Pharmaceutical Technology

MAY 7, 2023

The homogeneous nanosuspension looks like a solution that provides improved comfort to the eyes and helps drug penetrate well into ocular tissues. The trials met their primary endpoints by generating fast and sustained clearance of ocular inflammation and ocular pain relief that were statistically and clinically better than placebo.

Trials 130

Trials Drugs Development 130

Clinical Trial Podcast

JULY 31, 2022

In this episode, I’m excited to talk about medical imaging in clinical trials. . We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more.

Clinical Trials 122

Clinical Trials Clinical Trials Trials Clinical Research 122

WCG Clinical

OCTOBER 9, 2023

Sponsors must innovate in ways that increase endpoint predictability without adding to the burden on sites. This helps ensure sponsors and investigators have the data-driven insights to inform study design and protect clinical endpoints. Clinical photography allows raters to accurately assess change over time.

Dermatology 59

Dermatology Trials Marketing Clinical Trials 59

Outsourcing Pharma

APRIL 27, 2021

The combination of companies brings together ERTâs clinical endpoint data capabilities and Bioclinicaâs imaging, eClinical and drug-safety solutions.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

VirTrial

JANUARY 2, 2024

While we’re constantly publishing content on the latest science and trends in clinical research, we took a moment to reflect on what resonated with you the most in 2023. They also often rely on CROs to recommend eClinical solutions that can help meet critical milestones on time. Happy New Year!

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

WCG Clinical

APRIL 28, 2023

WCG-Webinar-Slides-Improving-Research-Billing-Outcomes Download Does your coverage analysis align with the operational realities of billing for clinical trial services? Speak With Our Experts Contact Us The post Improving Research Billing Outcomes: The Real Impact of Coverage Analysis Choices appeared first on WCG Clinical.

Research 52

Research Clinical Trials Clinical Trials Clinical Research 52

Drug Discovery World

NOVEMBER 2, 2022

Norstella and Citeline (formerly Pharma Intelligence) have merged to form a $5 billion global company, one of the largest pharma intelligence solutions providers on the market. . Norstella now has more than 1,500 employees across its five brands: Evaluate , MMIT , Panalgo , The Dedham Group , and Citeline. . “We

Clinical Trials 52

Clinical Trials Clinical Trials Branding Trials 52

pharmaphorum

NOVEMBER 20, 2022

In addition, it offered the opportunity for new solutions and approaches to many of today’s healthcare challenges. Moving at lightning speed meant the scope and timelines of COVID-19 clinical studies were compressed, necessitating stringent quality levels and relying on valued expertise.

Vaccination 96

Vaccination Vaccine Development Clinical Development 96

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. New sensor technology revolutionising data collection.

Clinical Trials 89

Clinical Trials Clinical Trials Trials Regulation 89

Drug Discovery World

SEPTEMBER 8, 2022

The data will be used to explore the efficacy of BBT-877 and to demonstrate the value that Brainomix AI-powered imaging biomarkers offer as new endpoints for future IPF clinical trials. The post Phase II IPF trial to benefit from AI imaging appeared first on Drug Discovery World (DDW).

Trials 52

Trials Clinical Trials Clinical Trials Development 52

BioTech 365

OCTOBER 14, 2020

Next generation eCOA device with integrated respiratory assessment Vitalograph are delighted to announce that their most powerful ever In2itive e-Diary is now available for global clinical trials, offering the ideal solution for respiratory endpoint studies. The new In2itiveTM e-Diary is … Continue reading →

Clinical Trials 52

Clinical Trials Clinical Trials Trials 52

XTalks

JUNE 3, 2022

A new 3D heart modeling solution by inHEART received FDA 510(k) clearance. The modeling solution allows for 3D visualization and analysis of the heart for pre-procedural planning and intraprocedural use. “We have been using the inHEART solution in clinical research for several years. Photo courtesy of inHEART.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

XTalks

JANUARY 9, 2024

Atropos Health, known for its approach to converting real-world clinical data into personalized healthcare evidence and insights, has collaborated with Arcadia, a healthcare data platform specialist. Geneva OS also features the CRAFT (Clinical Research Acceleration for Trials) Emulation Toolkit.

Life Science 59

Life Science Clinical Trials Clinical Trials Trials 59

XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. The COVID-19 pandemic certainly has pushed to the forefront of clinical trials, the digital evolution in clinical research. What are Decentralized and Hybrid Clinical Trials?

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

MARCH 19, 2024

Additionally, traditional clinical studies fail to objectively assess cognitive function as part of patient eligibility criteria or stratify patients according to the presence or degree of cognitive impairment. Milanovic during this interview are hers individually and do not necessarily reflect the views of Sumitomo Pharma America.

Drugs 115

Drugs Clinical Trials Clinical Trials Clinical Research 115

pharmaphorum

DECEMBER 13, 2022

Over the past few years, many clinical study administrators wanted to use the bring your own device (BYOD) model within their eCOA, but they were typically constrained by regulatory requirements or misunderstandings around the approach. BYOD in clinical trials. Statistics show there are 6.5 billion smartphone users globally in 2022.

Clinical Trials 58

Clinical Trials Clinical Trials Compliance Trials 58

ACRP blog

SEPTEMBER 27, 2023

Food and Drug Administration’s (FDA’s) Rare Disease Endpoint Advancement (RDEA) Pilot Program , the clinical research enterprise gains new support for efforts aimed at efficacy endpoint (or clinical outcome) development and the timely approval of drugs and biological products that treat rare diseases, including rare diseases in children.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Gene Therapy 64

XTalks

JANUARY 17, 2024

Changes in what clinical performance data is used to inform the trial design and site selection, new approaches to patient recruitment and the rise of advanced treatments such as cell and gene therapy are rewriting the script. Vidal shared their insights from the 2023 ESMO conference which occurred in Madrid.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research. So, when is the best time to incorporate the patient voice in clinical development?

