Pharmaceutical Technology

DECEMBER 27, 2022

Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Still, the country’s clinical trials sector remains insular. Tracking the news. Tracking drug development. Tracking the diversity push.

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Cloudbyz

APRIL 9, 2024

Medical devices play a critical role in healthcare, but ensuring their safety and reliability can be a complex and challenging task. The medical device industry is constantly evolving, and with that evolution come new and complex safety issues.

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Clinical Trials Clinical Trials Compliance Trials 65

Antidote

APRIL 4, 2024

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

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Clinical Trials Clinical Trials Trials Marketing 119

XTalks

APRIL 25, 2024

Heart failure, affecting over 64 million people worldwide , remains a formidable challenge in the medical community despite advancements in pharmacotherapy over the past decade. Kereiakes, MD, FACC, MSCAI, Vice President of the Medical Department at Medpace. In the webinar, Dr. Adam M. The webinar concluded with Dr. Dean J.

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Pharmaceutical Technology

APRIL 26, 2023

But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

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Clinical Trials Clinical Trials Allergies Research 289

Cloudbyz

MAY 17, 2024

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

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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. Firsthand experiences with embedded pragmatic clinical trials and case studies from the NIH Pragmatic Trials Collaboratory will support and illustrate the topics presented.

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Trials Clinical Trials Clinical Trials Clinical Research 159

Antidote

SEPTEMBER 25, 2023

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.

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Clinical Trials Clinical Trials Trials Marketing 128

Pharma Mirror

JUNE 15, 2023

In recent years, the field of clinical trials has witnessed a significant transformation due to advancements in technology. The integration of technology into clinical trials has revolutionized the way researchers conduct studies, collect data, and analyze results.

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Clinical Trials Clinical Trials Trials Research 130

FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

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Production Trials Marketing Pharmacy 111

Antidote

NOVEMBER 9, 2023

Before any new treatment or therapy is able to be used by the patient population, it must go through the process of a clinical trial — this is the case for any new prescription drug, but also true for over-the-counter medications, medical devices, and more.

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Clinical Trials Clinical Trials Trials Drugs 126

BioTech 365

AUGUST 31, 2021

Bn Clinical Trial Supplies Markets by Services (Manufacturing, Packaging, Logistics, Distribution), Phases (I to IV), Type (Small molecule, Biologics, Medical Devices) – Global Forecast 2026 – ResearchAndMarkets.com $2.9

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ProRelix Research

MAY 31, 2023

Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they […] The post Successful Clinical Trial With ProRelix Research: Phase 1, 2, 3 & 4 Clinical Trial Services at … appeared (..)

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Clinical Trials Clinical Trials Trials Research 98

Antidote

SEPTEMBER 13, 2023

Globally, there are thousands of research studies and clinical trials conducted each year, all with the shared goal of bringing new treatment options and medical devices to the market. However, approximately 80% of clinical trials are delayed or closed because of problems with recruitment.

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Clinical Trials Clinical Trials Trials Marketing 98

Cloudbyz

JUNE 7, 2023

The medical technology (MedTech) industry has been witness to revolutionary changes over the last few years. This blog post delves into how RWE is transforming clinical operations within the MedTech landscape. Let’s explore how RWE is reshaping clinical operations in MedTech. What is Real-World Evidence?

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Clinical Trials Clinical Trials Trials Marketing 80

ProRelix Research

NOVEMBER 2, 2023

Although clinical trials provide useful information regarding the efficacy and safety of new drugs, biological products, and medical devices, the information captured through them is not all-encompassing.

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Marketing Clinical Trials Clinical Trials Production 98

XTalks

MARCH 27, 2024

Dhiman has 24 years of clinical research experience in the immunogenetics of vaccines and infectious disease diagnostics. She did her clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota. The ability to deliver samples, space, devices, staffing and a robust infrastructure sets Quest apart.

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Manufacturing Clinical Trials Clinical Trials In-Vitro 108

XTalks

JULY 7, 2022

Lenire is a non-invasive, bimodal neuromodulation device that works by using two paired stimuli to stimulate nerves for tinnitus treatment. Photo courtesy Neuromod Devices Ltd. There are also medical conditions that can contribute to ringing in the ears, such as age-related hearing loss, high blood pressure and high cholesterol.

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Clinical Trials Clinical Trials Trials Development 105

Antidote

AUGUST 21, 2023

Before any new treatment is able to be approved, it is required to go through the vigorous testing process known as clinical trials. These trials are aimed at determining whether or not a drug, medical device, therapy, or other type of intervention is safe and effective for the public.

