XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Cloudbyz

MAY 11, 2023

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

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Clinical Trials Clinical Trials Trials Compliance 98

Cloudbyz

JANUARY 27, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ Setting up a virtual clinical trial: Things to consider. The pharmaceutical industry has been forced to find new and innovative approaches to try clinical trials. eCOA / ePRO.

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Clinical Trials Clinical Trials Trials Packaging 98

Cloudbyz

OCTOBER 19, 2023

Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident. Cost Efficiency: Centralized data management reduces administrative overhead, minimizing trial costs.

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Clinical Trials Clinical Trials Trials Compliance 104

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 3, 2024

A meta-analysis of relevant studies published in scientific journals found a lack of convincing evidence that CBD – packaged as oils, vapes, creams, gummies, drinks, and more – reduces pain, prompting the team of UK […] Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.

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Production Packaging Packaging Clinical Trials 246

World of DTC Marketing

DECEMBER 29, 2020

These vaccines were developed using different “platform technologies” that involve slotting genetic material from the virus into a tried and tested delivery package. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. However, this is time-consuming.

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Vaccine Vaccination Development Clinical Trials 307

pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”. Tabakin agrees. “In

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Clinical Trials Clinical Trials Trials Development 111

Camargo

OCTOBER 15, 2020

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. If a single-arm trial was conducted as the pivotal trial for regulatory approval of those existing products, the sponsor will certainly want to do the same.

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Production Trials Development Clinical Trials 190

Rethinking Clinical Trials

MARCH 1, 2023

For the investigational ramucirumab plus pembrolizumab arm, the drugs are administered per FDA package insert and institutional standard in a 21-day cycle under one of the criteria for removal is met. One network is the lead, but the trial will be available in all four U.S. verses other immunotherapeutic agents)?

Clinical Trials 100

Clinical Trials Clinical Trials Trials Packaging 100

XTalks

NOVEMBER 6, 2024

The FDA authorization of Valeda was based on clinical evidence from multiple trials, including the LIGHTSITE III study, which demonstrated improved visual acuity and contrast sensitivity in patients treated with Valeda. With the FDA authorization, LumiThera is set to roll out Valeda to clinics across the US in the coming months.

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Manufacturing FDA Approval Packaging Packaging 104

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 12, 2023

Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products.

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Packaging Packaging Pharmacy Pharma Companies 188

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 12, 2024

Despite the availability of medical insurance, the penetration remains meagre with only a few people being able to access the high packages. Indian patient expenses make a strategic shift towards embedded finance access at point-of-care with options to aid out-of-pocket health expenses.

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Packaging Packaging Clinical Trials Clinical Trials 188

Pharmaceutical Technology

JANUARY 20, 2023

While using high-capacity aircraft and minimal packaging reduces weight and increases capacity for vital products by using fewer flights. To learn more about how Tanner is adapting to changes in the clinical trial supply chain and embracing technological innovations, download this white paper.

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Manufacturing Clinical Trials Clinical Trials Production 356

pharmaphorum

SEPTEMBER 7, 2022

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. The post Bridge Bio will use Brainomix AI in lung fibrosis trial appeared first on.

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Trials Clinical Trials Clinical Trials Packaging 128

Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. And accurate labelling and translation are critical for this sector. Regulations can be challenging, with ever-changing rules.

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Medicine Production Packaging Packaging 130

BioPharma Reporter

OCTOBER 5, 2023

Sharp, a commercial pharma packaging and clinical trial supply services firm, has acquired Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish contract development and manufacturing organization (CDMO).

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Manufacturing Pharma Packaging Packaging Packaging 105

ACRP blog

JULY 1, 2024

Diversity action plans—focused on enrolling representative numbers of participants in clinical trials from historically underrepresented racial and ethnic populations—are part of U.S. This is an important part of our commitment to diversity, and to enrolling a diverse body of participants in our clinical trials.”

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

Antidote

JULY 27, 2023

Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials.

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Clinical Research Research Clinical Trials Clinical Trials 98

Imperical Blog

NOVEMBER 28, 2023

Clinical trial labeling is complex. Discover how Imperial CRS helped a client overcome some of the complexities of this critical clinical trial component. Did you know that product labels are big business?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Rethinking Clinical Trials

JULY 18, 2023

Lynn DeBar and Dr. Natalia Morone In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Dr. Lynn DeBar and Dr. Natalia Morone had a conversation about sharing trial results with participant partners. It can also combat misinformation and promote trust. “I think we have that responsibility.”

