PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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PPD

JUNE 7, 2023

By partnering with a contract research organization (CRO) that understands the challenges of liver disease clinical trials — and the complexities of working with pediatric populations — you can drive your treatment forward. Partnership with an experienced CRO is essential to your trial’s success. Hispanic: 11.8%

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PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Clinical Trials Trials Clinical Research Disease 98

Conversations in Drug Development Trends

APRIL 3, 2024

Are you aware of the challenges you must address for a successful radiopharmaceutical trial? Enhancing Patient Participation in Radiopharmaceutical Trials Patient recruitment is a critical yet challenging part of radiopharmaceutical trials.

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Trials Clinical Trials Compliance Treatment 81

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Trials Clinical Trials Regulations FDA 80

On Medicine

NOVEMBER 27, 2023

On the International Day of Persons with Disabilities , it is important to make sure that we think about ALL people with disabilities. The trial We are recruiting 66 educational settings and will involve 330 children and young people and their families. We will conduct the study at educational settings throughout the country.

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Antidote

JUNE 22, 2023

Creating clinical trial marketing materials is a delicate balance — it's important to craft outreach that connects with patients and care partners, but it’s also important to adhere to the guidelines set out by the Food and Drug Administration (FDA) to receive the approval of the Internal Review Board (IRB).

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Clinical Trials Trials International FDA 59

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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Trials Clinical Trials International Regulations 59

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy. local standards of care).

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Clinical Trials Trials International Clinical Research 97

On Medicine

MAY 17, 2023

Yet, what about those who took part in the trial? In recent years there has been an increasing call to let trial participants know the results of trials in which they have taken part. Back in 1995 only one person in every 27 was on a trial in cancer. The post Clinical Trials Day 2023: what about the trial participant?

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Vial

JUNE 12, 2024

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? In a study on cancer clinical trials, Pe et al. In a study on cancer clinical trials, Pe et al.

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Clinical Trials Trials FDA Clinical Research 52

Alta Sciences

AUGUST 21, 2024

Internships at Altasciences: Q&A With Our Summer Interns nbartlett Thu, 08/22/2024 - 04:44 Internships at Altasciences are more than just a stepping stone—they’re a gateway to real-world-experience and professional growth, giving the next generation opportunities to help shape progress in the drug development industry. The work environment.

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International Laboratories Science Molecular Biology 40

Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Representation, Underrepresentation & Diversity in Clinical Trials Studies indicate a need to increase patient accessibility to clinical trials.

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Clinical Trials Trials Clinical Research Research 52

Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.

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Clinical Trials Trials Clinical Development Clinical Research 52

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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Clinical Trials Trials Compliance Laboratories 52

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. As clinical trial design becomes more dynamic and adaptive, studies require more complex statistics and more specialized biostatisticians to ensure study data are relevant and scientifically valid.

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Trials Clinical Trials FDA Approval Therapies 52

H1 Blog

JULY 19, 2023

Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics , regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.

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Clinical Trials Trials FDA Treatment 52

ASPET

JUNE 22, 2023

Clinical trials assessing the impact of Radiotherapy (RT) in combination with inhibitors of the DNA Damage Response Pathway (DDRi) and/or immune checkpoint blockade are currently ongoing. Nonlinear mixed effects modelling was performed followed by internal validation with Visual Predictive Checks (VPC).

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DNA Clinical Trials International Trials 100

SCIENMAG: Medicine & Health

JUNE 15, 2023

Results from an international clinical trial, published June 15 […] Credit: Vanderbilt University Medical Center A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options.

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Treatment Clinical Trials Therapies International 83

H1 Blog

MARCH 23, 2023

Clinical trial performance knowledge on physicians and research sites is one of these elements. H1 is pioneering in the area of clinical trial performance data integration and use and regularly advises customers in 3 key areas. What Is Performance Data and How Do You Benchmark It? How Can Performance Data Make a Difference?

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Clinical Trials Trials Research International 52

PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In addition, the constant evolution of EMA and Clinical Trials Coordination Group (CTCG) guidelines requires constant attention.

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Clinical Trials Trials Regulations Pharmaceutical Companies 52

Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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Clinical Trials Trials Laboratories Research Laboratories 52

Advarra

JUNE 16, 2022

Sponsors: The trial sponsor is primarily responsible for many study startup activities including but not limited to : . Engaging a CRO to assist in the execution of the trial . Collecting, storing, and submitting the data and documents associated with the trial . Conducting clinical trial visits and procedures .

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Clinical Trials Trials Research International 52

Advarra

MAY 9, 2023

In today’s world of research, using a clinical trial management system (CTMS) can significantly streamline operations, and make for a more efficient research study. A comprehensive system like Advarra’s OnCore CTMS centralizes communication, proactively facilitating collaboration among internal teams to break down silos.

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Clinical Trials Trials Research International 52

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions. WHY IS PAIN RESEARCH SO IMPORTANT?

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Clinical Trials Treatment Trials Drug Development 52

The Pharma Data

AUGUST 14, 2020

Many countries have criticised Russia pursuit for a COVID-19 cure, which has skipped Phase 3 trials before giving the vaccine regulatory approval. According to the MailOnline , Chuchalin said to them: “Have you passed all the necessary paths approved by the Russian Federation legislation and the international scientific community?

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Vaccine Doctors Clinical Trials Trials 87

Conversations in Drug Development Trends

APRIL 4, 2024

To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016. The post Demystifying the ICH M10 Bioanalytical Method Validation Guidelines appeared first on Worldwide Clinical Trials.

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Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Clinical Trials Trials Compliance FDA 40

thought leadership

JULY 20, 2023

Good clinical practice ( GCP ) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human subjects. This article has been updated since it's original publication date.

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Clinical Trials Trials Clinical Research International 40

PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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Clinical Development Clinical Trials Therapies Trials 98

LifeSciVC

JANUARY 16, 2024

The expectation that Pharma will continue buy-ups here is helping to fuel conviction for another strong year ahead for M&A, especially for those acquirers who will rely on inorganic acquisition to build in areas under-represented by internal R&D (e.g., Additional trials (e.g.,

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Small Molecule Trials Therapies Disease 138

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. It’s important to understand the differences between FSO and FSP solution models for outsourcing clinical trials and how best to combine approaches for optimization. Overseen by an insourced project manager.

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Drug Development Clinical Trials Drugs Clinical Research 98

Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,

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Clinical Trials Trials Science FDA 40

PPD

JULY 16, 2024

To institutionalize the systems and processes related to these new reporting requirements, our PPD FSP Pharmacovigilance solutions team first had to undertake extensive research into the adoption of International Conference on Harmonisation (ICH) guidelines in China.

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Compliance Regulations Production Trials 98

PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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Drug Development Clinical Trials Compliance Trials 52

PPD

OCTOBER 31, 2024

From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.

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Drug Development Clinical Trials Trials Drugs 52

Drug Target Review

JULY 6, 2023

1 Ethical concerns surrounding the use of animal studies is increasing, especially considering 90 percent of drug candidates fail in clinical trials. 2 Therefore, the scientific community is researching and developing efficient ways to test compounds without the use of animals, to avoid unsuccessful outcomes in clinical trials.

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