Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

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Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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PPD

JUNE 7, 2023

By partnering with a contract research organization (CRO) that understands the challenges of liver disease clinical trials — and the complexities of working with pediatric populations — you can drive your treatment forward. Partnership with an experienced CRO is essential to your trial’s success.

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Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Specifically, U.S. Patients underlined the need for transparency by pharma and other related companies to build trust and partnership.

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PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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Conversations in Drug Development Trends

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.

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Drug Discovery World

OCTOBER 6, 2023

Total-body PET scans are quicker and more sensitive than the current technology, exposing patients to considerably lower doses of radiation, meaning more patients, including children, can participate in clinical trials. The post Total-body PET scanners will enhance UK drug discovery appeared first on Drug Discovery World (DDW).

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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thought leadership

JULY 20, 2023

Good clinical practice ( GCP ) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human subjects. This article has been updated since it's original publication date.

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Drug Discovery World

APRIL 25, 2023

University of California researchers have dosed the second participant in their clinical trial to identify a potential cure for HIV utilising CAR-T cell therapy. The trial is the first-in-human clinical study investigating the duo CAR-T cell therapy for the treatment of HIV. “We

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PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

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Drug Discovery World

SEPTEMBER 16, 2022

A biologic therapy for very young children with moderate to severe eczema (or atopic dermatitis) has been shown to be safe and effective in an international trial. These pivotal trial results strongly support the global approval of dupilumab in infants and children with eczema.

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Drug Discovery World

APRIL 11, 2023

The headlines this week have revealed a high level of clinical trial activity taking place internationally. You can listen below, or find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts.

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Advarra

JUNE 20, 2023

Typical clinical development timelines for anticancer drugs average an estimated 6.7 Oncology research is unique in many ways, including the challenges researchers face. Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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Drug Discovery World

FEBRUARY 9, 2023

1 This authorisation by the MHRA has been issued under Project Orbis, an international programme coordinated by the US Food and Drug Administration (FDA), which provides a framework for the concurrent submission and review of oncology medicines among international partners. 4 Updated median OS was 12.9 months compared to 11.3

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Advarra

OCTOBER 31, 2023

A common misconception in the manufacturing and research development landscape is quality systems can be bought off the shelf and there are no significant differences among the proliferation of quality systems. Clinical research is grounded in scientific integrity, participant safety, and data reliability.

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Advarra

JUNE 16, 2022

Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. Key Stakeholders .

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PPD

OCTOBER 31, 2023

Resourcing is one of the most critical services that a contract research organization (CRO) provides to its clients. For each trial, the partner team must rapidly recruit workers in sufficient numbers and with the correct skills to complete each segment of the project with agility and ease.

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Drug Discovery World

JANUARY 24, 2023

Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords. The overall virtual clinical trials market is currently valued at $7.8 However, it also made great strides in proving the success of these sorts of trials.

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Drug Discovery World

OCTOBER 20, 2022

DDW Multimedia Editor Megan Thomas takes a broad look at the drug discovery and development landscape in Japan and highlights how it is bolstered by government policies, investment, collaboration, start-up ecosystems and academic research. . Overview . Start-up ecosystem . Japan is evolving with such ecosystems.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. Vial’s track record includes over 750 completed trials and a network of more than 35 research sites.

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Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.

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Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

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Vial

MAY 8, 2024

The widespread adoption of EDC technology has revolutionized clinical operations , offering benefits such as improved data management, reduced trial timelines, remote monitoring capabilities, and enhanced data security. EDC is a system used in clinical trials to electronically record and manage subject data.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic.

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Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

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Conversations in Drug Development Trends

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. medical access, such as social determinants of health. altogether.”.

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Advarra

AUGUST 1, 2023

Efficient and compliant data capture can make or break the success of a clinical research trial. Typically used for investigator-initiated trials (IITs), EDC is used for transcribing paper source into an application, with a team providing downstream analysis for endpoint adjudication and data submission.

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PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

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The Pharma Data

JUNE 26, 2021

Together with our research partners, BIG conducts landmark, practice-changing trials that can have a significant impact on the lives of women with breast cancer,” sa id David Cameron , Chair of the BIG Executive Board. Adjuvant therapy helps prevent and delay the progression of disease into the later setting.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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