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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Clinical Trials Clinical Trials Trials Clinical Research 105

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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Clinical Research Research Clinical Trials Clinical Trials 52

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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Containment Vaccination Vaccine Clinical Trials 197

pharmaphorum

SEPTEMBER 15, 2022

This enables regulatory reviewers to evaluate and process clinical trials more effectively. full traceability throughout the research process. In this blog, we provide an overview of the CDISC standards used in clinical research. For example, an Adverse Events dataset and the variables it contains.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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

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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Clinical Trials Clinical Trials Trials FDA Approval 98

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 […]

Hormones 186

Hormones Containment Branding Drugs 186

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.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

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. IPs containing engineered genetic materials may pose risks potentially not anticipated by the clinic’s standard infection control policies.

Engineer 52

Engineer Genetics Clinical Research Research 52

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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Containment Sales Marketing Clinical Trials 230

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

pharmaphorum

JANUARY 27, 2023

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. The impact of burnout on clinical trials Each staff member involved in a clinical trial is essential to its success.

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Clinical Trials Clinical Trials Trials Clinical Research 111

pharmaphorum

JANUARY 27, 2023

Clinical trials design and patient input The definition of patient centricity, in fact, and its benefits are now – finally – being defined by patients themselves. “We We talk a lot in clinical trials and drug development about benefit,” Dr Mullen said. But who is benefitting?

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Clinical Trials Clinical Trials Trials Development 110

Advarra

MARCH 10, 2023

SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinical research. Red blood cells contain hemoglobin, a protein that carries oxygen. hindering progress on SCD – there is also a lack of clinical trials and research.

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Clinical Trials Clinical Trials Trials Doctors 98

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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Gene Therapy Gene Trials Clinical Trials 95

Olympian Clinical Research

JUNE 10, 2022

When choosing a soap, read the label and avoid any antibacterial or deodorant soaps that contain irritants, such as fragrances, dyes, or other harsh chemicals. Find a Clinical Trial for Atopic Dermatitis. However, If you are looking for additional relief, you may want to consider enrolling in a clinical trial.

Allergies 98

Allergies Clinical Trials Clinical Trials Clinical Research 98

Camargo

APRIL 28, 2021

The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials. First Steps Toward Initiating Pediatric Clinical Studies.

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Clinical Trials Clinical Trials In-Vivo Drugs 130

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

pharmaphorum

OCTOBER 6, 2021

Formedix has been strong advocates for the use of CDISC data standards in clinical and non-clinical research for decades, ever since we realized how it could transform our business by enabling the rapid design and build of clinical trials. Think of an Adverse Events dataset and the variables it contains.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Trialfacts

MARCH 1, 2023

More Study Details The study team will explain the research in its entirety but please be aware that participation will: Involve blood draws Involve physical examinations, vital signs, and an ECG (An electrocardiogram (ECG or EKG) records the electrical signal from the heart to check for different heart conditions). Locations What’s Next?

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Research Clinical Trials Clinical Trials Containment 52

Crucial Data Soutions

MARCH 30, 2023

With all of the critical data that needs to be collected over the course of a clinical trial, one might assume that all of this data must be collected and managed electronically. EDC, as can be ascertained from the name, involves collecting clinical research data electronically or digitally. Yet, this is not the case.

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Clinical Trials Clinical Trials Trials Research 52

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. associates, residents, research fellows).

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Licensing Licensing Pharmacy Clinical Trials 52

XTalks

JUNE 3, 2022

The tip of the catheter contains sensors that send electrical impulses and can identify the area that is causing the arrhythmia. “We have been using the inHEART solution in clinical research for several years. Clinical Trial of Image-Based 3D Heart Modeling.

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Clinical Trials Clinical Trials Trials Life Science 98

Drug Discovery World

JANUARY 25, 2023

Tom Brazier , Director Decentralised Clinical Trials, mdgroup and Stephanie Larimer, Q² Solutions discuss the opportunities for decentralised clinical trials and how common pitfalls can be avoided through communications and streamlined working. The market, worth an estimated $8.8 billion, by 2026 1.

