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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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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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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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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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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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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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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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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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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Clinical Trials Clinical Trials Trials Life Science 101

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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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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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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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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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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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

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

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

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 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

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 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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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. Integrating DHTs Across Drug Development Phases Dr.

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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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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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Clinical Trials Clinical Trials Trials Life Science 52

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”. Tabakin agrees. “In

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Cloudbyz

JANUARY 27, 2021

Clinical Trial Management (CTMS). Clinical Trial Budget Management. Electronic Trial Master File (eTMF). ☰ Setting up a virtual clinical trial: Things to consider. The pharmaceutical industry has been forced to find new and innovative approaches to try clinical trials. eCOA / ePRO.

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Clinical Trials Clinical Trials Trials Packaging 98

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. About the author.

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Clinical Trials Clinical Trials Trials Compliance 109

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.

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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.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. percent show less reliability). Optimal methods for bioinformatic analysis are still needed.

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Drug Discovery World

SEPTEMBER 12, 2022

We are hopefully nearing the tail-end of a pandemic that made the whole world become participants in that deep learning experience of what clinical development is. I think never before did we have families sit on the couch and talk about Phase I, II and III clinical trials. Never before was the whole world a potential patient.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

Rivus Pharmaceuticals has raised $132m in a Series B funding round to clinically advance its lead candidate, HU6, for the treatment of obesity and cardio-metabolic disorders. RA Capital Management led the financing round, which also saw participation from Bain Capital Life Sciences and BB Biotech.

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Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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