VirTrial

AUGUST 21, 2021

A telemedicine platform intended for clinical trials must provide broader functionalities to accommodate the various needs of sponsors, CROs, patients, clinicians, investigators, research site staff, and regulators, as well as meet international regulatory requirements. Multi-party encrypted calendaring.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

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Drug Discovery World

MARCH 23, 2023

A series of new measures will be introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to make it faster and easier to gain approval and run clinical trials in the UK. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.”

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.

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Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+ Dr Olena Karpenko.

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Rethinking Clinical Trials

OCTOBER 27, 2022

Duke Clinical Research Institute. Chief Research Technology Strategist. Duke University School of Medicine . ePatient and Security Researcher. Patients use the internet to search for answers, and researchers use the internet to search for new solutions. Eric Perakslis, PhD. Andrea Downing.

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ACRP blog

JULY 5, 2023

Under-representation of diverse groups in the clinical research workforce contributes to the under-representation of diverse clinical trial participants. To grow and diversify the clinical research workforce, Merck (known outside the U.S.

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ACRP blog

JULY 5, 2023

Under-representation of diverse groups in the clinical research workforce contributes to the under-representation of diverse clinical trial participants. To grow and diversify the clinical research workforce, Merck (known outside the U.S.

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Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

DECEMBER 19, 2022

The recommendations are part of the ACT EU initiative between the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) group – launched earlier this year – intended to further develop the EU’s role as a centre for clinical research.

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Drug Discovery World

OCTOBER 16, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has revealed plans to reduce the time taken to approve the lowest-risk clinical trials by more than 50%. The scheme is based on that outlined in the MHRA’s clinical trials consultation which was endorsed by 74% of those who responded.

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Drug Discovery World

JANUARY 23, 2024

Sano Genetics, a software company working to accelerate precision medicine research, has raised $11.4 Access and referrals for patients to join trials often depend on the hospital or location where they’re receiving treatment – which is why recruiting for clinical trials is one of the biggest challenges in research.

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Pharmaceutical Technology

FEBRUARY 24, 2023

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Post-marketing research is a generic term used to describe all activities after drug approval by the regulatory agencies, such as the Food and Drug Administration (FDA). Post market research for monitoring drug safety. Why are Post- Marketing studies conducted.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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Medicine Scientist Production Regulation 52

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 23, 2023

With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.

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Pharmacy Sales Licensing Licensing 143

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 19, 2023

Taking into account the four main components of regulator, industry, trade and patient/consumer in a medicine value supply chain, the Drugs and Cosmetics (D&C) Rules, 1945 and D&C Act, 1940 needs an urgent revamp as there is no clause of compensation for ADRs in patients, according to drug regulatory experts.

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ACRP blog

FEBRUARY 29, 2024

Education and training remain key elements in the development and professionalization of the clinical research workforce. 1,2} Two research-intensive academic medical centers (AMCs) are seeing benefits from competency-based job classifications. We needed a way to standardize our clinical research staff hiring process.

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Find Me Cure

OCTOBER 3, 2019

If you follow our blog, you know that we like to clear confusion about clinical trials. Also called clinical research studies, they don’t just test drugs. There are clinical studies that test new medical devices, diet and lifestyle changes, new procedures and even methods for prevention.

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Pharmaceutical Technology

APRIL 17, 2023

QPS is preparing the pre-investigational new drug applications to be submitted to the US Food and Drug Administration (FDA) and the EU’s European Medicines Agency (EMA) for the CannQuit and ReneCann products. In 2022, the company acquired CannQuit and ReneCann products as part of the acquisition of APIRx Pharmaceuticals.

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XTalks

MAY 28, 2024

VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research. Clay is optimistic about the trajectory of DHTs in clinical trials.

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Drug Discovery World

JULY 5, 2023

Global Cancer Segment Market Manager at Agilent Technologies, recently sat down with DDW Editor Reece Armstrong to tell us about the developments in the ‘golden age’ of cancer research. RA: What is the current state of the cancer research industry? RA: How is Agilent supporting cancer research? Mark Garner, PhD.,

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Velocity Clinical Research

AUGUST 18, 2023

Even as a teen in Egypt, Amira Nada was drawn to the idea of clinical research and how it could help people live healthier, richer lives. They weren’t getting the relief they needed, and I wanted to help change that,” Amira adds. She decided to focus on patient recruitment to promote diversity in clinical trial populations.

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pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

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pharmaphorum

APRIL 26, 2022

In a new whitepaper, Achieving diversity, equity and inclusion in clinical trials , an expert in patient recruitment with a track record of over 16 years Clariness provides a framework to help the clinical trial research industry develop a nuanced and targeted approach to understanding who these patients are and how to make sure they’re included.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Its investigational medicinal products comprise R-107, R-131 and R-147. Douglas provides products in various therapeutic areas which include psoriasis, eczema, dermatitis, chicken pox, constipation, laxative, neonatal, hormone regulation, dermatology, cardiovascular and measles, among others.

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Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

Its investigational medicinal products comprise R-107, R-131 and R-147. Douglas provides products in various therapeutic areas which include psoriasis, eczema, dermatitis, chicken pox, constipation, laxative, neonatal, hormone regulation, dermatology, cardiovascular and measles, among others.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.

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WCG Clinical

SEPTEMBER 26, 2023

Listen and Subscribe: Apple PodCASTs Spotify Google PoDCASTS About this episode: Join WCG Talks Trials podcast host Kelly Fitzgerald, PhD, in a riveting dialogue with guest expert Currien MacDonald, MD, as they unravel the nuances of “Psychedelics in Research: Ethical and Medical Perspectives.”

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ACRP blog

MAY 18, 2023

Jing Wang , MD, PhD, discusses his experiences as a Chinese American whose research centers on the regulation of pain. A faculty member at NYU School of Medicine, Wang is the Valentino D.B. Wang’s research interests center on the role of brain circuits in the regulation of acute and chronic pain. “I

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XTalks

MAY 7, 2024

XTALKS CLINICAL EDGE: Issue 2 — Special Focus on Rare Disease Clinical Research Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. Today, a small percentage of patients are actively engaged.

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XTalks

JANUARY 17, 2024

In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology. It’s very positive and it’s going to help move forward the pathway for new drugs.”

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pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials. You can read part one of this article here.

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Pharmaceutical Technology

MAY 3, 2023

An anti-CD19 and CD20 bi-specific (CAR-T) therapy, C-CAR039 received regenerative medicine advanced therapy and fast-track designations from the US Food and Drug Administration to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

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ACRP blog

AUGUST 23, 2023

The ICH represents a collaboration of FDA, the European Medicines Agency (EMA), and Japan’s health regulatory authority designed, in part, to streamline medical research across their regional and multinational activities. and by ICH, do you think is it possible that DCTs will be regulated significantly differently in these settings?

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Regulation Clinical Trials Clinical Trials Trials 98

pharmaphorum

JANUARY 27, 2021

In medical research, trust has traditionally been hard-fought for. Terms like “lab rats” and “guinea pigs” are often used in conversations about clinical trials. The approval and roll out of the COVID-19 vaccines have put the spotlight on clinical trials. I’m not an anti-vaxxer, but….” Increase awareness and understanding.

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