Antidote

SEPTEMBER 22, 2023

Connecting patients with clinical research opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinical trial but to do this effectively, it’s critical to have accurate information.

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Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

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Antidote

AUGUST 17, 2022

Clinical research studies around the United States are in need of participants to learn more about various conditions.

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BioPharma Drive: Drug Pricing

JUNE 12, 2023

Decentralized clinical trials (DCTs) bring many benefits to the clinical research process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.

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Clinical Trials Trials Clinical Research Research 111

PPD

JUNE 20, 2024

Acceleration in every step of clinical research is critical to pharmaceutical developers. Yet, today’s clinical research sponsors face significant challenges. Rather than accepting the persistent delays in clinical research as disruptive, yet unavoidable, we believe they underscore the need for greater efficiency.

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Advarra

SEPTEMBER 19, 2024

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

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Clinical Research Research Clinical Trials Trials 52

Vial

MARCH 6, 2024

The field of clinical research is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinical research conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.

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Clinical Research Research Clinical Trials Trials 52

thought leadership

JULY 15, 2024

The term Functional Service Provider (FSP) concept is highly regarded in the field of clinical research. With drug discovery and clinical trials becoming more complex, pharmaceutical firms and research organizations are searching for flexible and customized solutions.

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Clinical Research Research Clinical Trials Pharmaceuticals 52

Antidote

JUNE 7, 2023

Before any new medical treatment, therapy, or device is approved, it must first be tested through clinical research studies. While some research studies seek participants with illnesses or conditions to be studied in the clinical trial, it is not always necessary to have a specific illness or condition to participate.

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ProRelix Research

SEPTEMBER 1, 2024

Clinical trials are undergoing a paradigm shift from a site-centric or traditional approach wherein the patients are required to go to central sites for consent processes, assessments, and safety monitoring […] The post Telemedicine: How Remote Monitoring is Changing Clinical Research appeared first on ProRelix Research.

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Clinical Research Research Clinical Trials Trials 52

Crown Bioscience

OCTOBER 18, 2024

In recent years, the landscape of clinical trials has evolved significantly, particularly in oncology research. Two innovative trial designs that have gained prominence in Phase II are the basket and umbrella designs.

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Clinical Trials Trials Clinical Research Research 98

PPD

AUGUST 5, 2024

Where the historical goal was to delay progression of the disease, more recent research focuses on new medications and disease-modifying therapies with potential for generating clinical improvements and, ultimately, reversal of the disease. None offers a cure for PAH.

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Clinical Trials Trials Clinical Research Disease 98

Antidote

APRIL 8, 2024

Increasing racial diversity in clinical research is a common topic in the industry, and for good reason.

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PPD

JUNE 24, 2024

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.

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PPD

AUGUST 16, 2023

The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinical trial (DCT) models. At the end of 2022, the PPD clinical research business of Thermo Fisher Scientific surveyed key leadership and staff on the frontline of clinical trial execution across the industry.

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Clinical Trials Trials Clinical Research FDA 98

PPD

MAY 18, 2023

For neurodegenerative disease research, the care partner, or caregiver, is equally important as the person with dementia. Even with stronger awareness of studies, drug developers must contend with the inherent lack of trust between the dementia community and clinical trials. There’s little time to lose.

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Clinical Trials Trials Clinical Research Doctors 86

Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. A clinical trial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV.

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Clinical Research Research Clinical Trials Trials 52

Conversations in Drug Development Trends

JULY 29, 2024

Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research. These data emphasize the need for precise and meaningful body composition endpoints in T2D and obesity clinical trials.

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Clinical Research Research Clinical Trials Treatment 52

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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Trials Clinical Trials Clinical Research Disease 98

Quanticate

SEPTEMBER 27, 2024

Advancements in preclinical and clinical research are driving major changes across various therapeutic areas, steering the industry into a new phase of medical innovation. Our aim is to provide valuable insights for industry professionals, stakeholders, and all those invested in the future of medical science.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? billion in 2022 and is projected to reach US$10.2

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Clinical Research Clinical Trials Research Trials 52

Antidote

DECEMBER 9, 2022

Participating in a clinical research study can have many benefits. From offering specialized care to providing participants with potential new treatment options, finding the right clinical trial can lead to positive outcomes for today’s patients and unlock breakthroughs for those diagnosed in the future.

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FDA Law Blog: Biosimilars

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. In other words, the inspectional output was inversely proportional to the importance of clinical research.

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Clinical Research FDA Research Clinical Trials 59

PPD

FEBRUARY 19, 2024

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

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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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Trials Disease Clinical Trials Clinical Research 75

PPD

NOVEMBER 16, 2023

In clinical research, access to timely, curated data is critical to mitigate risk and drive operational effectiveness. One common challenge for clinical trial sponsors is coordination of data across an array of vendors and systems. Expertise to easily assimilate diverse data systems and anticipate gaps.

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Clinical Research Research Clinical Trials Trials 58

Advarra

AUGUST 8, 2024

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Here are some key requirements for “high risk” AI systems as they relate to clinical trials.

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PPD

SEPTEMBER 4, 2024

Over the last decade, the clinical research industry has seen investigator site models evolve, pushing contract research organizations (CROs) to think and collaborate more creatively. It is also important to ensure that the needs of investigators are met to provide a seamless clinical trial experience.

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Clinical Trials Clinical Research Trials Research 97

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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Clinical Research Research Clinical Trials Regulations 52

PPD

JULY 6, 2023

It’s estimated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs), highlighting just how much sponsors value — and rely on — the work that CROs perform. Surveys show that CROs improve trial efficiency and increase productivity.

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Clinical Trials Trials Drug Development Testimonials 98

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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PPD

OCTOBER 8, 2024

With FSO, all clinical trial tasks (e.g., study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.) are outsourced to a contract research organization (CRO) partner. clinical operations, pharmacovigilance, etc.) clinical operations, pharmacovigilance, etc.)

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Trials Clinical Trials Clinical Development Clinical Research 98

Advarra

OCTOBER 17, 2023

Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. Oftentimes, sites hold off billing for specific visits or procedures related to a trial if they are not 100% sure the item is billable.

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Clinical Research Research Clinical Trials Compliance 52

Broad Institute

OCTOBER 3, 2023

Broad Clinical Labs established to expand clinical services By Leah Eisenstadt October 3, 2023 Breadcrumb Home Broad Clinical Labs established to expand clinical services Formerly the Clinical Research Sequencing Platform, the cutting-edge laboratory at the Broad Institute is poised to further accelerate clinical genomics.

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On Medicine

FEBRUARY 8, 2024

Why is the CHARMER trial important? In previous research by members of the CHARMER team, older people and their carers told us that they would like their medicines reviewed by doctors during their hospital stay. The CHARMER trial aims to i ncorporate proactive deprescribing as a routine aspect of care in Older People’s Medicine wards.

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Quanticate

AUGUST 19, 2024

An audit trail is a comprehensive log that records all activities, including modifications, additions, and deletions of data, within a clinical trial. In recent years the requirement for maintaining a robust audit trail has become crucial for ensuring data integrity, transparency, and compliance with regulatory requirements.

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Regulations Clinical Research Clinical Trials Compliance 52

Olympian Clinical Research

OCTOBER 30, 2020

At Olympian Clinical Research we’ve gotten a chance to work with countless Schizophrenia patients over the years through our clinical trials, and we know just how untrue many of the common assumptions about Schizophrenia really are. . Myth #2: People with Schizophrenia are violent. Learn More.

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