Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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Clinical Research Research Trials Clinical Trials 98

Pharma Mirror

MAY 7, 2021

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion Market Demand appeared first on Pharma Mirror Magazine.

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Clinical Trials Clinical Trials Gene Marketing 130

BioPharma Reporter

JANUARY 17, 2023

In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.

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Clinical Research Research Trials Regulation 123

Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, 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.

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Clinical Research Research Compliance Clinical Trials 98

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. This post originally appeared on Signant Health.

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Clinical Research Research Clinical Trials Clinical Trials 97

Find Me Cure

SEPTEMBER 2, 2020

As part of our patient advocacy efforts, at FindMeCure we are dedicated to creating a bridge between patients and the world of clinical research. This includes spreading clinical trial awareness, connecting patients to the trials they are interested in but also speaking up about the issues in the clinical research industry. .

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Clinical Research Research Clinical Trials Clinical Trials 97

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 12, 2022

The Subject Expert Committee (SEC) for Reproductive and Urology, which advices the nation’s drug regulator on clinical studies and approvals, has recommended approval for the State-run HLL Lifecare Ltd to manufacture and market graphene condom, the next generation thinner; and stronger condom that is expected to improve the acceptability of the (..)

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Regulation Manufacturing Production Marketing 189

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 2, 2023

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]

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Trials Clinical Trials Clinical Trials Drugs 188

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 14, 2022

The medical devices industry in the country has sought the Centre to define online and offline mode of sale, provide more clarity on the regulations that are binding the online sales and suggested inclusion of online medical devices players under the Uniform Code for Medical Devices Marketing Practices (UCMDMP).

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Sales Regulation Marketing Drugs 182

pharmaphorum

AUGUST 5, 2020

Bringing clinical trials to patients – rather than the reverse – could be the key to improving recruitment into studies and making them faster, cheaper and more likely to succeed, according to one clinical research organisation (CRO). billion in the past 10 years, says ICON.

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Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Approximately only 20 % of the drugs that enter phase I are approved for marketing. 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).

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Marketing Research Trials Clinical Trials 97

Pharmaceutical Technology

JULY 18, 2022

Novartis is developing icenticaftor (QBW251), a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator. As such, the opportunity remains for developers to continue to conduct clinical research in this area, with the hopes of more MOAs to enter the space in the future.

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Outsourcing Pharma

JUNE 14, 2023

In a bid to address the high demand for clinical research talent, Advanced Clinical is hosting an innovation theater at DIA Global in Bostonâs Convention and Exhibition Center.

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Clinical Research Research Regulation Marketing 88

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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Regulation Clinical Trials Clinical Trials Medicine 162

Outsourcing Pharma

MARCH 29, 2022

A leader from the healthcare technology company discusses the conflictâs impact on the region and beyond and the need to better guard against interruptions.

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Clinical Research Research Regulation Marketing 101

Outsourcing Pharma

NOVEMBER 6, 2023

Medidata has recommitted to Catalyst Clinical Research to support its worldwide oncology brand, Catalyst Oncology.

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Outsourcing Pharma

NOVEMBER 6, 2023

Medidata has recommitted to Catalyst Clinical Research to support its worldwide oncology brand, Catalyst Oncology.

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Clinical Research Research Branding Regulation 63

XTalks

FEBRUARY 23, 2024

Chicago-based Linden Capital Partners and Canada’s Ontario Teachers’ Pension Plan are partnering with Elligo Health Research to launch a platform focused on advancing clinical research. This collaboration aims to leverage Elligo’s expertise in healthcare research, utilizing their innovative approaches to clinical trials.

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Clinical Research Research Clinical Trials Clinical Trials 59

Outsourcing Pharma

OCTOBER 26, 2022

The ABPI releases a report that shows the number of clinical trials taking place in the UK fell by a large amount between the years 2017 and 2021.

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Clinical Research Clinical Trials Clinical Trials Research 95

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Global Regulatory Compliance: Ensures compliance with 21 CFR Part 11 and other global regulations, reducing compliance risks.

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Life Science Clinical Trials Clinical Trials Compliance 52

ACRP blog

SEPTEMBER 20, 2023

Frankly, that just wasn’t the case—the effort put into the original content wasn’t communicated effectively, and the individuals in those target markets lost out as a result. This is where I learned first-hand about some of the many challenges clinical researchers, especially at the site level, faced with patient recruitment and retention.