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Clinical Trials Clinical Trials Trials Drugs 98

XTalks

NOVEMBER 27, 2023

Solving the opioid epidemic long-term requires bringing new, safe and better treatments to market to replace the reliance on opioids in the clinical setting. Despite the challenges, promising investigational products for pain management are entering into trials.

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Clinical Trials Clinical Trials Trials Clinical Research 102

FDA Law Blog

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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Antidote

JUNE 7, 2023

Before any new medical treatment, therapy, or device is approved, it must first be tested through clinical research studies. While some research studies seek participants with illnesses or conditions to be studied in the clinical trial, it is not always necessary to have a specific illness or condition to participate.

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Research Clinical Trials Clinical Trials Clinical Research 98

Pharmaceutical Technology

OCTOBER 13, 2022

Based in Colleretto Giacosa, Italy, AorticLab’s innovative embolic protection device ‘Flower’ uses exclusive ‘Catch & Flow’ technology which combines cutting-edge design with an ultra-fine mesh. This new device is designed to reduce incidences of stroke by removing more debris from the patient during TAVI. Partnering with Sefar.

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Clinical Trials Clinical Trials Marketing Engineer 130

ProRelix Research

DECEMBER 27, 2022

Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care […]. The post USA Clinical Trial Market Size and Opportunities appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Marketing 98

Rethinking Clinical Trials

SEPTEMBER 13, 2023

Two devices are commonly used to perform tracheal intubation, direct laryngoscope and video laryngoscope. The DEVICE trial hypothesized that the use of a video laryngoscope will increase the incidence of successful intubation on the first attempt. For the RSI trial the FDA regulations had not been updated yet.

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Trials Clinical Trials Clinical Trials Medicine 146

ProRelix Research

APRIL 5, 2023

Clinical trials form the decisions for regulatory approval of drugs and medical devices and as a result are the most important step of a drug development program.

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Trials Clinical Trials Clinical Trials Drugs 98

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

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Clinical Trials Clinical Trials Trials Dermatology 130

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. million people in the UK and 2.7

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Clinical Trials Clinical Trials Marketing Development 354

Antidote

OCTOBER 7, 2022

Different types of clinical studies are designed to investigate potential therapies, medications, and medical devices — and all of these must go through each phase of a clinical trial before they are approved.

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Research Clinical Trials Clinical Trials Trials 98

Cloudbyz

JANUARY 4, 2024

The development of medical devices is a meticulous process, spanning from initial pilot trials to post-market surveillance. A critical aspect of this journey is the reporting of adverse events (AEs), ensuring the safety of patients and contributing to the overall success of the device.

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Trials Marketing Compliance Regulation 59

ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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FDA Compliance Compliance Clinical Trials Clinical Trials 52

Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials.

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Clinical Trials Clinical Trials Trials Regulation 64

Olympian Clinical Research

MARCH 19, 2024

Clinical trials are essential for advancing medical knowledge and developing new treatments that can improve patient care and outcomes. In Tampa Bay, Olympian Clinical Research is at the forefront of this vital work, offering local residents the opportunity to contribute to medical advancements.

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Clinical Trials Clinical Trials Trials Clinical Research 52

ProRelix Research

NOVEMBER 14, 2023

The growing impetus for the conduct of clinical trials outside the United States for products and medical devices intended to be used in the US include multiple reasons such as […] The post US FDA Foreign Clinical Trial Data Requirements appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Production 52

Rethinking Clinical Trials

JUNE 15, 2023

This year’s Annual Steering Committee Meeting for the NIH Pragmatic Trials Collaboratory featured two special guests from the U.S. Food and Drug Administration’s Digital Health Center of Excellence—Matthew Diamond, MD, PhD, Chief Medical Officer, and Sonja Fulmer, PhD, Acting Deputy Director.

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Pharmaceutical Technology

NOVEMBER 22, 2022

This approval under the emergency regulatory approval system is granted under the Article 14-2-2 of the Pharmaceuticals and Medical Devices Act, the company noted. The latest development is based on the expected efficacy of the drug and the acceptability of its safety profile reported from a Phase II/III clinical trial.

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Drugs Clinical Trials Clinical Trials Sales 246

ProRelix Research

OCTOBER 12, 2023

Clinical trials are critical for the approval of new drugs and medical devices necessitating that data that is derived from them to make regulatory decisions is done so in a […] The post FDA’s Clinical Data Standard Requirements for Clinical Trials appeared first on ProRelix Research.

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Clinical Trials Clinical Trials Trials Drugs 52