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 85

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Clinical Trials Clinical Trials Trials Packaging 78

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 210

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. Document Management: Stores and manages trial-related documents in a centralized repository.

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Clinical Trials Clinical Trials Trials Compliance 86

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

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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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.

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Clinical Trials Clinical Trials Trials Packaging 52

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

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.

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Clinical Trials Clinical Trials Trials 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

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 151

Cloudbyz

MAY 24, 2023

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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Clinical Trials Clinical Trials Production Trials 52

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

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?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 52

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 105

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 52

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

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.

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Clinical Trials Clinical Trials Gene Trials 52

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 148

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

Outsourcing Pharma

DECEMBER 5, 2022

Experic raises $14m in series B led by Harro Hofilger Packaging Systems and East Seattle Partners as CDMO sees growth in DPI product and clinical trial supply needs.

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Packaging Packaging Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MAY 26, 2023

The submission was supported by a comprehensive analytical and clinical data package, including data from a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trial.

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Pharmaceutical Technology

DECEMBER 12, 2022

Pharmaceutical companies often outsource different parts of the manufacturing process, including the production of small molecule active pharmaceutical ingredients (APIs) and parenteral packaging, to contract manufacturing organizations (CMOs). Regulatory decisions and clinical trial news.

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Manufacturing Drugs Packaging Packaging 147

Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . The post How the IND 30-day Hold Impacts Clinical Trial Activities appeared first on Advarra. Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. .

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Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

MAY 25, 2023

The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. The findings showed that Yuflyma and the reference product were similar in terms of pharmacokinetics, safety, efficacy and immunogenicity after 24 weeks and one year of treatment.

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FDA Approval Packaging Packaging Clinical Trials 130

pharmaphorum

JANUARY 28, 2021

The Covid-19 pandemic has put further pressure on clinical trial suppliers to be fleet of foot in getting products dispatched when a new patient is recruited, as studies for vaccines have been set up and run at unprecedented speed. . To find out more about the webinar and to register, visit [link] .

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Packaging Packaging Clinical Trials Clinical Trials 52

Crucial Data Soutions

JUNE 16, 2022

While there are numerous clinical trial management platforms on the market, only a small portion allow study leaders to configure things to suit their specific needs. The post Low-Code or No-Code Software to Manage Clinical Trials – Tools to Build Your Studies, Quickly appeared first on Crucial Data Solutions.

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Clinical Trials Clinical Trials Trials Development 40

ACRP blog

JULY 26, 2023

But it’s not just about study design—educating patient advocacy groups about clinical research can also help to increase public awareness of the importance of clinical trials.” That session is available as part of a Regulatory & Compliance replay package of conference sessions or in the Full Program replay package.]

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Clinical Research Clinical Research Coordinator Packaging Packaging 98

The Pharma Data

JANUARY 13, 2021

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

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Clinical Trials Clinical Trials Development Trials 52

Rethinking Clinical Trials

NOVEMBER 21, 2022

Pragmatic Clinical Trials. The team was also able to generate some pilot data on outcomes such as reintubation rate and length of respiratory support to try and understand how we could take this forward in a trial. ? ? ? ? ? ? ? ? ? ?. Speakers. Padmanabhan Ramnarayan, MBBS, MD, FRCPCH, FFICM. Reader in Pediatric Critical Care.

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Trials Clinical Trials Clinical Trials Packaging 130

ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

ACRP blog

AUGUST 1, 2023

Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the Association of Clinical Research Professionals (ACRP) to the U.S.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Sciensano

MARCH 27, 2024

In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day. It is also being promoted as a low-cost medicine via social media, but there is no clinical evidence to confirm that ivermectin is an effective treatment of COVID -19.

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Contamination Bacteria Packaging Packaging 52

Pharmaceutical Technology

NOVEMBER 24, 2022

Additionally, the transfer of technology will build and validate capacity for scaling up Good Manufacturing Process (GMP), domestic production of clinical trial products and end-to-end vaccine manufacturing in Africa for regional and global use.

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Vaccination Vaccine Development Manufacturing 147

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

Cloudbyz

JUNE 21, 2023

In the world of clinical research, Electronic Data Capture (EDC) systems play a pivotal role in efficiently collecting, managing, and analyzing clinical trial data. The Study Data Tabulation Model (SDTM) is a widely accepted format that ensures consistency and interoperability of clinical trial data.

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Clinical Trials Clinical Trials Compliance Trials 68