This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Decentralized clinicaltrials (DCTs) bring many benefits to the clinicalresearch process, and more importantly, the patients. However, it is important to remember the risks if there is no data security process in place.
As clinicaltrials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinicaltrial management.
Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinicaltrials, which judiciously test and evaluate safety and efficacy.
Clinicalresearch 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.
ClinicalResearch Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drug development process and conducting clinicaltrials. In this […] The post ClinicalResearch Organizations: Importance, Services, Selection Process and Future.
The EU AI Act’s implications extend into clinicalresearch, 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 clinicaltrials.
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 clinicaltrials. A high-risk participant can be even excluded from the study based on the severity of the adverse event.
For many people, participating in a research study presents an interesting opportunity with many benefits to volunteering. While there are many types of clinicalresearch, all with distinct goals and timelines, trial volunteers will follow a similar path when taking part. Read on to learn more about the process.
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 clinicaltrials.
Navigating today’s rapidly evolving clinicaltrial 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.
There are many clinicaltrial 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.
Accelerate your drug development and clinicaltrial 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.
In an era where clinicaltrials 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 clinicaltrial’s safety and efficacy.
Redefining vaccine trial recruitment Clinicaltrials are vital for developing safe and effective vaccines, but their success relies on overcoming recruitment challenges and ensuring diverse study cohorts. Discover innovative, data-driven recruitment strategies to ensure diverse, efficient, and high-quality vaccine trials.
Connecting patients with clinicalresearch 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 clinicaltrial but to do this effectively, it’s critical to have accurate information.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Wearable technologies have become a driving force in modern healthcare, transforming how data is collected, monitored, and analysed in clinicalresearch.
Acceleration in every step of clinicalresearch is critical to pharmaceutical developers. Yet, today’s clinicalresearch sponsors face significant challenges. Rather than accepting the persistent delays in clinicalresearch as disruptive, yet unavoidable, we believe they underscore the need for greater efficiency.
Achieving diversity, equity, and inclusion (DEI) in clinicaltrials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinicalresearch encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.
Before any new medical treatment, therapy, or device is approved, it must first be tested through clinicalresearch studies. While some research studies seek participants with illnesses or conditions to be studied in the clinicaltrial, it is not always necessary to have a specific illness or condition to participate.
The term Functional Service Provider (FSP) concept is highly regarded in the field of clinicalresearch. With drug discovery and clinicaltrials becoming more complex, pharmaceutical firms and research organizations are searching for flexible and customized solutions.
Clinicaltrials 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 ClinicalResearch appeared first on ProRelix Research.
In recent years, the landscape of clinicaltrials has evolved significantly, particularly in oncology research. Two innovative trial designs that have gained prominence in Phase II are the basket and umbrella designs.
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.
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.
The COVID-19 pandemic rapidly accelerated the adoption of hybrid and decentralized clinicaltrial (DCT) models. At the end of 2022, the PPD clinicalresearch business of Thermo Fisher Scientific surveyed key leadership and staff on the frontline of clinicaltrial execution across the industry.
From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinicaltrials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.
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 ClinicalResearch in Rare Diseases appeared first on LifeSciVC.
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 clinicaltrials. There’s little time to lose.
Clinicaltrials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. A clinicaltrial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV.
Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinicaltrial design is crucial for executing successful clinicalresearch. These data emphasize the need for precise and meaningful body composition endpoints in T2D and obesity clinicaltrials.
The field of clinicalresearch is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinicalresearch conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.
IWRS, IVRS, and IRT systems are an important part of the clinicalresearch process, as they are used to manage patient enrollment, randomization, drug supply, reporting, and more during clinicaltrials.
By partnering with a contract research organization (CRO) that understands the challenges of liver disease clinicaltrials — 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.
Advancements in preclinical and clinicalresearch 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.
Participating in a clinicalresearch study can have many benefits. From offering specialized care to providing participants with potential new treatment options, finding the right clinicaltrial can lead to positive outcomes for today’s patients and unlock breakthroughs for those diagnosed in the future.
Distinguishing the Roles of Preclinical vs. Clinical CROs in ClinicalResearch Randomized clinicaltrials 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
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.
According to GAO, FDA is facing challenges with clinicalresearch 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 clinicalresearch.
Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinicaltrial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2
Clinicaltrials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinicaltrials requires efficient communication and coordination among various stakeholders.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content