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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Clinicaltrials 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.
Global expertise and 7 key lessons learned The PPD clinicalresearch business of Thermo Fisher Scientific has extensive history working with PAH clinicaltrial sites globally (more than 3,500 sites across 53 countries in the past five years). From that experience, we offer seven key takeaways.
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.
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.
Wearable technologies have become a driving force in modern healthcare, transforming how data is collected, monitored, and analysed in clinicalresearch.
Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinicaltrial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinicalresearch business of Thermo Fisher Scientific. There’s little time to lose.
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.
The European Union ClinicalTrial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU ClinicalTrials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.
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.
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
“Patient-centric” is used frequently to describe today’s clinicaltrial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinicaltrial designs. Patient centricity has become more than a key consideration.
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.
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 clinicalresearch business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends.
Over the last decade, the clinicalresearch 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 clinicaltrial experience.
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.
The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinicalresearch and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinicaltrials and introduce automation in drug discovery.
Clinicaltrials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. Participating in a clinicaltrial 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.
In clinicalresearch, innovations in technology are moving us down an exciting path, transforming traditional methodologies and paving the way. The post Wearables in ClinicalTrials: Real Benefits Beyond the Hype appeared first on Crucial Data Solutions.
Written by Angela Vinken and Patti Arsenault Key Opinion Leaders (KOLs) — i.e., trusted, well-respected experts — are crucial in clinicalresearch, especially in rare diseases. The challenge, however, is how to use KOLs wisely — they are often clinicians first and researchers second, and their time is in high demand.
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.
The success of clinicaltrials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Specifically, U.S. Patients underlined the need for transparency by pharma and other related companies to build trust and partnership.
For clinicalresearch 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.
Strategic Site Identification for ClinicalTrials blussier Mon, 11/18/2024 - 21:10 HTML Start Your Study Faster Watch our latest podcast to discover Altasciences' unique process for identifying and selecting the right clinical sites for your unique project. WATCH NOW Book a visit ; we’d love to host you!
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.
Tissue biopsies have long been a cornerstone of clinicalresearch, providing researchers with direct access to diseased and healthy tissue for analysis. In recent years, their role in clinicaltrials has expanded, offering invaluable insights into disease mechanisms, drug efficacy and personalised treatment strategies.
Its important for your clinicalresearch organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.
Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinicalresearch. PROs in clinicaltrials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated.
Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinicaltrials. Developing effective ECs requires more than just matching clinicaltrial inclusion and exclusion criteria within the RWD source.
The Sustainable Healthcare Coalition , a not-for-profit, health care sector-led group based in the United Kingdom, concluded that globally, clinicalresearch 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.
The Sustainable Healthcare Coalition , a not-for-profit, health care sector-led group based in the United Kingdom, concluded that globally, clinicalresearch 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.
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