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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.
Click here Diagnostics + Font Resize – NABL launches comprehensive training programme to enhance competence in reference material production Shardul Nautiyal, […]
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.
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.
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?
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) (..)
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, […]
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.
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 […]
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.
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 […]
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 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.
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 […]
If theres one thing clinicalresearchers can count on when it comes to regulations and guidance from governing bodies, its change. The Academy agenda covers: Human research protections U.S. Learn more about HCCA The post Keeping Up with the ClinicalResearch Compliance Landscape appeared first on ACRP.
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.
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.,
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.,
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.
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.
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.
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.
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 The post How to Weather the ClinicalResearch Talent Recruitment Storm appeared first on ACRP.
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 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, (..)
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.
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.
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.
It’s also full of recommendations or advertisements for products that can protect you. Social media is full of claims that everyday habits can harm your skin. Now social media has blue light from our devices in its sights. So can scrolling on our phones really damage your skin? And will applying creams or lotions help? […]
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma.
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.
The benefits of diversity and inclusion in clinicalresearch are widely recognized, yet the financial and operational costs of these efforts are often overlooked. The Hidden Costs of Diversity and Inclusion in ClinicalResearch Join MaryAnn and Mitchell at ACRP 2025 [April 24-27 ; New Orleans, La. ]
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. We are proud of our clinical foundation and will never stop challenging ourselves. What are the short-term goals for Neurolens?
The webinar concluded with Kyle Haas, Associate Director, Clinical Trial Management, Medpace, speaking about the operational and study start-up considerations for pediatric rare disease clinicalresearch. Aspects of Pediatric Medical Research. Challenges in Pediatric Rare Disease Clinical Trials.
The artificial sweetener sucralose (marketed as Splenda) is widely used and found in products like diet soda and chewing gum. According to a new study, it’s also capable of damaging the DNA material inside our cells.
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. Additionally, both the A+Pre and AC-1000 devices have secured clearance from Chinas National Medical Products Administration (NMPA).
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.
Care-Keralam, the Ayush cluster in Kerala, will shortly fine-tune its strategies to build ‘Kerala Brand of Ayurveda Products’ for international marketing and to increase the quantity of exports of traditional and herbal drugs from Kerala to global markets.
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.
Elisa Cascade is the chief product officer at Advarra and is responsible for driving the clinicalresearch company's technology product vision and management. We had a fascinating and inspiring conversation with her - touching on imposter syndrome, how to avoid suffering in silence and her 'just do it' mantra.
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.
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