Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Pharma Mirror

FEBRUARY 6, 2024

It has transformed from a “nice-to-have” into a “must-have” part of the evidence package, helping to contextualize clinical research and improve treatment understanding. In addition to utilizing RWE in clinical research, there is a growing trend toward implementing RWE early in the product development lifecycle.

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Roots Analysis

AUGUST 26, 2024

In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

Two single-country trials and 44 multinational investigations with a site in Ukraine have started over the past six months, according to Global Data, with research covering infectious diseases, cardiology, schizophrenia, and gastrointestinal therapies. A clear path exists for clinical research to continue, with the potential to scale.

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XTalks

APRIL 24, 2023

The natural mold inhibitor is just the latest in Corbion’s wide range of offerings, which include food innovations, specialty ingredients and packaging products. Related: Is Fiber Based Packaging the Next Trend in Sustainable Food Packaging? Here’s everything you need to know about this burgeoning food industry innovator.

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Camargo

JANUARY 12, 2022

While this type of meeting was previously limited to discussions of products regulated by the Center for Biologics Evaluation and Research (CBER), INTERACT meetings will also encompass those regulated by the Center for Drugs Evaluation and Research (CDER) under PDUFA VII. Receipt of Background Package.

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XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. Related: Are Best Before Dates on Food Packaging to Blame for Food Waste? According to a recent report from The Business Research Company, the global organic food market is projected to reach $294.54

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Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Remember, only those questions listed in the package will be discussed during the INTERACT meeting.

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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. So probably the biggest change for us on our packaging labels is we have to redo all that and add sesame.”.

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World of DTC Marketing

AUGUST 7, 2022

Andrew Witty, its CEO, had a 2021 pay package worth $18.4 Researchers with Aimed Alliance , a non-profit that seeks to protect and enhance the rights of health care consumers and providers, say that doctors are so fed up with the constant headaches caused by insurers that two-thirds would recommend against pursuing a career in medicine.

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Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. What is the top regulatory concern when a single-arm study is employed? Simply, BIAS.

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Pharmaceutical Technology

NOVEMBER 21, 2022

However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).

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Pharmaceutical Technology

MARCH 10, 2023

Freeze-drying systems companies help in the verification and validation monitoring of the freeze-drying process to comply with the latest regulations and good automated manufacturing practice (GAMP) guidelines.

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Cloudbyz

MARCH 3, 2023

Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. This can make it challenging to ensure compliance with the latest regulations and guidelines.

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pharmaphorum

NOVEMBER 26, 2020

He told Sky News that additional costs, bureaucracy and delays could follow a no-deal Brexit, or an agreement failing to address the complexity of drug regulation. As companies begin to seek approval from the regulator for new COVID-19 vaccines, it’s critical that we get the roll out right.

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Pharmaceutical Technology

AUGUST 30, 2022

Oswaldo Cruz Foundation will package the drug in its facility in Rio de Janeiro before supplying it to the Brazilian public health system; the company is also involved in clinical trials for the drug’s possible use as Covid-19 prophylaxis. Local production of Sputnik V in Brazil was started in January 2021.

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XTalks

SEPTEMBER 22, 2020

MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. The Velco-like device pierces the packaging and the food via silk microneedles that suck in material through capillary action.

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XTalks

AUGUST 31, 2020

Importation of contaminated food and food packaging is a feasible source for such outbreaks and a source of clusters within existing outbreaks,” according to the study’s abstract. The study counters a World Health Organization statement from August 13 that reported food or food packaging had not been linked to the transmission of COVID-19.

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XTalks

JULY 26, 2024

Plastics are ubiquitous in consumer and industrial products, ranging from packaging to automotive parts. Despite concerns, current evidence does not show significant migration of these particles from plastic food packaging into foods and beverages. Understanding their presence and potential impacts is crucial for industry stakeholders.

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Cloudbyz

JANUARY 27, 2021

For the last many years, although the virtual trial has found its popularity, sponsors and researchers have always been hesitant to embrace it wholeheartedly for many reasons. Technologies like artificial intelligence and clouds are used heavily to seamlessly flow electronic data from the patient to hospitals and research centers.

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XTalks

JULY 11, 2024

They help regulate muscle contractions, including the heartbeat and are vital for nerve function. GoodSport Nutrition’s products are designed to deliver hydration effectively, backed by scientific research. As more people recognize the benefits of these nutrients, the popularity of electrolyte beverages has surged.

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Pharmaceutical Technology

FEBRUARY 3, 2023

Researchers have relentlessly worked through the barriers to create lifechanging treatments for patients in need. “As For example, researchers have developed a two-plasmid cotransfection system. Another immediate benefit is improved batch-to-batch consistency — something regulators are expected to tighten the rules on in coming years.

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XTalks

MAY 9, 2023

If you’re considering a career in clinical research, read on to learn more about this rewarding career. A clinical trial manager is responsible for overseeing the planning, conduction and completion of clinical trials in accordance with applicable regulations, guidelines and protocols. What Does a Clinical Trial Manager Do?

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Pharmaceutical Technology

NOVEMBER 21, 2022

However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).

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XTalks

APRIL 14, 2021

New research published in Science Advances has suggested that a natural cyan blue extracted from red cabbage could replace synthetic blue dyes in food. Food coloring is an essential part of the food and beverage industry; however, some research suggests that using synthetic dyes is not healthy for the consumer. 1, FD&C Blue No.

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pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

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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.

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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.

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Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Improved Scalability As research organizations grow, so do their needs.

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The Pharma Data

MAY 17, 2021

In a separate Research Letter, Simon J. Gunter, MPhil, and his colleagues at the PORTAL research group provides an analysis of the effect of market exclusivity of drugs under FDA’s Unapproved Drug Initiative (UDI).

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Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. While Part 11 is widely known, this blog explains how it fits in with your research software. In 1997, FDA released regulations providing guidance on the use of electronic systems.

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XTalks

NOVEMBER 9, 2022

Since highly processed foods have become more prevalent in recent decades, researchers are still working to understand the full impact of these dietary shifts. Researchers found that the consumption of such foods may be the attributable cause of death in a significant percentage of deaths in the Brazilian population. .

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XTalks

JULY 19, 2024

The term “daily value” is central to understanding the Nutrition Facts label, a staple on nearly every packaged food product in the US since 1994. These entities conduct research on consumer habits and food consumption data to set realistic serving sizes. Packaging also plays a role.

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Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Quality control release testing.

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XTalks

AUGUST 12, 2020

A pool of over 1,000 US consumers asked to identify the healthier options based on whole grain content made the wrong choice 47 percent of the time for bread, up to 37 percent for crackers and 31 percent for cereal, the researchers said. Related: Move Over Nutrition Labels, Carbon Footprint Labels are Coming to a Snack Near You.

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XTalks

MARCH 23, 2022

According to a new survey from consumer research platform Attest , 60 percent of US consumers are actively seeking food and beverage products to support their overall health. As part of its research, Attest showed participants six varieties of granola bars and asked them to identify which was the healthiest choice.

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pharmaphorum

FEBRUARY 12, 2021

Growth in the biologics space is particularly strong due to the Irish government’s investment in the National Institute for Bioprocessing Research & Training (NIBRT), based at University College Dublin. It is a recognised part of our economy and we are very welcoming and open to foreign investment”.

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