AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 23, 2023

The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]

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Production Marketing Regulation Drugs 188

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

Pharmaceutical Technology

JUNE 20, 2023

SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. In a Phase III clinical trial, SKYCovione showed neutralising antibody responses against the SARS-CoV-2 parental strain.

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Vaccine Vaccination Protein Clinical Trials 363

pharmaphorum

MARCH 2, 2021

Clinical trial software facilitates clinical trials from conception to finish. For example protocol management, CRF design , metadata management, and the collection, analysis, and submission of compliant clinical study data to regulatory authorities. The aim is to get quality clinical products to the market faster.

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Clinical Trials Clinical Trials Trials Compliance 116

BioPharma Reporter

FEBRUARY 28, 2022

The new clinical trials regulation makes it easier to conduct clinical trials in the EU, according to an EU Commission representative.

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Clinical Trials Clinical Trials Trials Regulation 111

pharmaphorum

OCTOBER 1, 2020

Running clinical trials costs a lot of money! Many clinical trials fail. For example, it can be difficult to recruit patients or they may drop out during the trial. The time it takes to get a product to the market is critical for companies. What is meant by automating clinical trials?

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Clinical Trials Clinical Trials Trials Production 111

Worldwide Clinical Trials

OCTOBER 19, 2022

As evidence emerges about their potential for PTSD, depression, cancer-related distress and more, the market for psychedelics could swell from $2 billion in 2020 to $10.75 With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

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Clinical Trials Clinical Trials Trials Production 130

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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Clinical Trials Clinical Trials Trials Regulation 100

Pharmaceutical Technology

APRIL 20, 2023

According to Daniel Tanner, chief commercial officer at Cerba Research, this patient centricity comes with exciting possibilities to improve trials for all stakeholders. Clinical trials were really not optimised from the perspective of the patient, site orthe sponsor; they are increasingly cost ineffective, and they take a lot of time.

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Clinical Trials Clinical Trials Trials Nurses 130

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

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Manufacturing Marketing Pharma Companies Vaccination 195

pharmaphorum

JULY 26, 2021

A lack of racial diversity in clinical trials is a long-standing, well-documented problem that contributes to the stark health inequalities that have been brought into sharp focus by COVID-19. Tackling it, however, has not been easy, thanks in no small part to the reasons being as complex as they are multi-faceted. Pillars of change.

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Clinical Trials Clinical Trials Trials Production 116

Pharmaceutical Technology

NOVEMBER 28, 2022

Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD). A key natural regulator, NRF2 controls antioxidant genes’ expression.

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Development Gene Expression Licensing Licensing 264

Pharma Marketing Network

NOVEMBER 23, 2024

Just as a chef relies on quality ingredients for the perfect dish, marketers depend on cutting-edge research to craft campaigns that resonate with their audience. The Connection Between Pharma Research and Marketing Effective marketing starts with understanding your audience.

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Marketing Research Big Data Medicine 52

BioPharma Reporter

FEBRUARY 9, 2021

Health officials in Azerbaijan have granted approval for a clinical trial to take place in that country combining Russiaâs Sputnik V vaccine with the Oxford-AstraZeneca COVID-19 shot in adults 18 years and older.

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Clinical Trials Clinical Trials Vaccine Vaccination 145

pharmaphorum

APRIL 26, 2022

Making sure clinical trials are diverse and representative of the populations they’re studying isn’t just the right thing to do to promote inclusivity and equity; it’s also just good science/clinical scientific practice. Potential barriers that exclude communities from clinical research.

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Clinical Trials Clinical Trials Trials Clinical Research 98

BioPharma Reporter

MARCH 14, 2022

Pfizer Inc says it will maintain its supply of medicines to Russia but it will not initiate new clinical trials in the country, while Bayer is suspending investment projects and new-business development in that market.

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Clinical Trials Clinical Trials Trials Business Development 105

Cloudbyz

AUGUST 30, 2024

Clinical trials are the backbone of medical advancements, but their complexity and the regulatory environment pose significant challenges to researchers, sponsors, and clinical trial managers. Managing these trials efficiently while ensuring compliance with stringent regulatory standards is paramount to their success.

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Compliance Clinical Trials Clinical Trials Trials 93

pharmaphorum

DECEMBER 23, 2021

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The draft is open for comment until 22 March.

