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

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

Cloudbyz

APRIL 8, 2024

Understanding Risk-Based Monitoring (RBM) Risk-Based Monitoring is an innovative approach to clinical trial monitoring that emphasizes the importance of identifying, assessing, and mitigating risks associated with a trial. Risk Assessment Not necessarily based on a comprehensive risk assessment plan.

Clinical Trials 84

Clinical Trials Clinical Trials Trials Development 84

WCG Clinical

MAY 15, 2023

Additionally, participants with cognitive limitations may not be able to navigate the eDiary platform, and even people without cognitive issues may struggle with complex assessments. Ideally, sponsors would solicit patient insight early in endpoint development. Do the questions get to the core of what is meaningful to patients?

Clinical Research 52

Clinical Research Development Trials Research 52

VirTrial

JANUARY 2, 2024

They also often rely on CROs to recommend eClinical solutions that can help meet critical milestones on time. Signant supported the trials that led to the approval of lecanemab with many of our endpoint quality solutions leveraged throughout the course of the years-long program.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical 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.

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Clinical Trials Clinical Trials Trials Life Science 98

pharmaphorum

NOVEMBER 20, 2022

In addition, it offered the opportunity for new solutions and approaches to many of today’s healthcare challenges. For example, experts can advise on how best to manage logistics or how to ensure that assay endpoints selected will determine preclinical efficacy, but also align with the clinical endpoints during phase I and beyond.

Vaccination 98

Vaccination Vaccine Development Clinical Development 98

XTalks

JANUARY 19, 2022

“This focus has shifted to the concept of patient centric trials in which patient safety and convenience are prioritized without compromising data integrity and clinical trial endpoints,” says Dr. Richard Lee, MD, Senior Medical Director of the Medical Department at the global contract research organization (CRO) Medpace. Trial access.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

JULY 8, 2022

They can solve some immediate challenges with participation in research by conducting eCOA (electronic clinical outcome assessment) remotely or doing virtual visits. However, few of the current digital solutions are medical-grade devices and more work is needed to develop tools that are fit for purpose. Novel digital endpoints.

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Clinical Trials Clinical Trials Trials Regulation 99

WCG Clinical

APRIL 28, 2023

Click here to learn more.

Research 52

Research Clinical Trials Clinical Trials Clinical Research 52

pharmaphorum

JUNE 8, 2022

The number of technological solutions aiming to improve sleep has boomed in recent years, some of which do not require the user to do anything more than download specific software. Novel digital endpoints. The post Sleep tracking and the potential for digital endpoints appeared first on.

Research 98

Research Hormones Pharma Companies Development 98

WCG Clinical

MAY 1, 2023

A: Most, if not all, of our outcome assessments in multiple sclerosis are incomplete, or they only capture certain elements. Whenever we can cause the scoring to be done exactly the same way each visit by each evaluator, we can reduce variability in outcome assessments. to share his experiences. International Journal of MS Care.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Dermatology 52

XTalks

MAY 15, 2023

Chiesi Global Rare Diseases is a specialized division of the Chiesi Group committed to developing therapies and solutions for individuals affected by rare diseases. “We established Chiesi Global Rare Diseases to deliver innovative therapies and solutions for people affected by rare diseases.

FDA Approval 98

FDA Approval Gene Genetics Clinical Trials 98

The Pharma Data

JUNE 1, 2022

Zuranolone 50 mg demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints. Key Secondary Endpoint. 0.82) compared with -11.6 0.82) for women who received placebo (LS mean difference -4.0 p= 0.0052).

Development 52

Development Drugs Medicine Clinical Development 52

The Pharma Data

SEPTEMBER 29, 2020

The therapy was approved in two formulations: a tablet and oral solution to treat those over two years old. The study assessed patients taking either a 5mg tablet or 1mg oral solution versus a placebo. The study assessed patients taking either a 5mg tablet or 1mg oral solution versus a placebo.

FDA Approval 52

FDA Approval Drugs Trials Development 52

Crucial Data Soutions

APRIL 3, 2023

Both technology and process innovations are giving researchers the flexibility to expand the kinds of data they collect, leading to the addition of new endpoints to prove the efficacy and safety of therapies and data that helps to differentiate medical products post-release. Getting started doesn’t need to be overly complicated, either.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

pharmaphorum

JANUARY 17, 2022

The opportunity to implement such solutions has evolved rapidly over time, as the public, in general, are much more comfortable using and living with technology that can assist in DCTs, such as smartphones or smart devices. The post Decentralised trials: beyond the pandemic appeared first on.

Trials 105

Trials Clinical Trials Clinical Trials Clinical Research 105

XTalks

NOVEMBER 1, 2023

It has been confirmed by independent studies that integrating patient perspectives at the initial stages of clinical development can produce trials with endpoints that are more meaningful. Type 1 Diabetes Treatment Understanding the patient’s perspective can lead to innovative solutions.

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Clinical Trials Clinical Trials Trials Clinical Development 87

pharmaphorum

AUGUST 4, 2020

Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. The authors also note that orphan drug trials with higher p values and surrogate endpoints are often accepted for assessment in the country.

Drugs 121

Drugs Manufacturing Marketing Regulation 121

Camargo

NOVEMBER 20, 2020

Toxicologic endpoints and biomarkers – Sponsors need to assess what in-life or post-mortem parameters to evaluate in relation to the human-to-animal comparisons of developmental periods. Post-treatment periods – Delayed or non-reversible toxicities will need to be assessed.