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Clinical Research Research Life Science Clinical Trials 59

Outsourcing Pharma

NOVEMBER 6, 2023

Medidata has recommitted to Catalyst Clinical Research to support its worldwide oncology brand, Catalyst Oncology.

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Clinical Research Research Branding Regulation 52

Roots Analysis

MARCH 24, 2022

However, research related to metabolites is essential to increase the understanding of molecular level interactions, functions, modifications and regulations in cells, therefore, the field of metabolomics plays a vital role in biomarker discovery for early disease diagnosis and prognosis as well as for drug discovery and development processes.

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VirTrial

OCTOBER 14, 2020

The training and certification initiative aims to provide sustainable study and patient opportunities for investigator sites, while demonstrating telemedicine technology competencies in the eyes of international regulators. “VirTrial was created with sites in mind from the start,” says Kim Kundert, Executive Vice President.

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Compliance Clinical Research Clinical Trials Clinical Trials 98

Outsourcing Pharma

NOVEMBER 17, 2022

Icon is looking to its Accellacare global clinical research network to mitigate the effect of site staffing issues on the speed at which trials are executed and revenues are realized.

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Clinical Research Research Trials Regulation 52

pharmaphorum

JUNE 8, 2021

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”.

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Marketing Drugs Development Regulation 105

XTalks

DECEMBER 10, 2024

These markers are used to understand disease progression and play a critical role in meeting regulatory standards and securing marketing authorization. The Future of MASH Clinical Trials Liver biopsies remain a critical tool in MASH clinical research. Zabbatino.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Pharma Marketing Network

NOVEMBER 7, 2024

With a competitive landscape and ever-evolving regulations, having effective pharmaceutical marketing strategies is crucial for pharma companies looking to stand out. Pharma marketers must think creatively and strategically. Educational Content Is King Healthcare professionals value well-researched, credible information.

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Marketing Compliance Branding Regulation 52

WCG Clinical

AUGUST 22, 2023

PRINCETON, NJ, August 22, 2023: WCG, the global leader in providing solutions that measurably improve the quality, efficiency, and safety of clinical research, today announces the WCG MAGI Clinical Research Conference, an educational mainstay for clinical trial professionals for more than 15 years, is going virtual for its fall 2023 event.

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Clinical Research Research Compliance Clinical Trials 40

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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Clinical Trials Clinical Trials Trials Clinical Research 111

Cloudbyz

MARCH 15, 2023

March 15, 2023 /PRNewswire/ — Cloudbyz, a leading provider of unified clinical trial management solutions, today announced the launch of its innovative Electronic Data Capture (EDC) product, Cloudbyz EDC 2.0. Designed to revolutionize the clinical research landscape, Cloudbyz EDC 2.0 NAPERVILLE, Ill.

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Clinical Research Research Clinical Trials Clinical Trials 52

Outsourcing Pharma

MARCH 29, 2021

According to a Veeva Systems survey, contract research organizations are working to ensure clinical trials keep going during the COVID-19 era and beyond.

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Clinical Research Research Clinical Trials Clinical Trials 64

pharmaphorum

APRIL 26, 2022

Potential barriers that exclude communities from clinical research. With new regulations, including the 2021 guidance’s by the European Medicines Agency and US FDA emphasising the need for greater representation, addressing this issue is now even more vital for clinical researchers.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

MARCH 25, 2022

As few as 2% have peer-reviewed research to back up their claims. ”. These analyses focused exclusively on wellness and smoking cessation apps, bypassing a category of digital therapeutics regulated by the FDA that make scientifically validated claims using sound research. Consistent Standards Matter.

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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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Worldwide Clinical Trials

APRIL 3, 2024

Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity. By emphasizing transparency and patient autonomy, trials can maintain ethical standards while fostering trust and participation.

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Trials Clinical Trials Clinical Trials Compliance 204

Cloudbyz

JUNE 13, 2023

Engage with stakeholders, including clinical research coordinators, investigators, finance departments, and sponsors, to gather input and ensure accuracy. Dedicated clinical trial management systems can help manage budgets effectively, track expenses, generate reports, and improve overall financial efficiency. Best Practices 3.1

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Clinical Trials Clinical Trials Trials Marketing 93