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Clinical Trials Clinical Trials Trials Regulation 118

ACRP blog

MARCH 23, 2023

Generating evidence by integrating research into patient care Clinical trials are increasingly using longitudinal evidence generation, where repeated measurements are taken over time from the same set of patients. This is leading to changes in expectations of how research sites carry out trials.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Pharmaceutical Technology

NOVEMBER 21, 2022

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 A lower number of clinical trials and regulatory filings were other important influences behind the decision. in 2022 to JPY9.498 trillion ($68.08

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Marketing Sales Manufacturing Drugs 173

Cloudbyz

NOVEMBER 13, 2023

In the ever-evolving landscape of healthcare and medical technology, the importance of conducting efficient and well-managed clinical trials cannot be overstated. Clinical trials generate vast amounts of data, ranging from patient records and laboratory results to adverse events and regulatory submissions.

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Clinical Trials Clinical Trials Trials Compliance 104

Cloudbyz

JUNE 13, 2023

Introduction: Clinical trials are essential for evaluating the safety and efficacy of new medical treatments, therapies, and interventions. Developing an accurate and comprehensive budget is crucial for successful trial planning and execution. Site Selection: Careful site selection is critical for optimizing trial costs.

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Clinical Trials Clinical Trials Trials Marketing 93

pharmaphorum

AUGUST 3, 2022

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted.

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Clinical Trials Clinical Trials Trials Clinical Research 124

World of DTC Marketing

FEBRUARY 7, 2022

According to Endpoint News” We’ve seen Biogen’s CSO exit under pressure in recent weeks, and senior marketing execs leave in an exodus as the company recoiled from a fierce backlash against the FDA’s ultra controversial approval of Aduhelm for Alzheimer’s. Finally, they need to withdraw Aduhelm from the market.

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Pharma Companies Marketing Sales Clinical Trials 253

Cloudbyz

MAY 27, 2024

Although participation in clinical trials is essential to medical progress, a little-known fact is that they are not sufficiently diverse. Ultimately addressing these financial barriers is crucial for the optimal participation of all individuals in clinical trials. percent Native American.

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Clinical Trials Clinical Trials Trials Compliance 95

Cloudbyz

OCTOBER 19, 2023

The pharmaceutical industry plays a critical role in improving healthcare by developing and bringing new medicines to market. Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount.

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Clinical Trials Clinical Trials Trials Compliance 104

pharmaphorum

DECEMBER 6, 2022

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. While many pieces of the drug development process have digitised to keep pace with the speed of technological advancements, clinical trials continue to lag amidst pharma’s digital transformation.

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Clinical Trials Clinical Trials Trials Marketing 98

Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

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Clinical Trials Clinical Trials Trials Compliance 103

Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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FDA Approval Cardiology Clinical Trials Clinical Trials 246

Outsourcing Pharma

JULY 24, 2023

Greenphire, provider of clinical trial financial solutions, has released its global 2023 State of Clinical Trial Patient Convenience Market Trends survey.

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Clinical Trials Clinical Trials Trials Marketing 88

Outsourcing Pharma

JUNE 13, 2024

To guide sponsors, investigators, CROs, and other parties in clinical research, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 97

ACRP blog

FEBRUARY 15, 2023

As we mark Black History Month, what are your thoughts on overall efforts to improve diversity within the clinical trials ecosystem? I am encouraged by how focused we are as an industry on addressing the serious underrepresentation of diverse populations in clinical trials. Although I was quite happy that the U.S.

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Clinical Trials Clinical Trials Trials Clinical Research 102

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

BioPharma Reporter

APRIL 28, 2021

As COVID-19 response initiatives and vaccine rollouts begin to bring the pandemic under control, we consider what changes to clinical trials will be made permanent.

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Clinical Trials Clinical Trials Trials Vaccine 110

pharmaphorum

JUNE 11, 2021

Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats. However, data-intensive, decentralised clinical trials also present a major risk to healthcare participants through cybercrime and data privacy vulnerability.

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Clinical Trials Clinical Trials Trials Compliance 111

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

Pharmaceutical Technology

MAY 4, 2023

Idorsia has received marketing authorisation from Health Canada for Quviviq (daridorexant) to manage insomnia in adult patients. The regulator recommended one Quviviq 50mg oral tablet each night, taken 30 minutes before going to bed with a minimum of seven hours remaining before planned awakening.

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Marketing Clinical Trials Clinical Trials Regulation 130