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Clinical Trials Clinical Trials Drugs Production 140

Drug Discovery World

OCTOBER 12, 2022

DDW sits down with Mark Matson, Senior Solution Specialist for Sensor Cloud at Medidata, a Dassault Systèmes company, about the use of digital biomarkers in life sciences and how they can help advance our understanding of disease. . How do we define digital biomarkers? . What expertise does Medidata have in the digital biomarker space?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Sales 52

Crucial Data Soutions

APRIL 21, 2023

Further, many facets of clinical trials call for highly specialized help, whether that be process expertise or the ability to provide technology solutions. Whatever potential rewards a technology promises, like the ability to look for new endpoints, or the ability to analyze data in real-time, etc., Clinical trials are not simple.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

pharmaphorum

DECEMBER 11, 2020

The transaction will integrate Bioclinica’s expertise in imaging with ERT’s expertise in electronic clinical outcome assessment, cardiac safety, respiratory and wearables. The combined company will deliver data analytics, insights, business intelligence, virtual patient visits and hybrid technological solutions.

Trials 63

Trials Development Vaccination Vaccine 63

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. Katrina Rice is an accomplished Chief Delivery Officer at eClinical Solutions.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

WCG Clinical

JANUARY 4, 2024

But while digital devices, mobile applications, and online communication methods are useful tools, they are not complete solutions. Because of this, active clinical research sites have become saturated and are facing unrelenting pressure to meet protocol endpoints within the timelines dictated.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Pharmaceutical Technology

JANUARY 8, 2023

“However, despite around 20% of severe asthma patients having uncontrolled disease, only a relatively small fraction of these eligible patients are currently on biologics ,” says David Pettigrew, CEO of digital therapeutics developer my mhealth, which has created asthma and COPD biologic solutions.

Antibody 298

Antibody Trials Clinical Trials Clinical Trials 298

pharmaphorum

SEPTEMBER 24, 2020

The app uses data input by carers or doctors, including short video footage, and deploys machine learning to assess whether a child is developing at a healthy pace and look for signs of ASD. It’s reported that parents can often spot the early signs of developmental problems within 18 months. “We

Behavioural Health 133

Behavioural Health Doctors Doctor Development 133

Drug Discovery World

OCTOBER 10, 2022

As a result, many apparently attractive new drug candidates in neuroscience subsequently fail to meet their primary endpoints in clinical trials. This article reviews the challenges and solutions required to expand the use of digital biomarkers to meet the growing demand for more effective drugs that act on the central nervous system. .

Development 52

Development Drugs Clinical Trials Clinical Trials 52

XTalks

MAY 26, 2023

Following subcutaneous injection, Brixadi undergoes a spontaneous transformation from a low viscous solution to a nanostructured liquid-crystalline gel. Weekly and monthly Brixadi met the primary endpoint of non-inferiority for responder rate versus daily SL BPN/NX (16.9 percent versus 14.0 percent, respectively; p<0.001).

FDA Approval 97

FDA Approval Containment Clinical Trials Clinical Trials 97

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. Searching for the right solution. I was left frustrated that there wasn’t the type of solutions that I was looking for. This brings us to VivoSense.

Clinical Trials 110

Clinical Trials Clinical Trials Trials Development 110

XTalks

APRIL 25, 2024

Physical Reverse Remodeling Devices Physical reverse remodeling devices are innovative solutions designed to modify the structure of the heart’s ventricles in patients with heart failure. This randomized, open-label trial aims to enroll 400 patients across 80 sites, with a focus on assessing the device’s safety and efficacy.

Development 111

Development Trials Clinical Trials Clinical Trials 111

XTalks

OCTOBER 4, 2023

HEOR involves the assessment of the economic implications and real-world outcomes of cutting-edge therapies, providing essential insights into their cost-effectiveness, patient outcomes and overall societal impact. Here are the endpoints that payers care about. Here’s how we can best demonstrate the value of the product.”

Marketing 105

Marketing Development Drugs Gene Therapy 105

The Pharma Data

JUNE 18, 2023

Emgality did not meet the study’s primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days. And, Emgality performed numerically better on key secondary endpoints of the 3-month trial. Response rates were similar.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Medicine 40

The Pharma Data

NOVEMBER 8, 2021

About HER-MES HER-MES (NCT03828539) is the first randomized, double-blind, double-dummy, active-controlled, parallel-group Phase IV study to assess tolerability (as assessed by the discontinuation rates due to adverse events) and efficacy of Aimovig versus topiramate in a patient-centered setting.3

FDA Approval 52

FDA Approval Gene Trials Development 52

Roots Analysis

OCTOBER 29, 2023

Over time, the healthcare industry needs an advanced technological solution to overcome such delays. Decentralized clinical trials (DCTs) can be a solution to all the aforementioned challenges. While some appointments in a clinical trial are essential, others are simply standard follow-ups to oversee clinical outcome assessments.

Clinical Trials 40

Clinical Trials Clinical Trials Clinical Research Trials 40

XTalks

JULY 27, 2022

The featured speakers will discuss why the industry has moved towards patient-centric data collection and the benefits of a clinical platform approach over siloed solutions. The PERMP total score across all the post-dose timepoints was the primacy efficacy endpoint. Additionally, patient safety was monitored and assessed at each visit.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

JUNE 10, 2022

In draft guidance, the health technology assessment (HTA) organisation has recommended Vazkepa (icosapent ethyl) as a treatment option for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides in their blood who are already taking statins.

Drugs 52

Drugs Marketing Medicine Production 52