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

JULY 29, 2024

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

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PPD

NOVEMBER 11, 2024

Accelerate your drug development and clinical trial goals and benefit from our 360° CDMO and CRO solutions and expertise. Partner with us The post Redefining Acceleration of the Drug Development Journey appeared first on PPD.

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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

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.

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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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Fierce BioTech

SEPTEMBER 13, 2024

Navigating today’s rapidly evolving clinical trial landscape can be tough. With intricate protocols and shifting regulatory demands, it’s more difficult than ever to find and keep participants, as well as gather reliable data.

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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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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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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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PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders.

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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

Quanticate

FEBRUARY 27, 2025

Wearable technologies have become a driving force in modern healthcare, transforming how data is collected, monitored, and analysed in clinical research.

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Clinical Trials Trials Clinical Research Research 52

PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. Patients are eager to participate in trials but remain largely unaware of their availability despite growing efforts to recruit. Virtual support can address some of these challenges cost-effectively.

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Clinical Trials Trials Clinical Research Research 92

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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Conversations in Drug Development Trends

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

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. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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Clinical Development Production Clinical Trials Treatment 69

Quanticate

APRIL 15, 2025

The Clinical Data Interchange Standards Consortium (CDISC) establishes globally recognised standards that ensure data accuracy, consistency, and compliance in clinical research.

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Clinical Research Research Clinical Trials Compliance 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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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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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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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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PPD

OCTOBER 31, 2024

From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends.

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Drug Development Clinical Trials Trials Drugs 52

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

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Your CRO can also play a crucial role in helping you to understand existing precedents and how they apply to your study and overall development journey.

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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

LifeSciVC

JULY 17, 2024

We are building on over a decade of extensive research on the genetic mutations associated with cystic fibrosis that originated at Genzyme and then continued at Sanofi, where our founding scientists discovered first-in-class correctors that in preclinical studies directly stabilized the first nucleotide-binding domain (NBD1) of the CFTR protein.

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PPD

FEBRUARY 10, 2025

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

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Clinical Trials Trials Clinical Research Research 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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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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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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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

MARCH 11, 2025

While individual rare diseases affect populations that are small in numbers, collectively they impact millions globally, posing significant health and research challenges. External comparator arms (ECAs): ECAs offer a viable solution to recruitment challenges by utilizing RWD to create control groups for single-arm 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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Clinical Research Research Clinical Trials Trials 52

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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Clinical Research Research Clinical Trials Trials 52

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

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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