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March 7, 2024: New Report Sets Out Posttrial Responsibilities in Pragmatic Clinical Trials

Rethinking Clinical Trials

MARCH 7, 2024

Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. Read the full article.

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New HIV Prevention Drug Shows 100% Efficacy in Clinical Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 14, 2024

A large clinical trial in South Africa and Uganda has shown that a twice-yearly injection of a new pre-exposure prophylaxis drug gives young women total protection from HIV infection. All three medications […]

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How clinical trials can use AI responsibly and effectively

Pharmaceutical Technology

AUGUST 15, 2024

Strong measures must be in place to safeguard confidential patient data when deploying AI to optimise clinical trial translations.

Clinical Trials

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

AAIC 2024: the evolution of Alzheimer’s clinical trials

Pharmaceutical Technology

JULY 29, 2024

Clinical trial trends point to studying combination therapies and lifestyle changes using alternate designs in Alzheimer’s research.

Clinical Trials

Including Patients with Borderline Personality Disorder in Clinical Trials

Worldwide Clinical Trials

MAY 10, 2024

Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.

Clinical Trials

Advent of decentralised clinical trials spurs need for robust rules like USFDA’s Cancer Clinical Trial Eligibility Criteria

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 19, 2024

As India sees the emergence of decentralised clinical trials driven by digital health technologies remote patient monitoring, Electronic Health Records andpatient data capture, it also sees robust rules like the US FDA’s Cancer Clinical Trial Eligibility Criteria as an advantage.

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Navigating clinical trial disruption: growing trends and new technologies

Pharmaceutical Technology

OCTOBER 22, 2024

Disruption is a pressing problem in the pharmaceutical world; patient health depends on clinical trial organisers avoiding it

Clinical Trials

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.

September 30, 2024: New Guide From NIH Collaboratory Promotes Health Equity in Pragmatic Clinical Trials

Rethinking Clinical Trials

SEPTEMBER 30, 2024

The NIH Pragmatic Trials Collaboratory’s Health Equity Core released a new Health Equity in Pragmatic Clinical Trials guide designed to help research teams define health equity and provide examples of how to promote it in clinical research. ” View the complete guide. . ” View the complete guide.

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Don’t let your samples slip: Why every clinical trial needs biospecimen management

Bio Pharma Dive

OCTOBER 28, 2024

Assure the integrity and efficiency of your clinical trials with support from a Biospecimen Manager.

Clinical Trials

September 11, 2024: HARMONIE and a New Approach to Commercial Clinical Trials, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

SEPTEMBER 11, 2024

Professor Saul Faust In this Friday’s PCT Grand Rounds, Saul Faust of the University of Southampton will present “The HARMONIE Trial: Reimagining How to Design and Deliver Contract Commercial Clinical Trials.” ” The Grand Rounds session will be held on Friday, September 13, 2024, at 1:00 pm eastern.

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Optimizing Patient-Driven Site Engagement in Rare Disease Clinical Trials

Worldwide Clinical Trials

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

Clinical Trials

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays.

Women want to participate in clinical trials. Lack of flexibility is still a problem.

Bio Pharma Dive

APRIL 8, 2024

Underrepresentation of women in clinical trials affects the resulting drugs that become available later. Even small changes could boost participation.

Clinical Trials

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How Pharmacogenomics Can Benefit Your Clinical Trial

Worldwide Clinical Trials

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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ICMR and Panacea Biotec initiate phase 3 clinical trial for the first indigenous dengue vaccine, DengiAll

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 19, 2024

The Indian Council of Medical Research (ICMR) and Panacea Biotec have announced the initiation of the first-ever phase 3 clinical trial for a dengue vaccine in India. The trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec.

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Biotechs investigate ways to adapt to new clinical trial regulation and economic flux

Pharmaceutical Technology

SEPTEMBER 20, 2024

The Outsourcing in Clinical Trials New England conference will gather pharma experts to discuss the current clinical trial landscape.

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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Most trials won’t be fully virtual, but all trials will be more virtual.

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Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 29, 2024

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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Comprehensive clinical trial services

Pharmaceutical Technology

APRIL 18, 2024

Discover the key factors and latest advancements in clinical trial services to ensure the success of your clinical research. Find your comprehensive guide here.

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Pioneering ePRO and eCOA innovations for next-generation clinical trials

Pharmaceutical Technology

SEPTEMBER 16, 2024

As clinical trials become more complex, the need for innovative solutions to capture patient data accurately and efficiently is more critical than ever.

