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

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. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

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.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

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.

Clinical Trials 83

Clinical Trials Clinical Trials Trials Compliance 83

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.

Production 206

Production Packaging Packaging Clinical Trials 206

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.

Clinical Trials 84

Clinical Trials Clinical Trials Trials Compliance 84

ACRP blog

MAY 8, 2024

Nobody ever said that clinical research would be easy. Still, panelists Seneca Harrison, Vice President of Operations and CEO of Quality Research Inc.; Monair McGregor, PhD, MPH, MCHES, Community Engagement Program Manager for SiteBridge Research Inc.; We have to show up and keep on showing up.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Biohazard 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.

Clinical Trials 98

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.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Packaging 130

pharmaphorum

AUGUST 16, 2021

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. The first is a lack of standardisation in trial design, which leads to delays in study setup.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Compliance 98

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.

Packaging 148

Packaging Packaging Clinical Trials Clinical Trials 148

Rethinking Clinical Trials

JULY 18, 2023

An Ethical Obligation DeBar and Morone said they are often surprised by the number of research participants, particularly older patients, who participate in trials based on altruism or with the goal of contributing to advancing science. Stakeholder perspectives may also change over time, so research teams should be flexible.

Trials 130

Trials Research 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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

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

Clinical Trials 111

Clinical Trials Clinical Trials Trials Development 111

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

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

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?”.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

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.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

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. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 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.

Packaging 146

Packaging Packaging Pharmacy Pharma Companies 146

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. This is where the platform approach comes into play.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical 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

ACRP blog

JULY 26, 2023

That’s part of the reason why Sara Abbassi, MBBS, MSPH, a clinical research coordinator (CRC) at Wellnext LLC and ACRP member, says that educating patient advocacy groups about clinical research is a critical component of the profession. This makes sense to me,” Abbassi says.

Clinical Research 98

Clinical Research Clinical Research Coordinator Packaging Packaging 98

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Cloudbyz

JANUARY 13, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ Decentralized Trials will dominate Clinical Research space in 2021. Decentralized clinical trials or DCT have become the new norm for the life sciences industry.

Clinical Research 52

Clinical Research Trials Research Clinical Trials 52

Cloudbyz

JANUARY 20, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ The need for a centralized platform for clinical research study. Clinical research teams are constantly challenged to do more with fewer resources. Resource Management.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? But now it’s a warning in their package insert.

Clinical Research 226

Clinical Research Research Gene Therapy Gene 226

Advarra

DECEMBER 12, 2023

The clinical research industry, like many others, has continued to be challenged by staff turnover in recent years. Clinical research organizations everywhere are seeing an influx of employees leaving their positions to go elsewhere. Understanding this issue is essential to a healthy research organization.

Clinical Research 52

Clinical Research Clinical Trials Clinical Trials Research 52

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.

Vaccination 307

Vaccination Vaccine Development Clinical Trials 307

Cloudbyz

JUNE 1, 2023

Recognizing this, the industry has been leveraging sensory research to understand consumer behaviors better and develop products that appeal to their senses. What is Sensory Research? Methods in Sensory Research Sensory research in the consumer goods industry primarily employs two methodologies: Quantitative and Qualitative techniques.

Research 52

Research Production Packaging Packaging 52

XTalks

JUNE 10, 2022

When it comes to disseminating information, the EPDA has the biggest online library in Europe for information, research and resources for Parkinson’s that are verified by experts. It is a brand-new challenge and brings together my past experiences to help support the Parkinson’s community to engage with research.

Research 98

Research Trials Clinical Trials Clinical Trials 98

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.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Development 40

The Pharma Data

JANUARY 13, 2021

Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

ACRP blog

JULY 26, 2023

That’s part of the reason why Sara Abbassi, MBBS, MSPH, a clinical research coordinator (CRC) at Wellnext LLC and ACRP member, says that educating patient advocacy groups about clinical research is a critical component of the profession. This makes sense to me,” Abbassi says.

Clinical Research 52

Clinical Research Clinical Research Coordinator Packaging Packaging 52