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Trials Research Packaging Packaging 130

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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Clinical Trials Clinical Trials Trials Biohazard 52

Cloudbyz

MAY 1, 2023

Clinical trial budget management is a complex yet crucial aspect of conducting a successful clinical trial. One of the most challenging tasks for project managers and sponsors is to identify and account for all possible costs, including hidden ones, to ensure that the trial runs smoothly and within budget.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 52

XTalks

JANUARY 29, 2025

This initiative focuses on enhancing infrastructure to support the clinical and commercial-scale final assembly and packaging of drug-device combination products, emphasizing advanced drug delivery systems, particularly injectable formats. Operations at the first phase of the plant are scheduled to begin in Q3 2025.

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Drug Delivery Production Packaging Packaging 52

Rethinking Clinical Trials

NOVEMBER 21, 2022

Pragmatic Clinical Trials. In 2016, we published a pilot trial looking at high-flow nasal cannula (HFNC) therapy compared to CPAP in pediatric critical care. The step-up trial started recruitment in August 2019, 1,449 children were eligible, 600 children were randomized, and 595 consented. ? ? ? ? ? ? ? ? ? ?. Speakers.

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Trials Clinical Trials Clinical Trials Packaging 100

ACRP blog

JULY 1, 2024

Diversity action plans—focused on enrolling representative numbers of participants in clinical trials from historically underrepresented racial and ethnic populations—are part of U.S. This is an important part of our commitment to diversity, and to enrolling a diverse body of participants in our clinical trials.”

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

ACRP blog

JULY 1, 2024

Diversity action plans—focused on enrolling representative numbers of participants in clinical trials from historically underrepresented racial and ethnic populations—are part of U.S. This is an important part of our commitment to diversity, and to enrolling a diverse body of participants in our clinical trials.”

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Cloudbyz

NOVEMBER 12, 2021

This article is the first part of a Cloudbyz series of articles about Recruitment & Retention in clinical trials. There are many challenges to recruitment in the field of clinical trials. Recruiting and retaining participants for clinical trials is in and of itself a generally challenging process.

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Clinical Trials Clinical Trials Trials Packaging 52

Pharmaceutical Technology

MAY 1, 2023

The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. It has been approved to treat ocular itching that is associated with allergic conjunctivitis in the US.

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Licensing Licensing Sales Packaging 162

Pharmaceutical Technology

JUNE 19, 2023

According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone. It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live.

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Gene Therapy Gene Packaging Packaging 130

Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

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Clinical Trials Clinical Trials Trials Regulation 52

Cloudbyz

MAY 24, 2023

The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis. Consumer product clinical trials typically involve the evaluation of new formulations or ingredients for safety, efficacy, and user acceptability.

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Clinical Trials Clinical Trials Production Trials 52

BioTech 365

AUGUST 31, 2021

Bn Clinical Trial Supplies Markets by Services (Manufacturing, Packaging, Logistics, Distribution), Phases (I to IV), Type (Small molecule, Biologics, Medical Devices) – Global Forecast 2026 – ResearchAndMarkets.com $2.9

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Packaging Packaging Clinical Trials Clinical Trials 40

XTalks

AUGUST 18, 2022

Clinical trials are the primary way that researchers find out if a new drug or medical device is safe and effective in humans, so why don’t food and beverage products that make specific health claims go through the same process? Read the full articles here: What are Food Clinical Trials and What Purpose do They Serve?

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Clinical Trials Clinical Trials Trials Packaging 52

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19. Dr. Francis S.

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Clinical Trials Clinical Trials Gene Trials 52

XTalks

SEPTEMBER 3, 2020

Rare disease clinical trials can be particularly challenging when it comes to endpoints. Not only are there typically a limited number of patients that can be included in the trial, but often the endpoints themselves are novel or complex. Clinical Trial Endpoint Development and Quality Control in Data Collection.

Clinical Research 98

Clinical Research Clinical Trials Clinical Trials Research 98

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. Among 20 recent trials, 17 experienced delays in meeting key milestones.

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Clinical Trials Clinical Trials Trials Gene Therapy 52