Advarra

MARCH 6, 2025

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

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Advarra

MARCH 7, 2025

Clinical research is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. It is the foundation of medical innovation.

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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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Clinical Research Research Clinical Trials Drug Development 97

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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Clinical Trials Trials Clinical Research Research 122

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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Clinical Research Research Clinical Trials Compliance 98

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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Clinical Research Clinical Trials Research Trials 98

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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Drug Development Clinical Trials Drugs Small Molecule 97

ProRelix Research

MAY 13, 2025

The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades.

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Clinical Trials Compliance Regulations Trials 52

Quanticate

JUNE 13, 2025

Clinical research generates vast amounts of diverse data from laboratory tests, patients, medical equipment, and outside sources. By organising and analysing this information, researchers can extract actionable insights that improve patient outcomes, data accuracy, drug efficacy and speed up trials.

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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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Clinical Research Research Clinical Trials Packaging 98

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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Clinical Trials Trials International Clinical Research 97

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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Clinical Research Clinical Trials Research Trials 97

ProRelix Research

MAY 14, 2025

In the ever-advancing field of pharmaceutical development, regulations surrounding drug clinical trials in the United States serve a critical purpose.

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Clinical Trials Regulations Trials Drugs 52

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

Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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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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Clinical Research Research Clinical Trials Trials 98

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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Clinical Trials Trials Research Clinical 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

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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Clinical Trials Trials Compliance Clinical Research 97

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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Clinical Trials Trials Clinical Research Doctors 86

PPD

JANUARY 2, 2025

FSP solutions are being more frequently utilized by biotech companies Biotech companies employ contract research organizations (CROs) to handle trial-related functions and services, often delivered through a full-service outsourcing (FSO) model, an FSP model or a mixed model combining both. FSP outsourcing is growing faster than FSO.

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Clinical Development Clinical Trials Trials Regulations 98

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

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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Clinical Trials Regulations Trials Clinical Research 96

FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. Below, we explore some of the key themes seen in the changes.

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Clinical Trials Trials Clinical Research Government 88

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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Clinical Research Disease Research Clinical Trials 81

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

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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Clinical Trials Trials Compliance International 98

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

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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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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