VirTrial

NOVEMBER 29, 2023

Clinical trials demand a standardized approach to data collection, especially when it comes to patient-reported outcomes (PRO). In the ever-evolving landscape of mobile technologies, smartphones play a pivotal role in gathering crucial information from clinical trial participants. The mean usability score of 3.7/5

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CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.

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Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders.

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Clinical Trials Clinical Trials Trials Compliance 59

pharmaphorum

AUGUST 6, 2021

Patient enrollment is a common issue across many therapeutic areas in clinical research. Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. These types of studies often highlight problems with patient retention in clinical trials. .

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STAT News

SEPTEMBER 26, 2022

Here’s a scenario anyone who has done clinical research will recognize: A 32-year-old woman participating in a Phase 1 healthy-volunteer crossover clinical trial tested negative for pregnancy when she enrolled and agreed to use contraception during the course of the trial, as specified in the protocol.

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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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Rethinking Clinical Trials

MARCH 23, 2023

The American Journal of Bioethics ( AJOB ) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinical trials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core.

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Crucial Data Soutions

DECEMBER 15, 2020

Someday, clinical and post-market research will be 100 percent remote. But in fact, ‘someday’ in the clinical research space is now. Read on to discover how these concepts are made possible – and practical – today by applying technology to work for rather than against research professionals and patients. .

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccination Vaccine 76

Worldwide Clinical Trials

FEBRUARY 21, 2024

Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 21, 2024

Few would be left untouched by the pathogen were it to gain hold, causing healthcare systems to crumble and economies to collapse as the world once again tried to contain a force of nature. […] With a fatality rate 20 times that of COVID-19, and no vaccine, Disease X could swiftly bring humanity to its knees.

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Drug Discovery World

FEBRUARY 1, 2023

Michael Sassano , CEO at SOMAÍ Pharmaceuticals looks at what’s needed throughout Europe to help increase access to medicinal cannabis and the current state of pharmaceutical research in this area. Despite claims of a whole host of benefits, the clinical studies reality is that there are currently only a few proven indications.

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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.

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Pharmaceutical Technology

SEPTEMBER 20, 2022

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.

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Packaging Packaging Marketing Clinical Trials 100

Drug Discovery World

APRIL 29, 2024

Dr Currien MacDonald, Medical Chair Director at WCG, discusses the challenges and opportunities presented by cannabis research. Research support Support for researching cannabidiol is expanding. More importantly, cannabis research received additional governmental support for continued investigation at the end of 2022 with H.R.8454,

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Medical Xpress

MARCH 20, 2023

Cancer treatment routinely involves taking out lymph nodes near the tumor in case they contain metastatic cancer cells. But new findings from a clinical trial by researchers at UC San Francisco and Gladstone Institutes shows that immunotherapy can activate tumor-fighting T cells in nearby lymph nodes.

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XTalks

NOVEMBER 6, 2020

Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinical trials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinical trial. COVID-19 Clinical Trials.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 25, 2023

The Indian Council of Medical Research (ICMR) has invited Expression of Interest (EoI) through email from experienced Indian agencies for undertaking Transfer of Technology for commercialization and marketing of multiplex single tube real time RT PCR assay for detection of Influenza A , B and SARS CoV2.

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Rethinking Clinical Trials

AUGUST 3, 2023

Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. As researchers, we are producers and consumers of the medical literature. Researchers need to understand how preprints are received.

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Medicine Research Vaccination Vaccine 130

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 17, 2023

The pill, called Opill – the brand name for the tablet formulation of norgestrel – is an oral contraceptive containing only progestin hormone, which helps prevent pregnancy […]

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WCG Clinical

MAY 18, 2023

Princeton, NJ – May 18, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, today released the WCG 2023 Clinical Research Site Challenges Survey Report. based clinical research sites.

