Imperical Blog
NOVEMBER 28, 2023
Clinical trial labeling is complex. Discover how Imperial CRS helped a client overcome some of the complexities of this critical clinical trial component. Did you know that product labels are big business? Labels are a lively commercial niche, and the global market for pharmaceutical labels… The post Clinical Trial Labeling: Don’t Get Stuck appeared first on Imperial Clinical Research Services Blog.
pharmaphorum
NOVEMBER 27, 2023
Cultivating quality excellence in the clinical trials landscape Mike.
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Antidote
NOVEMBER 29, 2023
Interactive Response Technology (IRT) is an umbrella term that includes Interactive Web Response (IWRS) and Interactive Voice Response (IVRS) systems. These tools serve a critical role in ensuring clinical trials run smoothly, and as technologies develop, their capabilities only continue to expand.
XTalks
NOVEMBER 30, 2023
Patient-centric co-design refers to an approach where patients or end-users are actively involved with healthcare professionals, designers and other stakeholders to develop healthcare services or products. It allows for the creation of more effective, accessible and user-friendly healthcare solutions that align with the actual needs and desires of patients.
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
pharmaphorum
NOVEMBER 28, 2023
Putting patients at the centre of innovation starts with clinical trial access Mike.
Outsourcing Pharma
NOVEMBER 29, 2023
Professor Deborah Ashby, interim Dean of the Faculty of Medicine, Imperial College, delivered this yearâs Sally Hollis Memorial Lecture. OSP enjoyed a discussion with both her and Professor Jennifer Visser-Rogers, vice-president for statistical research and consultancy at Phastar, about how new approaches to clinical trials are changing data monitoring committees.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
NOVEMBER 29, 2023
In this discussion with Dr. David Cameron, Chair of the Breast International Group (BIG) , we delve into the landscape of breast cancer research today, clinical trials and the incorporation of the patient voice in breast cancer research. With a vast repository of knowledge and expertise in international clinical trials, Dr. Cameron’s insights offer a valuable understanding of where we stand in breast cancer research today.
pharmaphorum
NOVEMBER 27, 2023
Held at London’s Battersea Arts Centre on 5th October, Sanofi’s ‘What If?’ People’s Poem event coincided with National Poetry Day.
Bio Pharma Dive
NOVEMBER 28, 2023
U.S. tax law changes enacted six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.
Pharmaceutical Technology
NOVEMBER 29, 2023
Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.
Worldwide Clinical Trials
NOVEMBER 27, 2023
By: Amy Raymond, PMP, PhD, Senior Director, Therapeutic Strategy Lead, Cellular & Genetic Medicines On November 16, the British regulatory body, Medicines and Healthcare products Regulatory Agency (MHRA) approved exagamglogene autotemcel (exa-cel) to treat severe sickle cell disease for patients ages 12 and up, becoming the first gene editing treatment to receive regulatory approval.
Rethinking Clinical Trials
NOVEMBER 29, 2023
In this Friday’s PCT Grand Rounds, Jim Hughes of the University of Washington will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Guidelines for Design and Analysis of Stepped-Wedge Trials.” The session will be held on Friday, December 1, at 1:00 pm eastern. Hughes is a professor emeritus of biostatistics at the University of Washington.
Bio Pharma Dive
NOVEMBER 28, 2023
The agency said the benefit of approved treatments like Gilead’s Yescarta still outweighs any such risk, but the alert could slow drugmaker efforts to develop the treatments for wider use.
Pharmaceutical Technology
NOVEMBER 30, 2023
As more cell and gene therapies get approved to treat common conditions, scaling them up will be a challenge.
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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
Pharma Times
NOVEMBER 29, 2023
The new state-of-the-art facility is set to be operational in early 2024 - News - PharmaTimes
Rethinking Clinical Trials
NOVEMBER 28, 2023
The workshop summary is now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.
Bio Pharma Dive
NOVEMBER 29, 2023
Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role.
Pharmaceutical Technology
NOVEMBER 28, 2023
The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.
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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.
Pharma Times
DECEMBER 1, 2023
Every year, over 44,000 men are diagnosed with prostate cancer in England - News - PharmaTimes
Rethinking Clinical Trials
NOVEMBER 27, 2023
The National Institutes of Health’s Office of Disease Prevention (ODP) issued a new funding opportunity to support implementation studies in treatment and prevention for alcohol, tobacco, and other drugs use and misuse in adult populations that experience health disparities. ODP and participating NIH Institutes and Centers are inviting applications for research projects that test innovative approaches to implementing screening, brief intervention, and referral to treatment or prevention fo
Bio Pharma Dive
NOVEMBER 29, 2023
Drawn-out negotiations led to a lower price than initially expected, but analysts called the agreement a step forward for the biotech company.
Pharmaceutical Technology
NOVEMBER 28, 2023
The emergency use listing is based on non-clinical data where the vaccine demonstrated immune responses against variants in SARS-CoV-2.
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.
Fierce Pharma
NOVEMBER 30, 2023
With layoffs hitting employees on both sides of the Atlantic, Pfizer’s $3.5 billion cost-cutting spree has kicked it into high gear this month. | The company's Groton, Connecticut, research site is the latest to fall victim to job cuts as part of Pfizer's massive $3.5 billion cost-cutting mission, following layoffs across the U.S. and the U.K.
Rethinking Clinical Trials
NOVEMBER 30, 2023
The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2024 Annual Conference until December 11, 2023. This year’s meeting will be held in Milwaukee, Wisconsin, from April 9 to 11, 2024. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems.
Bio Pharma Dive
NOVEMBER 29, 2023
The cuts will impact 7% of the cancer drug division’s employees, although about 90 new roles will be created around “areas of growth.
Pharmaceutical Technology
NOVEMBER 29, 2023
The agency has received reports of T-cell malignancies in patients who have previously received CAR-T cell immunotherapies.
Fierce Pharma
NOVEMBER 28, 2023
In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.
Pharma Times
NOVEMBER 27, 2023
The IRP will bring life-saving medicines to UK patients from 1 January 2024 - News - PharmaTimes
Bio Pharma Dive
NOVEMBER 27, 2023
One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.
Pharmaceutical Technology
DECEMBER 1, 2023
Partnership deals involving psychedelic drugs saw a 500% growth in total deal volume from 2019 to 2023 year-to-date (YTD).
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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.
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