Clinical Trials

How to optimize efficiencies at site-centric clinical trials

Pharmaceutical Technology

SEPTEMBER 4, 2024

By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.

Clinical Trials

Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies.

Understanding the Patient Journey: Overcoming Barriers to Enrolling Depression Clinical Trials

Worldwide Clinical Trials

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. Treatment Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial.

Clinical Trials

Revolutionizing clinical trials: Unlocking peak efficiency with total laboratory automation in bioanalysis

Bio Pharma Dive

DECEMBER 4, 2023

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.

Clinical Trials

Clinical trials and development services

Pharmaceutical Technology

APRIL 4, 2024

Download our comprehensive list of leading specialist companies offering clinical trials and development services for free today.

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Europe's share of clinical trials falling, with China rising

pharmaphorum

OCTOBER 22, 2024

The proportion of commercially sponsored clinical trials run in Europe almost halved over the last 10 years and is now trailing China

Clinical Trials

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. How can you reliably supply these studies?

Clinical Research

Embracing diversity in psychiatry and neurology clinical trials

pharmaphorum

SEPTEMBER 6, 2024

Embracing diversity in psychiatry and neurology clinical trials is crucial for ensuring that treatments are effective for all populations. Learn about the importance of diversity in clinical trials and how to promote inclusivity in research.

Clinical Trials

Evaxion’s AI-immunology platform shines in multiple clinical trials

BioPharma Reporter

OCTOBER 10, 2024

Evaxionâs proprietary AI-Immunology platform has shown in clinical trials that it can select clinically relevant cancer vaccine targets.

Clinical Trials

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Obesity Clinical Trials: Combining Patient-Centric Care with Scientific Rigor

XTalks

OCTOBER 22, 2024

Given these dire statistics, the need for innovative approaches in obesity clinical trials has never been more urgent. These trials are crucial for understanding and managing obesity while improving strategies to combat this complex health issue.

Clinical Trials

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Decentralized Clinical Trials Back in the Spotlight Thanks to New FDA Guidance

ACRP blog

OCTOBER 16, 2024

Just when it seemed as if decentralized clinical trials (DCTs) were in danger of becoming “yesterday’s news” in light of all the attention being paid lately to applications of artificial intelligence in the clinical research enterprise, the tables have turned, if perhaps only briefly, thanks to the release of finalized new U.S.

Clinical Trials

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials.

Clinical Supply

How to advance diversity, equity and inclusion in clinical trial recruitment

pharmaphorum

SEPTEMBER 25, 2024

Discover strategies and best practices for advancing diversity, equity, and inclusion (DEI) in clinical trial recruitment. Learn how to improve representation and access for underrepresented populations.

Clinical Trials

How long do clinical trials take?

Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

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Why informed patient consent is vital for successful clinical trials

pharmaphorum

JULY 1, 2024

Informed patient consent is crucial for the success of clinical trials. Learn about the importance of consent in clinical trials and how it impacts the outcomes.

Clinical Trials

How CTMS Enhances Clinical Trial Efficiency and Compliance

Cloudbyz

AUGUST 30, 2024

Clinical trials are the backbone of medical advancements, but their complexity and the regulatory environment pose significant challenges to researchers, sponsors, and clinical trial managers. Managing these trials efficiently while ensuring compliance with stringent regulatory standards is paramount to their success.

Compliance

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Who decides whether you get into a clinical trial?

Antidote

MAY 30, 2024

One may choose to participate in a clinical trial for many reasons. However, deciding to enroll in a clinical trial is only one part of the process. Volunteering often has multiple benefits, from advancing medical research to gaining access to cutting-edge medical care.

Clinical Trials

The Challenges of Adopting Decentralized Clinical Trial Platforms

Cloudbyz

APRIL 17, 2024

Decentralized clinical trial (DCT) platforms represent a paradigm shift in the way clinical research is conducted. By leveraging technology, DCTs aim to make clinical trials more accessible and convenient for patients, reduce costs and increase efficiency.

Clinical Trials

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Mastering Clinical Trial Timelines

Imperical Blog

AUGUST 20, 2024

Realistic, well-managed clinical trial timelines are essential to the success and timeliness of clinical studies. We often say every clinical trial is made up of a million moving parts. Read on for more information about keeping your projects on track.

Clinical Trials

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

MARCH 4, 2024

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

Clinical Trials

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management.