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Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinicalresearch for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.
Clinicalresearch 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.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.
No matter how much technology we have, study success comes down to people and processes, says Wendy Tate, PhD, MS, Product Strategy Senior Director at Advarra. Clinicalresearch is a business that should focus on viable studies. Decisions can be supported using data already collected as part of the clinicalresearch enterprise.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinicalresearch? This new guidance will clearly impact the clinicalresearch field, but how? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development?
If theres one thing clinicalresearchers can count on when it comes to regulations and guidance from governing bodies, its change. Its a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country. This is a sponsored message.
Click here Diagnostics + Font Resize – NABL launches comprehensive training programme to enhance competence in reference material production Shardul Nautiyal, […]
In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research. Contact us today to learn more.
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA).
Oxford Medical Products has shared promising safety data from a first-in-human study for its ‘mechanical’ weight loss pill. Oxford’s device showed a favorable safety profile, with no serious adverse events reported, and no participants withdrew from the study due to product-related issues.
The clinicalresearch community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinicalresearch could change in 2021. On the path to better product development.
Also sharing advice on breaking free of unproductive habits on Saturday was Suzanne Kincaid, CCRA, ACRP-PM, FACRP, Consultant and Owner of Responsibility Research, in her session on “The Intersection of Technology and People: Harnessing Technology to Increase Efficiency and Build Relationships.” On Day Two of ACRP 2024 in Anaheim, Calif.,
The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)
These issues carry substantial personal and societal costs, impacting daily life and productivity. Despite advancements in neuroscience and psychiatry, clinical trials for mental health conditions such as major depressive disorder (MDD), schizophrenia, bipolar disorder and generalized anxiety disorder face unique challenges.
Exports of Ayush and herbal products have reported a growth of 20.33 per cent during the first month of the current fiscal year, at $51.44 million as compared to $42.75 million during the same month of previous fiscal year. Exports during the month of April, in Rupee terms, have reported a 21 per cent growth, […]
2024 has been a year of growth and evolution in clinicalresearch. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinicalresearch, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.
The Central Drugs Standard Control Organisation (CDSCO) has released an updated version of the guidance for Post Approval Changes in Biological Products, regarding the quality, safety and efficacy documents in order to align with the updated standards and digital formats developed after the previous version was rolled out. of […]
The demand for these medications, which play a vital role in managing diabetes and obesity, has far outpaced production capabilities, leading to widespread scarcity. The post Current ClinicalResearch Trends in GLP-1 (Glucagon-Like Peptide 1) Treatment appeared first on Worldwide Clinical Trials.
Exports of Ayush related products from the country have gone up around 53 per cent in five years from the financial year 2016-17 to 2020-21, according to the Ministry of Ayush. The imports, on the other hand, has increased around 42 per cent during the period, with a majority of the products based on the […]
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 clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
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. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.
The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]
In the turbulent waters of the clinicalresearch workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and around the worst of the storm. It required us to look at student frustrations in finding jobs in clinicalresearch,” Traynor says. “We
per cent of India’s Ayush and herbal products during the fiscal year 2023-24. The top 10 destinations led by USA, Germany and Italy accounted for almost 63.3 Exports to these 10 countries together stood at $412 million, with a growth of 5.10 per cent compared to the $392 million exports to top 10 destinations during […]
In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022.
Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinicalresearch. Xtalks spoke with Stacy Weil, DHI, Senior Vice President, Business Operations and Patient Centricity, Premier Research, to gain insights into incorporating DEI practices and plans in clinicalresearch.
a global leader in analytical and clinical laboratory technologies, announced that it has received two prestigious awards from SelectScience: Best New Drug Discovery & Development Product of 2023 and Drug Discovery & Development Webinar of the Year. Agilent Technologies Inc.,
In clinicalresearch, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products. This distrust is further compounded by a lack of visible accountability and representation in the research process.
It has transformed from a “nice-to-have” into a “must-have” part of the evidence package, helping to contextualize clinicalresearch and improve treatment understanding. In addition to utilizing RWE in clinicalresearch, there is a growing trend toward implementing RWE early in the product development lifecycle.
Clinicalresearch training for research-nave staff members can successfully enhance clinical trialreadiness at community cancer centers, according to the findings of a recent collaboration between Roche/Genentech, the Association of Cancer Care Centers (ACCC), and the Association of ClinicalResearch Professionals (ACRP).
There are still many unknowns around getting DTx products on the formulary and how to prescribe them to patients – doctors can’t just write a prescription and send patients off to the local drugstore when prescribing the use of an app. Self-Sovereign Identity- Decentralized Digital Identity and Verifiable Credentials. About the Author.
In the first of a five-part festive instalment of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Advarra’s chief product officer, Elisa Cascade, about the reasons behind increasing burdens on clinicalresearch sites over the last five years.
For example, many people who are just beginning to explore different roles in clinicalresearch find the duties of a clinicalresearch associate (CRA) very attractive (on paper, at least). The full article by Chew will appear in the August 2024 issue of ClinicalResearcher.
“Pediatric rare disease trials, by combining both the rarity of the rare disease as well as the restricted number of pediatric patients, do highlight some challenges,” said Dr. Gregory Hale, Senior Medical Director, Hematology and Oncology, of the global contract research organization (CRO) Medpace. Aspects of Pediatric Medical Research.
Speakers Dana Dailey PT, PhD Assistant Research Scientist Physical Therapy and Rehabilitation Science University of Iowa Associate Professor, Physical Therapy Department St. Dailey noted that clinicians felt more supported and seen as a part of both the clinic and the community.
Neurolens is a visual care and research company that aims to provide patients with visual acuity and visual comfort. Neurolens recently announced study results which show that Neurolenses have a significant impact on reading speed and these new results have implications for learning and productivity.
The benefits of diversity and inclusion in clinicalresearch are widely recognized, yet the financial and operational costs of these efforts are often overlooked. Another hidden cost is training and education for research teams, says Mitchell Hilbe, CEO/Co-Founder at DiversiTrials. View complete schedule.
The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, (..)
Velocity ClinicalResearch, the leading multi-specialty clinicalresearch organization, has partnered with Verified Clinical Trials (VCT) to set a new benchmark for patient safety and data quality in clinical trials through a new technological implementation at Velocitys 80+ global sites.
As cannabis legalisation spreads, so too does medical research into all the benefits we can derive from THC, CBD, and the various terpenes to be found in the cannabis flower. In research as in cryptocurrency, even the slightest inconsistency could be disastrous. What is blockchain? Security, redundancy, transparency.
Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinicalresearch and drug development issues. The strategy outlined several measures to address the country’s declining role in global clinical trials, safeguard pharmaceutical supply chains, speed up approvals, and reduce bureaucracy.
Some research suggests that optimized microfluidic devices can isolate rare CTCs with recovery rates exceeding those of conventional methods sometimes reaching over 90% under ideal conditions. These rigorous tests support the technologys potential to deliver reliable, accurate results in clinical settings.
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