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It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drugdevelopment. It demands a comprehensive, collaborative approach that reduces complexity and allows for just-in-time decision-making throughout the drugdevelopment journey. billion in 2023 to 1.2
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.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. 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.
The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drugdevelopment. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.
In every early phase clinicaltrial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success.
Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations.
Rigorous procedures to ensure that drugs are effective and safe. Regulatory bodies such as the FDA oversee clinicaltrials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws.
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.
Approaches to outsourcing clinicaltrials have changed significantly in recent years. Mixing of service models — a strategy that drugdevelopers are leveraging now more than ever — can bring life-changing therapies to market faster. Overseen by an insourced project manager.
It’s estimated that nearly three out of every four clinicaltrials are conducted by contract research organizations (CROs), highlighting just how much sponsors value — and rely on — the work that CROs perform. Surveys show that CROs improve trial efficiency and increase productivity.
Patients are the backbone of clinicaltrials, playing an essential role in the drugdevelopment process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
Simpler ClinicalDevelopment From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. With you in mind, we establish a clear and consistent path from drug discovery to delivery—one solution seamlessly connecting to the next.
Artificial Intelligence (AI) is poised to transform the field of target discovery in drugdevelopment, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds. Cavlan explains that “they are brilliant at developing and bringing new drugs to market.”
During the drugdevelopment process, companies have a choice of different approaches based on their development plan requirements. Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinicaldevelopment process.
In the rapidly evolving landscape of oncology drugdevelopment, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development. Lantern Pharma's RADR ® platform stands as a pivotal advancement in the fight against cancer.
Why is detecting cancers via liquid biopsy before they become visible on imaging important for drugdevelopment, not just diagnostics? We believe liquid biopsy is very helpful for oncology drugdevelopment because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.
A clinicaldevelopment plan — a comprehensive strategy for developing an investigational product through regulatory submission — is a critical component of drugdevelopment and helps ensure that new therapies are safe, effective, and of high quality.
The drugdevelopment industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drugdevelopment industry experienced setbacks during the COVID-19 pandemic, the field is again gaining momentum reminiscent of its pre-pandemic pace.
Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase ClinicalTrial Design: Project Optimus.” To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus. The key paradigm shift includes:
However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drugdevelopers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.
Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in ClinicalTrials ” that revises the 2006 guidance “Establishment and Operation of ClinicalTrial Data Monitoring Committees” and, when final, will replace the 2006 guidance.
A large majority of drugdevelopers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinicaldevelopment outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.
Last year, we witnessed a significant milestone in oncology clinicaldevelopment, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.
There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. Common challenges for certain patient groups include long-distance travel to clinical sites, time away from work and limited access to knowledge about CGT trials.
Recently, we have seen increasing numbers of complex FIH studies in CNS-active drugs to gather comprehensive data with a wider range of doses as early as possible. jpg Tags ClinicalTrials Weight 1
As Phase 1 clinicaltrials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), Click here to login.
4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drugdevelopment journey. Let the CRO know any key outcomes from each.
Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s ClinicalTrials Nexus, I had the privilege of representing Worldwide ClinicalTrials as the sole CRO on a panel discussion: “Reversing the Conversation: What the ClinicalTrial Industry Really Wants from its Service Providers.”
Introduction Worldwide ClinicalTrials vs. Vial. Worldwide ClinicalTrials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. How do they stack up? Other therapeutic areas include cell and gene therapy.
As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drugdevelopment shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinicaltrial landscape in 2024. Five Predictions for the DrugDevelopment Industry in 2024 1.
The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinicaltrials. However, Project Optimus emphasizes the importance of dose-finding studies in early clinicaldevelopment.
Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.
Meeting the never-ending challenges of drugdevelopment in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinicaldevelopment functions. are outsourced.
This has opened new opportunities in pharmaceutical drugdevelopment, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
Accelerating Global DrugDevelopment Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.
The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinicaldevelopment should emphasize sensitivity over specificity in CNS effects. Tags ClinicalTrials Weight 12 View the Driving Simulation Fact Sheet for more information.
Adaptive clinicaltrial topics are frequently explored in Perspectives on Enquiry and Evidence. Here are some of our most-read articles on adaptive clinicaltrials of 2022.
But commitment to neuroscience drugdevelopment is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles.
Welcome to the February 2023 Labcorp DrugDevelopment Decentralized ClinicalTrial (DCT) blog. With Rare Disease Day coming soon on February 28, we are going to focus on how patients, sites and investigators can benefit by improving the design and execution of rare disease trials. What is Rare Disease Day?
Data is the cornerstone of any clinicaltrial, driving the decision-making process of drugdevelopment, and is a fundamental requirement for approval of new therapies by regulatory agencies like the FDA or EMA.
As a provider of end-to-end clinicaldevelopment solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis. At Worldwide, we deliver full-service clinicaldevelopment to support drug approval and commercialization.
Combining Broad’s expertise in cancer biology and state-of-the-art drug discovery methods with Bayer’s expertise in drugdevelopment greatly increases our power to bring transformative medicines to cancer patients.” “We “Through this alliance, Broad and Bayer have done just that.
Contract research organizations (CROs) are an integral partner of the drugdevelopment process, as they play a pivotal role supporting clinicaltrial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinicaltrials are actually managed by these organizations?
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