XTalks

MAY 21, 2024

Yesterday, on International Clinical Trials Day 2024, the global healthcare community came together to commemorate the significant advancements in clinical research and the vital role clinical trials play in improving patient care and outcomes.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

Clinical trials were thrown into turmoil on the morning of 24 February 2022, along with every aspect of life in Ukraine. In July, approximately a third of companies had paused a trial in the country. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

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pharmaphorum

SEPTEMBER 2, 2020

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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STAT News

MARCH 22, 2023

Medicines and Healthcare products Regulatory Agency announced sweeping changes to regulations governing clinical trials , Pharmaphorum explains. Have a grand day and drop us a line if you hear something saucy … The U.K.

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pharmaphorum

MAY 26, 2022

Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening. While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go.

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Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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Advarra

JANUARY 13, 2023

New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g., Endpoint adjudication committees (EACs), also called clinical event committees (CECs), receive potentially identifiable research data from all over the world.

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ACRP blog

MARCH 12, 2024

Global Disruptions, Health Equity, and Data Sharing International clinical trials are essential to evaluating the safety and efficacy of new treatments, but their success can be hampered by a variety of challenges. From legal considerations to data privacy regulations, the challenges facing these teams can be daunting.

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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.

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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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XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. Evolution in Oncology Clinical Trial Design Recent discussions at ESMO highlight a shift in how clinical trials are designed and conducted.

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Cloudbyz

DECEMBER 15, 2023

Veterinary clinical trials and human clinical trials share some similarities, but there are key differences owing to the distinct nature of the subjects involved—animals versus humans. The aim is to improve the well-being of animals, enhance veterinary medicine, and contribute to public health (e.g.,

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Drug Discovery World

FEBRUARY 1, 2023

Michael Sassano , CEO at SOMAÍ Pharmaceuticals looks at what’s needed throughout Europe to help increase access to medicinal cannabis and the current state of pharmaceutical research in this area. The use of medicinal cannabis across much of the world is still in its infancy.

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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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Worldwide Clinical Trials

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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Pharmaceutical Technology

MARCH 20, 2023

Africa has considerable advantages and opportunities for trialling investigational medicinal products that, if pharma companies can correctly harness, will turn the continent into a superpower for clinical trials. Clinical trials data for Africa Globally, research has found that 62.2% being African American, 3.4%

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The Pharma Data

MAY 7, 2021

World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.”. .

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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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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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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.

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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.

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Pharmaceutical Technology

JUNE 19, 2023

Meeting strict client timelines is essential for clinical trials, but complications can arise when dealing with investigational medicinal products (IMPs) across several countries. Regulations can be challenging, with ever-changing rules. And accurate labelling and translation are critical for this sector.

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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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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.

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Pharma Business Blog

NOVEMBER 24, 2022

This news will impact all the companies that are doing clinical trials in Europe. EU pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. This requirement is based on EU pharmaceutical legislation, as outlined in the European Commission Communication.

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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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Rethinking Clinical Trials

APRIL 24, 2024

Matthew Semler In this Friday's PCT Grand Rounds, Lauren Milner of the US Food and Drug Administration (FDA) and Jonathan Casey and Matthew Semler of Vanderbilt University will present "Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – FDA Regulation Development and Research Landscape."

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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.

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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.

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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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Worldwide Clinical Trials

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. An illustrative example of harmonization between agencies exists via the European Medicines Agency (EMA) and U.S.

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Drug Discovery World

SEPTEMBER 4, 2023

A new whitepaper has introduced the concept of ‘cross-over’ options in cancer clinical trials, as a way to make trials more patient-centric in design. It also encourages sponsors, investigators and regulators to advance patient-centric trial designs.

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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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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.)

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Cloudbyz

JUNE 16, 2023

Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Effectively managing and storing such large datasets presents logistical challenges.

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Pharma Business Blog

MARCH 15, 2023

Dears Please find hereinafter the latest news related to Clinical Trials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

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Drug Discovery World

FEBRUARY 7, 2024

The sNDA is based on results from the Phase III EV-302 clinical trial. The study found the combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy.

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