XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research. Integrating DHTs Across Drug Development Phases Dr.

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 16, 2024

Under […]

Clinical Trials 156

Clinical Trials Clinical Trials Trials Clinical Research 156

XTalks

NOVEMBER 19, 2024

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinical trial designs.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Production 59

Pharma Mirror

JUNE 8, 2022

The post Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China appeared first on Pharma Mirror Magazine. According to the Endpoints ASCO session: “China and the US are the world’s largest oncology research destinations, and the.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Clinical Development 130

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Production 67

Production Clinical Development Development Regulation 67

ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. MGI puts the value of this contribution to clinical development at $15 billion to $25 b illion.

Clinical Trials 69

Clinical Trials Clinical Trials Trials Life Science 69

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

Clinical Development 91

Clinical Development Development Clinical Trials Clinical Trials 91

XTalks

SEPTEMBER 25, 2024

Patient-centricity isn’t a catchphrase in clinical trials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, Clinical Trial Financial Management Medidata Alicia C.

Clinical Trials 75

Clinical Trials Clinical Trials Trials Clinical Research 75

Outsourcing Pharma

OCTOBER 10, 2024

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

Clinical Trials 90

Clinical Trials Clinical Trials Clinical Development Drugs 90

Outsourcing Pharma

JANUARY 9, 2024

Equally, OSP was delighted to speak to him to discuss the evolution of data management in clinical development and how intelligent data use can reduce clinical trial cancellations, minimise protocol amendments, and accelerate patient recruitment. Gen Li is president and founder of Phesi.

Clinical Development 59

Clinical Development Development Clinical Trials Clinical Trials 59

Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

Clinical Trials 95

Clinical Trials Clinical Trials Trials Clinical Development 95

Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

Clinical Development 341

Clinical Development Clinical Trials Clinical Trials Trials 341

XTalks

SEPTEMBER 12, 2024

Ryan Brown Regional Vice President Sales-Trial Landscape H1 Diversity in clinical trials is not just a regulatory box to check — it’s an ethical imperative and a scientific necessity. For instance, one common barrier is language.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Outsourcing Pharma

MARCH 13, 2024

In the fast-evolving landscape of clinical trials, technological advancements play a vital role in streamlining processes, enhancing efficiency, and ultimately improving patient outcomes.

Clinical Trials 99

Clinical Trials Clinical Trials Trials Clinical Development 99

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

Clinical Trials 96

Clinical Trials Clinical Trials Regulation Trials 96

STAT News

OCTOBER 13, 2022

Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinical trial, a significant setback for the company’s only medicine in clinical development.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Drugs 105

Outsourcing Pharma

JULY 2, 2024

Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.

Clinical Trials 82

Clinical Trials Clinical Trials Trials Clinical Development 82

XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. Evolution in Oncology Clinical Trial Design Recent discussions at ESMO highlight a shift in how clinical trials are designed and conducted.

Clinical Trials 110

Clinical Trials Clinical Trials Trials Gene Therapy 110

XTalks

AUGUST 19, 2024

The synergy between clinical trial quality and operations teams is vital for delivering value to sponsors. Clinical trial sponsors often face the challenge of managing complex projects with multiple stakeholders, each with their own priorities and workflows.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Life Science 64

XTalks

JULY 29, 2024

Orphan drug development poses many challenges that are unique to rare diseases, including recruitment in small patient populations, variable progression with heterogenous clinical manifestations and limited understanding of disease progression and natural history.

Clinical Trials 91

Clinical Trials Clinical Trials Trials Research 91

Clinical Trial Podcast

SEPTEMBER 26, 2022

To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. Cohen to the Clinical Trial Podcast.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

XTalks

AUGUST 16, 2024

The effectiveness of clinical trials often depends on the quality and depth of the data utilized. This rich data resource has significant potential to innovate clinical trials, providing real-world, timely insights that can enhance success and streamline trial processes.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

Pharmaceutical Technology

JUNE 9, 2023

The therapy showed that it can inhibit the production of cytokine from both CD4+ T cells and ILC2, and completely suppressed skin allergic reactions in a monkey model in pre-clinical trials. Upstream Bio CEO Samantha Truex stated: “Our IND has been cleared by the FDA to pursue Phase II programmes in both asthma and CRSwNP.

Clinical Development 147

Clinical Development Development Life Science Clinical Trials 147

XTalks

AUGUST 22, 2023

Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is Clinical Trials For All?

Clinical Trials 76

Clinical Trials Clinical Trials Trials Clinical Research 76

Outsourcing Pharma

JANUARY 9, 2024

has announced a new intelligent automation technology applied across its clinical trials platform it hopes will cut standard trial build timelines by at least half. Medable Inc.

Clinical Trials 107

Clinical Trials Clinical Trials Trials Clinical Development 107

Outsourcing Pharma

MAY 22, 2024

With Clinical Trials Day earlier in the week (May 20) OSP spoke to patient-focused companies to see what was happening in the clinical trials arena.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

pharmaphorum

AUGUST 24, 2022

Diversity in clinical trials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinical trial participation for underserved groups is an essential part of addressing health inequalities. Clinical trial participation, she went on, was vital.

Clinical Trials 109

Clinical Trials Clinical Trials Trials Development 109

XTalks

JULY 9, 2024

In the dynamic landscape of clinical trials, ensuring compliance and maintaining high-quality standards are paramount. The field of quality and compliance in clinical trials is undergoing significant transformations driven by technological advancements, regulatory changes and evolving industry practices.

Compliance 59

Compliance Clinical Trials Clinical Trials Trials 59

XTalks

SEPTEMBER 16, 2024

Lung-MAP is a pioneering clinical trial designed to simultaneously test multiple treatments for non-small cell lung cancer (NSCLC) under a single, comprehensive “umbrella” protocol. Could you give us an overview of the Lung-MAP trial and its significance in the treatment of NSCLC?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Outsourcing Pharma

JULY 27, 2023

The EMA organized a task force made up of various stakeholders to gather insights on potential EU-level actions to improve the set up of clinical trials during public health emergencies.

Clinical Trials 92

Clinical Trials Clinical Trials Trials Clinical Development 92

CTTI (Clinical Trials Transformation Initiative)

OCTOBER 15, 2024

The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making The post The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making appeared first on CTTI.

Clinical Development 40

Clinical Development Development Trials 40

Outsourcing Pharma

MARCH 1, 2024

In the dynamic realm of clinical trials, where innovation and patient care intersect, Advarra believes it stands as a beacon of progress, continually revolutionizing how medical research is conducted.

Clinical Trials 76

Clinical Trials Clinical Trials Trials Research 76

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

Outsourcing Pharma

OCTOBER 20, 2023

Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.

Clinical Trials 102

Clinical Trials Clinical Trials Trials Drugs 102

pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. How the NIHR’s Patient Engagement in Clinical Development service can help.

Clinical Trials 116

Clinical Trials Clinical Trials Trials Life Science 116