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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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. The reasons behind this problem, however, are rarely studied or understood.

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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

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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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 7, 2022

With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution (..)

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 17, 2024

A new drug called kush is wreaking havoc in west Africa, particularly in Sierra Leone where it is estimated to kill around a dozen people each week and hospitalise thousands. The drug, taken mostly by men aged 18 to 25, causes people to fall asleep while walking, to fall over, to bang their heads against […]

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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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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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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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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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Rethinking Clinical Trials

SEPTEMBER 13, 2023

The DEVICE trial hypothesized that the use of a video laryngoscope will increase the incidence of successful intubation on the first attempt. The trial operated under an IRB waiver of informed consent with a patient information sheet. Discussion Themes -Why did the RSI trial follow a different path – not a waiver of consent?

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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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Clinical Trials Clinical Trials Medicine Trials 52

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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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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XTalks

NOVEMBER 29, 2022

Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinical trials at the ACS CAN. Read on to learn more! Over 1,100 cancer patients and cancer survivors responded.

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Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. 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?

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Drug Discovery World

OCTOBER 31, 2023

UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. Following successful engraftment of modified HSCs in the bone marrow, these cells start to produce daughter blood cells which contain the IDS gene and enzyme which are distributed throughout the body, including the brain.

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Gene Therapy Gene Trials Clinical Trials 52

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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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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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. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

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Clinical Trials Clinical Trials Trials Immune Response 52

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

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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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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Clinical Trials Clinical Trials Trials Regulation 52

The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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Clinical Trials Clinical Trials Medicine Trials 52

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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Clinical Research Research Clinical Trials Clinical Trials 52

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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The Pharma Data

OCTOBER 19, 2020

. “We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S.

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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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Rethinking Clinical Trials

DECEMBER 12, 2023

It has been studied in prior contexts in a PCORI trial and a pilot inpatient trial where the intervention increased goals of care discussions from 8% to 21%. Jumpstart is a pragmatic randomized trial of Jumpstart compared to usual care. In some previous trials we have randomized at the clinician level.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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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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The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

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Drug Discovery World

OCTOBER 9, 2023

Positive Phase I trial data indicates that Reqorsa (quaratusugene ozeplasmid) has shown early efficacy for the treatment of non-small cell lung cancer (NSCLC). The data will be presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

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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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Worldwide Clinical Trials

JUNE 15, 2022

The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. We’ve also seen a decrease in available research nurses, as they have had to be reassigned to COVID patients. We need to consider how to use diverse populations in gene therapy trials.

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