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Trials Clinical Trials Clinical Trials Nurses 52

pharmaphorum

AUGUST 31, 2021

Many of our innovative life sciences partners pre-socialise their ECA strategy in early discussions with the FDA before finalising the clinical trial to get feedback on the approach from the ultimate decision maker. Myth 3: RWD is too imperfect to be used to as a comparator arm to a clinical trial.

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Clinical Trials Clinical Trials Life Science Trials 78

XTalks

JANUARY 9, 2024

Geneva OS customers gain access to Alexandria, an extensive repository containing tens of thousands of existing studies, including active clinical trial designs. Geneva OS also features the CRAFT (Clinical Research Acceleration for Trials) Emulation Toolkit.

Life Science 59

Life Science Clinical Trials Clinical Trials Trials 59

XTalks

AUGUST 18, 2023

Izervay is the only approved treatment for geographic atrophy that has demonstrated a significant decrease in the rate of geographic atrophy progression at the 12-month primary endpoint, based on results from two rigorous Phase III clinical trials. Izervay contains avacincaptad pegol sodium, an effective complement C5 inhibitor.

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FDA Approval Drugs Clinical Trials Clinical Trials 52

Trialfacts

OCTOBER 24, 2023

About the Research Centre Peninsula Therapeutic And Research Group PTRG is a clinical research centre that specialises in mental health studies. Their team of doctors, nurses, clinical researchers, and administrative staff have 20 years of clinical trial experience.

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Clinical Research Research Nurses Doctors 52

Olympian Clinical Research

NOVEMBER 6, 2023

Moisturize with a lotion or cream containing ceramides, hyaluronic acid, or glycerin. Contribute to Hidradenitis Suppurativa Breakthroughs At Olympian Clinical Research, we’re passionate about making a difference for those with HS. You can contribute to this essential work by participating in our clinical trials.

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Hormones Doctors Doctor Clinical Trials 52

FDA Law Blog

JANUARY 1, 2024

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. Finally, FDA said in a Warning Letter that a Clinical Investigator, Anish S. If FDA wanted to create that impression, it likely succeeded.

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Manufacturing Production Drugs FDA Compliance 59

Trialfacts

NOVEMBER 23, 2022

About the Research Center: Location. Research Center: Parexel. Location: California Clinical Trials Medical Group 1560 East Chevy Chase Drive, Suite 140 Glendale, CA 91206. Lead Researcher: David Han, M.D. Must be able to attend 9-day study visits and 8 night stays at the research site over approximately 56 days.

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Clinical Trials Clinical Trials Hormones Research 52

The Pharma Data

NOVEMBER 10, 2020

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. NEW YORK and LONDON, Nov. We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies.”.

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Life Science Clinical Trials Clinical Trials Trials 40

pharmaphorum

JANUARY 27, 2021

In medical research, trust has traditionally been hard-fought for. Terms like “lab rats” and “guinea pigs” are often used in conversations about clinical trials. The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. Stop hiding from the mistakes of the past.

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Research Clinical Trials Clinical Trials Vaccination 52

Crucial Data Soutions

DECEMBER 15, 2020

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. . These ideas may sound like they’re far down the roadmap to implementation.

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Clinical Trials Clinical Trials Trials Clinical Research 106

pharmaphorum

JANUARY 18, 2023

The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease. The idea of ‘genetic superheroes’ and precision medicine is captivating for researchers, but the concept can be abstract and distant for participants. Giving participants something in return.

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Genetic Disease Genetics Research Genome 95

XTalks

DECEMBER 20, 2023

Novo Nordisk’s GLP-1 weight loss-specific drug Wegovy (semaglutide) has been facing similar shortages, as it contains the same active ingredient as Ozempic. 9. 10 Trends and Statistics for Clinical Trials in 2023 Several key trends in clinical trials have been shaping the landscape of the field this year.

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Life Science Clinical Trials Clinical Trials FDA Approval 59

WCG Clinical

NOVEMBER 20, 2023

The following are some examples of common issues and how to resolve them: The protocol is written in a manner which leads to confusion between research procedures required by the protocol and those that will occur regardless of the research. Access WCG’s whitepaper “Is This an Interventional Clinical Trial or Observational Study?

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Research Clinical Trials Clinical Trials Production 52