to the drug and cost-effectiveness deliberations, according to Prof Passmore.

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Clinical Trials Clinical Trials Sales Drugs 52

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022.

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FDA Law Blog

FEBRUARY 28, 2022

Hearing from patients at the outset can help lead to better clinical trial designs, expedited patient recruitment, and ultimately greater acceptance of new medical devices! Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance. The FDA webinar information can be found here.

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The Pharma Data

OCTOBER 14, 2020

He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology. Dr. Felker’s research focus is on clinical trials in acute and chronic heart failure and the use of biomarkers as diagnostics, prognostic, and therapeutic tools in heart failure.

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Cardiology Clinical Trials Clinical Trials Medicine 40

The Pharma Data

AUGUST 15, 2021

The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC. The major efficacy endpoint for the treatment of VHL-associated RCC was ORR measured by radiology assessment using RECIST v1.1 WELIREG is the first HIF-2?

Hormones 52

Hormones Clinical Trials Clinical Trials 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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XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. The company reported an investment of $2.7

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Intouch Solutions

SEPTEMBER 27, 2024

At one of the presidential symposia, a standout study discussed the Phase III POD1UM-303 trial, which demonstrated that adding retifanlimab to standard chemotherapy significantly improved progression-free survival for patients with unresectable, locally recurrent or metastatic squamous cell carcinoma of the anal canal.

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DNA Trials Antibody Marketing 59

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. guidelines.

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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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Radiology 52

pharmaphorum

AUGUST 9, 2022

The software is combined with traditional MRI scanning to improve the “accuracy and speed” of prostate cancer diagnosis by improving the diagnostic resolution of images, according to the company, which makes it available as a software-as-a-service (SaaS) to radiology departments.

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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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