Imperical Blog

MARCH 6, 2024

Get 3 tips to make your clinical trial team agile and proactive in the ever-evolving world of clinical studies. Clinical trial teams navigating today’s dynamic landscape face a multitude of risks due to the ever-increasing pace of change. These risks can include: Technological advances rapidly… The post 3 Tips to Make Your Clinical Trial Teams Agile and Proactive appeared first on Imperial Clinical Research Services Blog.

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Clinical Trials Clinical Trials Trials Clinical Research 52

WCG Clinical

MARCH 6, 2024

This content is password protected. To view it please enter your password below: Password: The post Creating Partnerships: Aligning Vendor Support for Success in Clinical Research appeared first on WCG.

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Clinical Research Research 40

FDA Law Blog

MARCH 7, 2024

By Mark A. Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Clinical Trials Trials Regulation 105

Rethinking Clinical Trials

MARCH 7, 2024

Dr. Stephanie Morain In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results by relevant decision-makers.

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Clinical Trials Clinical Trials Trials Scientist 317

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Pharmaceutical Technology

MARCH 4, 2024

For Rare Disease Day, several panels organised by the FDA discussed the importance overcoming accessibility barriers during drug development.

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Research Development Drugs 195

Pharmaceutical Commerce

MARCH 6, 2024

Navigating the complex landscape of healthcare coverage can be an intimidating task, especially for patients with rare diseases for which treatments often come with a high price tag.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2024

Oncologists during clinical trials of paediatric cancer cases are seen to encounter parent reluctance. Viewed as a significant challenge, cancer care centres have observed that it comes in because of hesitancy by parents to enroll their children.

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Clinical Trials Clinical Trials Trials Clinical Research 186

CTTI (Clinical Trials Transformation Initiative)

MARCH 5, 2024

Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov The post Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov appeared first on CTTI.

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Pharmaceutical Technology

MARCH 7, 2024

The challenges and opportunities surrounding Africa becoming a clinical trials global force were discussed on day one of CTS Europe.

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Clinical Trials Clinical Trials Trials 130

Bio Pharma Dive

MARCH 8, 2024

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

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Drugs Marketing 344

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 6, 2024

Tiny fragments of microplastics are making their way deep inside our bodies in concerning quantities, significantly through our food and drink. Scientists have now found a simple and effective means of removing them from water.

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Scientist Clinical Trials Clinical Trials Clinical Research 246

Rethinking Clinical Trials

MARCH 6, 2024

In this Friday’s PCT Grand Rounds, Michael Pencina of Duke University will present “Public-Private Partnerships in the Trustworthy Health AI Ecosystem.” The Grand Rounds session will be held on Friday, March 8, 2024, at 1:00 pm eastern. Pencina is a professor of biostatistics and bioinformatics and the vice dean for data science in the Duke University School of Medicine.

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Bioinformatics Clinical Trials Clinical Trials Scientist 173

Pharmaceutical Technology

MARCH 6, 2024

Demand for medicinal cannabis is increasing globally to treat a range of illnesses and conditions.

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Medicine 340

Bio Pharma Dive

MARCH 7, 2024

The startup, which has raised nearly $254 million privately, is in early testing with drugs designed to target particularly tough-to-treat tumors.

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Drugs 312

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

What’s good for your aging gut may also be good for your aging brain. The first twin study of its kind suggests that taking daily protein and prebiotic supplements can improve scores on memory tests in people over the age of 60.

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Protein Clinical Trials Clinical Trials Clinical Research 241

Rethinking Clinical Trials

MARCH 5, 2024

The NIH Pragmatic Trials Collaboratory will offer a preconference workshop at the 45th Annual Meeting of the Society for Clinical Trials in Boston. Registration for the workshop is now open. The workshop, “Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on engaging stakeholders and

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Trials Clinical Trials Clinical Trials Clinical Research 162

Pharmaceutical Technology

MARCH 8, 2024

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

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Drugs 299

Bio Pharma Dive

MARCH 8, 2024

The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval.

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Medicine Drugs 310

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

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) and current […]

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Production Drugs Clinical Trials Clinical Trials 240

Fierce Pharma

MARCH 6, 2024

AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing a big chunk of money into the Big Pharma’s home country. | AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing £650 million into the Big Pharma’s home country.

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Life Science Vaccine Vaccination 145

Pharmaceutical Technology

MARCH 8, 2024

Johnson & Johnson (J&J) has concluded the acquisition of Ambrx Biopharma in a transaction valued at approximately $2bn.

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Bio Pharma Dive

MARCH 7, 2024

Early results from a Phase 1 study suggest the drug, amycretin, could be as potent as injectable medicines already sold by Novo and rival Eli Lilly.

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Trials Medicine Drugs 306

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 5, 2024

The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinical trials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).

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Clinical Trials Clinical Trials Drugs Regulation 233

pharmaphorum

MARCH 4, 2024

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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Clinical Trials Clinical Trials Trials 145

Pharmaceutical Technology

MARCH 4, 2024

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

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Bio Pharma Dive

MARCH 5, 2024

The study results further validate Roche’s recent decision to acquire rights to the drug, which is being developed for people with a stubborn form of hypertension.

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Drugs Trials Development 306

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 7, 2024

Could Alzheimer’s disease one day be treated by flashes of light and clicks of sound? Scientists have now demonstrated how stimulating high-frequency brain waves in mice can clear out the amyloid protein clumps associated with Alzheimer’s.

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Protein Scientist Research Clinical Trials 229

Fierce Pharma

MARCH 8, 2024

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. | The drug is the first weight loss treatment to win FDA approval to reduce the risk of severe cardiovascular outcomes, giving it an edge over rival Zepbound from Eli Lilly.

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FDA Approval Drugs 136

Pharmaceutical Technology

MARCH 8, 2024

The FDA has already granted accelerated approvals to several third-line treatments, with big pharma being prominent in the landscape.

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FDA Approval 264

Bio Pharma Dive

MARCH 7, 2024

The results from the privately held biotech add to early evidence supporting the potential of an increasingly popular drug target known as NLRP3 inflammasomes.

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Drugs 299

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials