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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Imperical Blog

JANUARY 9, 2024

Diversity in clinical trials is becoming mandatory, which can make drugs and devices more widely beneficial. New FDA regulations are coming; read on for our understanding of what to expect.

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XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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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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Cloudbyz

AUGUST 26, 2024

Implementing a Clinical Trial Management System (CTMS) is a critical step for any life sciences organization aiming to enhance the efficiency, compliance, and oversight of their clinical trials. Data Security Protocols: Establish robust data security protocols to protect sensitive clinical trial data.

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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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XTalks

MARCH 25, 2021

Xtalks is proud to announce the launch of the Xtalks Life Science podcast. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Fresh Conversations About Life Science Topics. Sarah is passionate about science communication and journalistic integrity.

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Cloudbyz

AUGUST 13, 2024

In the rapidly evolving landscape of life sciences, the need for robust, efficient, and compliant pharmacovigilance (PV) solutions has never been greater. In this blog, we’ll explore how these solutions are transforming pharmacovigilance and why they are becoming the go-to choice for forward-thinking life sciences companies.

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XTalks

MAY 30, 2024

At the forefront of transforming clinical studies is the Clinical Trials Transformation Initiative (CTTI) , which has been instrumental in shaping the future of clinical trials to be more efficient, inclusive and patient-centered.

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Cloudbyz

MARCH 1, 2023

Clinical trials are a critical component of drug development in the life sciences industry. Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments. Following are the benefits of digitizing clinical trials budgets and payments.

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Clinical Trials Clinical Trials Trials Compliance 98

Pharmaceutical Technology

JULY 8, 2022

VDRs may be used for asset sales, audit tenders, bankruptcies, due diligence processes, mergers & acquisitions, public and private debt and equity capital raising, clinical trials, and organisational restructuring. Regulations protecting everything are made more robust. Privacy and security. Security is made more secure.

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Pharma Business Blog

JULY 22, 2020

The year 2020 has seen a lot of development in the way we do business such as new regulations and smarter solutions to solve old and new challenges. Find out more about each of PwC’s Pharma & Life Sciences Hot Topics 2020 in the attached PDF below. PwC’s Pharma & Life Sciences Hot Topics Download.

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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

MARCH 30, 2023

In today’s digital age, life sciences organizations are collecting, storing, and processing vast amounts of sensitive data, including personally identifiable information (PII) and protected health information (PHI). As such, it’s becoming increasingly challenging for organizations to manage and secure this data.

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Cloudbyz

MARCH 17, 2023

Good Clinical Practice (GCP) is an international standard that outlines ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving human subjects. Deviations from the protocol can impact the study’s integrity and raise ethical concerns.

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XTalks

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Regulatory Considerations.

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XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

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ACRP blog

JULY 6, 2022

“The time for pontification is over when it comes to improving diversity in the clinical trial population,” says Reginald Swift, PhD, founder and CEO of Rubix Life Sciences. Industry has been too traditional in its thinking about how to truly promote patient diversity in the clinical trial population, he says. “We

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pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Safety will create a single source of truth for content management.

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Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Let’s explore.

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XTalks

JULY 6, 2022

The adoption of decentralized clinical trial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Rachel Colite, VP Decentralized Clinical Trials, Cogstate.

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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. Dr. Sandra Ragaz , Partner Leader Pharma & Life Science VAT Switzerland +41 79 792 72 98 sandra.ragaz@pwc.ch.

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XTalks

AUGUST 9, 2024

Pharmaceutical, life sciences and healthcare organizations have long had the desire to make their research programs more accessible and patient-centric. One of the key elements to the successful execution of a decentralized clinical trial (DCT) is providing patients access to in-home specimen collections and assessments.

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XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Can you tell us a bit about the work you are doing at NORD and how it impacts clinical trials for rare diseases?

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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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Cloudbyz

MARCH 28, 2023

This solution is designed to meet the unique needs of clinical research organizations (CROs) and pharmaceutical companies, offering a range of features to help them streamline their operations, manage clinical trials, and ensure compliance with regulatory requirements.

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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 The same principle applies to regulation,” she went on.

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XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Clinical Data Pipeline for Data Review and Analyses.

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pharmaphorum

AUGUST 17, 2022

The latest life science competitiveness indicators (LSCIs) were published by the Office of Life Sciences (OLS) in July 2022. The life sciences ecosystem. Interest in indicators. If we aren’t already, we’re all likely to be patients one day, or caregivers of one at some point in the future.

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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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pharmaphorum

OCTOBER 1, 2020

Many companies in the life sciences industry are slow to adopt new technologies. 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. What is meant by automating clinical trials?

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XTalks

JANUARY 17, 2024

To gain insights into how clinical trials for lupus can be enhanced with RWD sources, we spoke with Frederico Calado, VP of Global Real-World Solutions at Alira Health , and Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center.

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pharmaphorum

AUGUST 16, 2021

Over the past two years, the pharma industry’s demand for automated research solutions has increased significantly and, particularly when it comes to clinical trial design, the need has never been greater. COVID-19 has demonstrated that trials can be run much more efficiently, to everyone’s benefit. Compliance is key.

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Clinical Trials Clinical Trials Trials Compliance 98

XTalks

APRIL 13, 2022

Pediatric rare disease clinical trials are vital to determining the safety and efficacy of medications for children living with a rare disease. Therefore, pediatric rare disease clinical trials are vital to determining the safety and efficacy of medications for children living with a rare disease.

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pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions. There’s also that risk of a perceived coercion or influence.

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XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Several oncology products now have “blockbuster” status where sales exceed $1 billion annually. Herceptin (Trastuzumab) and Mabthera (Rituximab).

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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. BRIDGE represents the magnitude of impact we aim to make in life sciences in our next decade.” The post Financing pushes value of clinical trial tech firm Reify to $4.8bn appeared first on.

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