Clinical Trials 87

Clinical Trials Clinical Trials Trials Clinical Development 87

Pharmaceutical Technology

DECEMBER 12, 2022

The successful implementation of these contracts is necessary to ensure that a newly approved drug or an investigational therapy that is ready to advance to the next pivotal stage of clinical evaluation is manufactured in a timely manner. Regulatory decisions and clinical trial news. Iomab-B met the durable complete remission endpoint.

Manufacturing 147

Manufacturing Drugs Packaging Packaging 147

Pharmaceutical Technology

JANUARY 8, 2023

There are at least six different biologics being studied in Phase III trials in COPD clinical programmes around the world. The trial did not achieve the primary endpoint of a statistically significant reduction of exacerbations in COPD patients. Biologic therapies for COPD are “ also showing great promise,” says Pettigrew.

Antibody 298

Antibody Trials Clinical Trials Clinical Trials 298

pharmaphorum

MARCH 15, 2022

A group of pharma companies and academic groups have joined forces with the Digital Medicine Society (DiMe) to develop standardised, digital clinical measures that can be used in the development of therapies for Alzheimer’s disease and related dementias.

Development 109

Development Pharma Companies Clinical Trials Clinical Trials 109

XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Contamination 98

Drug Discovery World

AUGUST 11, 2023

The US Food and Drug Administration (FDA) has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Slowing of disease progression was observed as early as six months with up to a 35% reduction in the first year of treatment.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Clinical Research 52

XTalks

JANUARY 8, 2024

Whether it’s for a treatment for a chronic ambulatory condition, precision medicine or cell and gene therapy, there is a massive uptick in clinical trial complexity. Most Phase II and Phase III studies have around 20 endpoints and 263 procedures per patient. Her advice revolves around two main strategies.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Gene Therapy 105

Crucial Data Soutions

APRIL 19, 2023

For clinical trial sponsors, the process of choosing which eClinical software vendors to engage with for their trials can take months. Clinical trials change constantly for many reasons, like adding patients, amending protocols, adopting new strategies, and others. and help researchers organize them into a useful format.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

pharmaphorum

SEPTEMBER 8, 2022

As Kerry Capozza, Founder and Executive Director of Global Parents for Eczema Research explains, “There’s no easy solution, unless the eczema can be treated and brought under control”. As yet, no new medical product has been approved on the basis of a digital endpoint.

Dermatology 52

Dermatology Production Radiology Development 52

pharmaphorum

JANUARY 17, 2022

The adoption of decentralised activities was a major factor in allowing clinical trials to continue during the early stages of the pandemic. Ben Hargreaves examines whether this adoption looks set to become a permanent feature of clinical trials moving into the future, rather than just supplying the tools to a temporary need.

Trials 105

Trials Clinical Trials Clinical Trials Clinical Research 105

XTalks

APRIL 5, 2024

Along with the discontinuation of Relyvrio, Amylyx also announced it will be laying off 70 percent of the company’s 384 employees as a part of “restructuring to focus on the company’s financial resources on upcoming clinical milestones.” It also failed to meet any of the trial’s secondary endpoints.

Trials 98

Trials Drugs Marketing FDA Approval 98

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Clinical Data Pipeline for Data Review and Analyses.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

WCG Clinical

JANUARY 4, 2024

Download report Intelligently Connecting Data and Insight to Navigate the Clinical Research Trends of Tomorrow Advancing health is all about connections. Connecting people, data, insights, and technology for a better, more efficient clinical trial experience. Despite this improvement, disconnects remain.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

Cloudbyz

SEPTEMBER 19, 2023

Introduction Clinical research is a complex and highly regulated field where meticulous attention to detail is paramount. Generative AI offers a groundbreaking solution to streamline this process, automating data extraction from protocol documents and ensuring faster, more accurate clinical study builds in Cloudbyz EDC.

Compliance 88

Compliance Clinical Trials Clinical Trials Clinical Research 88

pharmaphorum

NOVEMBER 2, 2022

Citeline provides intelligence, data and software for clinical trials, development and regulatory compliance and was formerly part of Informa was called Pharma Intelligence ahead of a rebranding earlier this year.

Clinical Trials 92

Clinical Trials Clinical Trials Marketing Life Science 92

Velocity Clinical Research

JUNE 12, 2023

If you snore loudly and feel tired, even after a full night's sleep, you might have sleep apnea, according to The Mayo Clinic and other healthcare experts. I treat a lot of people for sleep apnea, and I can see the ir difficulties in using continuous positive airway pressure (CPAP) therapy as a permanent solution ,” he explains. “As

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Research Trials 98

pharmaphorum

JANUARY 17, 2023

Unify, launched in December 2020, is AstraZeneca’s patient app and clinical trial support tool. Attrition in drug development for chronic disease is high, often because the wrong patients are selected for clinical trials,” Challis explained. Digital technology and ‘frictionless’ clinical trials. Dissecting heterogeneity.

Clinical Trials 98

Clinical Trials Clinical Trials Medicine Trials 98

Drug Discovery World

JULY 19, 2023

Donanemab met the primary endpoint of change from baseline until 18 months on the integrated Alzheimer’s Disease Rating Scale (iADRS). The primary endpoint of iADRS measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events.

Trials 52

Trials Clinical Trials Clinical Trials Research 52

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The goal of this two-part blog series is to give an overview of general clinical pharmacology considerations in biologics development. Expanded access to experimental biologics.

Development 161

Development Production Immune Response Licensing 161