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.”

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

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.

Clinical Trials 122

Clinical Trials Clinical Trials Trials Regulation 122

Pharmaceutical Technology

APRIL 20, 2023

The face of clinical research is evolving. Rather than bringing patients to sites, study teams are now exploring ways they can bring the trial to patients using a varying combination of direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. Everybody got used to doing things remotely.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Nurses 130

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. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

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.

Clinical Trials 89

Clinical Trials Clinical Trials Trials Regulation 89

pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As ” Prerequisites for global competitiveness.

Regulation 85

Regulation Medicine Life Science Development 85

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Compliance Research Regulation 52

pharmaphorum

DECEMBER 19, 2022

The EU has published new recommendations aiming to encourage the use of decentralised clinical trials (DCTs) – and to make sure patients who participate in them have their sights an wellbeing safeguarded. The also includes an overview of national provisions for specific DCT elements to be used in clinical trials.

Regulation 72

Regulation Trials Clinical Trials Clinical Trials 72

pharmaphorum

NOVEMBER 15, 2022

A renaissance in vaccines research is just one example of something good to come out of the pandemic. For the clinical trials industry, the pandemic forced new ways of working and fresh ways of thinking about clinical research and how to conduct it remotely. Technology driving patient-centric practices.

Clinical Research 97

Clinical Research Research Clinical Trials Clinical Trials 97

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.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Drug Discovery World

NOVEMBER 8, 2023

Deepika Khedekar , Associate Centralized Clinical Lead at IQVIA, explains how artificial intelligence could make clinical trials more accurate, accessible and standardised. Tapping into the capabilities of AI One reason AI may accelerate clinical trials is its ability to rapidly process and analyse vast amounts of data.

Clinical Trials 72

Clinical Trials Clinical Trials Trials Drugs 72

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. Clinical Research is sometimes also referred to as Medical Affairs or Clinical Affairs.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

VirTrial

AUGUST 21, 2021

In clinical trials, the application of telemedicine technology is still evolving. Clinical trials have far more considerations and challenges beyond the basic patient-clinician interaction. Training and support by clinical science and medicine experts familiar with clinical trial operations.

Clinical Research 97

Clinical Research Research Clinical Trials Clinical Trials 97

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.

Clinical Trials 74

Clinical Trials Clinical Trials Trials Regulation 74

Cloudbyz

MAY 15, 2023

Clinical trials play a critical role in medicine and healthcare, offering valuable insights that inform treatment options, drug development, and patient care. As such, the integrity of data collected during these trials is paramount. Audits can reveal systemic issues and provide opportunities for improvement.

Clinical Trials 82

Clinical Trials Clinical Trials Trials Compliance 82

XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. The COVID-19 pandemic certainly has pushed to the forefront of clinical trials, the digital evolution in clinical research. MRI scan, endoscopy, etc.)

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

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.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Worldwide Clinical Trials

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Check out this webinar on navigating the landscape of oncology clinical trials.

Antibody 162

Antibody Clinical Trials Clinical Trials In-Vitro 162

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.

Medicine 52

Medicine Genetics Clinical Trials Clinical Trials 52

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.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

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.

Clinical Trials 110

Clinical Trials Clinical Trials Trials Clinical Research 110

Cloudbyz

NOVEMBER 30, 2021

As a relatively young industry, it’s no wonder that the clinical trial industry tends to undergo rapid change. Decentralized Clinical Trials. Decentralized Clinical Trials (DCTs) are clinical trials that remove reliance on central research sites for clinical studies.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

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.

Regulation 162

Regulation Clinical Trials Clinical Trials Medicine 162

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+

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

Clinical Research 226

Clinical Research Research Gene Therapy Gene 226

XTalks

MAY 28, 2024

The traditional clinical trials model is facing scrutiny. 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.

Clinical Development 116

Clinical Development Development Clinical Trials Clinical Trials 116

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccination 105

pharmaphorum

JULY 14, 2022

A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical trials submitted in support of new marketing application along with the usual structured analyses from sponsors. It may also help the regulator to define target treatment populations better.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Advarra

NOVEMBER 17, 2022

Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. Usually, when there aren’t data to support enrolling children in clinical trials, the risk threshold requires the prospect of direct clinical benefit. Why This Guidance Now?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Rethinking Clinical Trials

OCTOBER 27, 2022

Duke Clinical Research Institute. Chief Research Technology Strategist. Duke University School of Medicine . ePatient and Security Researcher. Should social media for teenagers be regulated like a digital therapeutic, given how addictive they are and the behavior modification. Eric Perakslis, PhD.

Clinical Research 130

Clinical Research Research Clinical Trials Clinical Trials 130

pharmaphorum

APRIL 22, 2022

billion, with plans to use the new cash to launch a new initiative to make sure clinical trials are inclusive and diverse. The post Financing pushes value of clinical trial tech firm Reify to $4.8bn appeared first on. Image by truthseeker08 from Pixabay .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

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.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Crucial Data Soutions

NOVEMBER 16, 2022

Despite the rise in utilization of decentralized clinical trial (DCT) elements, there are still many misconceptions. While the last few years have allowed many research stakeholders to see firsthand the ability of DCT elements to help reach patients outside the clinic setting, there remain concerns and questions.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 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.

Pharmacy 151

Pharmacy Sales Licensing Licensing 151

XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. Patient input is a crucial component of rare disease clinical trials, as it can provide valuable insights into the patient experience and inform decisions about study design and implementation.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Development 97

Pharmaceutical Technology

APRIL 17, 2023

The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases.

Dermatology 130

Dermatology Clinical Trials Clinical Trials Production 130