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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ProRelix Research

MAY 15, 2023

Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drug development process and conducting clinical trials. In this […] The post Clinical Research Organizations: Importance, Services, Selection Process and Future.

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thought leadership

JULY 17, 2023

Decentralized clinical trials (DCTs) have emerged as a transformative approach in clinical research, offering unique benefits that challenge the traditional models. In this blog post, we will delve into the decision-making process of whether to embrace DCTs or stick with conventional trials.

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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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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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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.

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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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Antidote

MAY 31, 2023

IWRS, IVRS, and IRT systems are an important part of the clinical research process, as they are used to manage patient enrollment, randomization, drug supply, reporting, and more during clinical trials.

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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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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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Antidote

JULY 27, 2023

Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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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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Olympian Clinical Research

MARCH 19, 2024

Clinical trials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. Participating in a clinical trial is a significant decision that can have profound benefits, not only for the individual participant but also for future patients and the broader medical community.

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Antidote

MARCH 12, 2024

For many people, participating in a research study presents an interesting opportunity with many benefits to volunteering. While there are many types of clinical research, all with distinct goals and timelines, trial volunteers will follow a similar path when taking part. Read on to learn more about the process.

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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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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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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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Antidote

SEPTEMBER 19, 2024

Facebook has over 2 billion daily users, making it one of the most effective ways clinical research recruitment agencies share clinical trial opportunities with patients. But the platform isn't always intuitive, and small mistakes can lead your ads to be rejected, or reach the wrong audience.

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Clinical Trials Trials Clinical Research Research 52

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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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

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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Quanticate

SEPTEMBER 11, 2024

The Importance of SAS Quality Control in Clinical Trials Quality control (QC) in clinical trials is essential for ensuring the integrity and reliability of data. Leveraging SAS (Statistical Analysis System) for QC processes offers a powerful solution for clinical researchers.

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Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

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Conversations in Drug Development Trends

JULY 9, 2024

This shortage is most prevalent in the starting doses and is leading to extensive issues with patient access and delays in clinical trial start-up times as most of the obesity trials incorporate initiating GLP-1 agonist as part of the protocols.

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Antidote

NOVEMBER 21, 2022

There are many clinical trial blogs out there, but what sets the best ones apart? Our favorites are the ones that don’t simply cover news — instead, they aim to be go-to sources for informed positions on how to improve the medical research process.

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PPD

MAY 18, 2023

Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. There’s little time to lose.

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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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Quanticate

APRIL 12, 2024

The landscape of clinical research is undergoing major changes with virtual clinical trials driving these transformations. These innovative trials promise to revolutionise the way medical research is conducted, making it more accessible, efficient, and patient-centric than ever before.

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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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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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Crucial Data Solutions

MAY 2, 2024

In clinical research, innovations in technology are moving us down an exciting path, transforming traditional methodologies and paving the way. The post Wearables in Clinical Trials: Real Benefits Beyond the Hype appeared first on Crucial Data Solutions.

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LifeSciVC

JULY 17, 2024

Identifying the right targets, de-risking those targets, and then executing trials requires significant capital, strategic focus, and time. The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.

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Perficient: Drug Development

SEPTEMBER 25, 2024

Clinical trial data management is critical to pharmaceutical research, yet it remains a significant challenge for many organizations. The industry faces several persistent hurdles: Data fragmentation: Research teams often struggle with siloed information across departments, hindering collaboration and comprehensive analysis.

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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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PPD

DECEMBER 7, 2023

The Sustainable Healthcare Coalition , a not-for-profit, health care sector-led group based in the United Kingdom, concluded that globally, clinical research could generate the equivalent of 100 million tons of carbon dioxide (CO2) emissions each year. These results can then be used to enhance the accuracy of the predictive model.

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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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