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

Packaging 40

Packaging Packaging Clinical Trials Clinical Trials 40

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 152

Packaging Packaging Clinical Trials Clinical Trials 152

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).

Manufacturing 105

Manufacturing Pharma Packaging Packaging Packaging 105

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.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

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

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.

Trials 127

Trials Clinical Trials Clinical Trials Packaging 127

ACRP blog

MAY 8, 2024

We have to be sure we are bringing the right message—delivered in the right package—[to audiences of potential trial participants]. …We Author: Gary Cramer The post ACRP 2024 Expert Panelists Tackle Top Concerns and Opportunities for Better Clinical Trial Conduct appeared first on ACRP.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

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.

Clinical Trials 84

Clinical Trials Clinical Trials Trials Compliance 84

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

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. Key Points.

Trials 130

Trials Clinical Trials Clinical Trials Packaging 130

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.

Clinical Research 98

Clinical Research Research Clinical Trials Clinical Trials 98

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 FDA’s current thinking on the use of single-arm trials?

Production 190

Production Trials Development Clinical Trials 190

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.

Gene Therapy 130

Gene Therapy Gene Packaging Packaging 130

BioSpace

SEPTEMBER 21, 2020

Competition for resources is growing, and the usual supply chain partners may not have available capacity in the preferred timeframe.

Packaging 97

Packaging Packaging Trials 97

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

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. Resource Management. Study Start-up.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Packaging 98

Pharma Mirror

FEBRUARY 6, 2024

By Barbara Arone, Vice President, Real World Solutions, IQVIA The use of real-world evidence (RWE) in the development of pharmaceutical treatments has grown exponentially in the past 10 years, fueled by availability of higher quality data, trial competitiveness and growing investments in personalized and rare disease treatments.

Production 100

Production Packaging Packaging Clinical Research 100

Pharmaceutical Technology

APRIL 3, 2023

The company conducted a Phase I pharmacokinetics (PK) bridging trial as part of the comprehensive submission package to the EMA. This trial compared the approved adalimumab 50mg/mL 2 with the 100 mg/mL HCF.

Marketing 264

Marketing Medicine Packaging Packaging 264

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

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 130

Clinical Trials Clinical Trials Trials Packaging 130

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 149

Packaging Packaging Pharmacy Pharma Companies 149

VirTrial

DECEMBER 4, 2023

In the fast-paced world of clinical research, Randomization and Trial Supply Management (RTSM) systems play a pivotal role in ensuring the success of trials. Late integration of RTSM means it inherits decisions made upstream in the trial process.

Trials 52

Trials Clinical Trials Clinical Trials Clinical Research 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

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

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

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.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

Cloudbyz

MARCH 30, 2023

However, the development and delivery of cell and gene therapies present significant operational challenges that must be navigated carefully to ensure successful clinical trials. Cost: Manufacturing cell and gene therapies can be expensive, especially for small patient populations, which can impact the overall viability of a trial.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 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. One way is email campaigns.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Packaging 52

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.

Packaging 98

Packaging Packaging Production Development 98

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.

Licensing 162

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.

Packaging 52

Packaging Packaging Clinical Trials Clinical Trials 52

pharmaphorum

APRIL 16, 2021

Activist investor Elliott Management has built a significant stake in GlaxoSmithKline, after a poor run of clinical trial results this year raised questions about management’s strategy to turn around the company’s fortunes. But that failed in a late-stage lung cancer trial comparing it with Keytruda in January.

Trials 69

Trials Sales Packaging Packaging 69

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.

Marketing 130

Marketing Packaging Packaging Medicine 130

pharmaphorum

APRIL 11, 2022

Chris Garabedian, CEO of Xontogeny, describes how his past experiences as CEO of Sarepta Therapeutics have led him on an exploration for technology that can effectively leverage wearable data in clinical trials. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Development 111

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.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52