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Advarra

FEBRUARY 24, 2023

How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing? Developing the endpoint design and overall approach of a clinical trial program is mostly science, but there is a bit of art to it as well.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 29, 2023

The Drugs Technical Advisory Board (DTAB) has recommended to get comments and inputs from Indian Council of Medical Research (ICMR) for further action on restricting Nicotine Replacement Therapies (NRTs) containing upto 2 mg or 4 mg only through prescription of authorised medical practitioners, as proposed by the Tobacco Control Division (TCD).

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 10, 2022

This means that if someone drinks 50 ml of 40 percent spirits, which contains […]. It is marketed by Swedish firm Myrkl as “the pre-drinking pill that works” The pill is said to break down up to 70 percent of alcohol after 60 minutes.

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Drug Discovery World

JANUARY 11, 2024

Researchers have used messenger RNA (mRNA) to create an effective therapy for a rare liver disease in preclinical studies, demonstrating the technology’s potential therapeutic use in people. mRNA contains instructions that direct the cells to make proteins.

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Pharma Mirror

FEBRUARY 18, 2022

From research to clinical trials, to go-to-market, drug makers are constantly seeking out new drug technologies and approaches to treat everyday illnesses and to end global pandemics. But the vials and containers that deliver these drugs haven’t evolved at nearly the same rate.

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WCG Clinical

JULY 12, 2023

Princeton, NJ, July 12, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, released its 2023 Avoca State of the Industry Report. Avoca joined the WCG family of companies in April 2021. Avoca joined the WCG family of companies in April 2021.

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Drug Discovery World

OCTOBER 27, 2023

Organ-chips combine cell culture with microfluidics to emulate the biological forces of different organ tissues and/or disease states, allowing pharmaceutical researchers to determine a drug candidates’ efficacy and toxicity ahead of clinical trials. Could organ-chips replace other research methods?

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The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. Vaccine manufacturers have previously studied some variant vaccine candidates and are currently conducting clinical trials of Omicron-specific vaccines. Source link: [link].

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Pharmaceutical drug research and development (R&D) activities are capital-intensive, which makes the outsourcing of clinical dose manufacturing and marketing popular. Find the leading clinical dose companies in contract marketing. Prospects of clinical dose companies in contract marketing.

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pharmaphorum

SEPTEMBER 15, 2022

The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to the improvement of medical research through data standardization. This enables regulatory reviewers to evaluate and process clinical trials more effectively. full traceability throughout the research process. increased data quality.

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Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . Sponsors may submit research to be conducted under an IND to an IRB at any time before or after the IND is in effect. The post How the IND 30-day Hold Impacts Clinical Trial Activities appeared first on Advarra.

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Trialfacts

MARCH 1, 2023

Researchers and Actinogen Medical are currently exploring a new potential treatment, Xanamem®, for those with depressive symptoms who are also experiencing cognitive symptoms. If you have been diagnosed with depression and would like to contribute to the development of a potential new treatment, then consider joining this research study!

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Research Clinical Trials Clinical Trials Containment 52

WCG Clinical

NOVEMBER 20, 2023

Why Was My Research Submission/Protocol Deferred? Research submission/protocols are deferred when the Board is unable to determine that the regulatory criteria for approval are met ( 21 CFR§56.111 and 45 CFR§46.111 ). If FDA determines that the research does not need an IND, FDA will issue a statement to that effect.

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Trialfacts

JANUARY 23, 2024

While there is no cure for a peanut allergy, researchers are exploring ways to make the impact of this allergic reaction less severe. Researchers are exploring the potential effects of a new medication because they understand that a peanut allergy is not only dangerous, but it can impact a child’s emotional and mental health as well.

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Pharmaceutical Technology

JUNE 20, 2023

The new AIID building will include a human infection challenge unit, high-containment facilities, a robotic biobanking facility, interview rooms, dry laboratories and spaces for community engagement and co-design work. It will be connected across multiple levels to the University of Melbourne’s Doherty Institute.

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