ProRelix Research

DECEMBER 28, 2023

Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.

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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

FDA Law Blog: Biosimilars

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. In other words, the inspectional output was inversely proportional to the importance of clinical research.

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Advarra

SEPTEMBER 19, 2024

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

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Quanticate

AUGUST 19, 2024

In recent years the requirement for maintaining a robust audit trail has become crucial for ensuring data integrity, transparency, and compliance with regulatory requirements. An audit trail is a comprehensive log that records all activities, including modifications, additions, and deletions of data, within a clinical trial.

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Regulations Clinical Research Clinical Trials Compliance 52

Advarra

FEBRUARY 13, 2024

Every day, clinical research organizations work to deliver a seamless user experience for their staff, while also providing robust security measurements to protect their data and stay compliant. Having a singular password could also potentially affect trial timelines.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.

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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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Advarra

JUNE 27, 2023

Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. A clinical trial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV.

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

Advarra

OCTOBER 17, 2023

Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. Oftentimes, sites hold off billing for specific visits or procedures related to a trial if they are not 100% sure the item is billable.

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Clinical Research Research Clinical Trials Compliance 52

Quanticate

SEPTEMBER 11, 2024

The Importance of SAS Quality Control in Clinical Trials Quality control (QC) in clinical trials is essential for ensuring the integrity and reliability of data. Leveraging SAS (Statistical Analysis System) for QC processes offers a powerful solution for clinical researchers.

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Clinical Trials Trials Compliance Clinical Research 52

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.

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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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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. The government has also enacted strict trade compliance policies that limit genetic materials, such as patient cells, leaving and entering China.

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Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

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Conversations in Drug Development Trends

JULY 9, 2024

Challenges in GLP-1 Medication Usage Despite the emerging therapeutic benefits of GLP-1 medications, these treatments also face several challenges, including: Patient Compliance Due to Side Effects One considerable challenge of GLP-1 treatments is their administration method, which is typically a daily injection.

Clinical Research 52

Clinical Research Treatment Research Clinical Trials 52

Vial

FEBRUARY 21, 2024

Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products.

Clinical Trials 52

Clinical Trials Trials Compliance Regulations 52

Conversations in Drug Development Trends

APRIL 8, 2024

By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success.

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Clinical Trials Clinical Research Trials Compliance 75

Advarra

AUGUST 21, 2024

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinical trials, the backbone of drug development. However, it is often unengaging, cumbersome, and manual.

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Clinical Trials Trials Compliance Clinical Research 52

Advarra

MARCH 14, 2023

Maintaining regulatory compliance at research sites and institutions is no small feat – documents need to be updated and maintained in a consistent manner to ensure compliance. Advarra’s eRegulatory Management System (eReg) is designed to adapt to and streamline research site regulatory workflows.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. The post Risk Assessment for use of Engineered Genetic Materials in Clinical Research appeared first on Advarra.

Engineering 52

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Conversations in Drug Development Trends

JANUARY 6, 2025

In contrast, an adaptive trial design allows for modifications to an ongoing trial and its analyses under a pre-specified framework, which is outlined in the FDAs Adaptive Designs for Clinical Trials for Drugs and Biologics Guidance for Industry, published in 2019.

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials.

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Clinical Trials Trials Clinical Research Research 52

PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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Clinical Trials Trials Clinical Research Disease 59

Advarra

OCTOBER 4, 2022

Clinical trial site selection can make or break a trial’s success before it even begins. When you consider around 11% of sites 2 fail to even accrue one participant on a given study, cost savings become a major consideration when evaluating which sites to partner with for a trial.

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Clinical Trials Trials Clinical Research Research 52

Conversations in Drug Development Trends

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Clinical Trials Trials Treatment Compliance 52

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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Perficient: Drug Development

SEPTEMBER 25, 2024

Clinical trial data management is critical to pharmaceutical research, yet it remains a significant challenge for many organizations. The industry faces several persistent hurdles: Data fragmentation: Research teams often struggle with siloed information across departments, hindering collaboration and comprehensive analysis.

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PPD

AUGUST 9, 2023

The increased adoption of decentralized clinical trial (DCT) designs has revolutionized how the industry approaches clinical studies. In short, for clinical trial design to truly benefit from the digital revolution, data flow, management and analysis are the next frontiers.

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Clinical Trials Trials Clinical Research Regulations 52

PPD

JUNE 29, 2023

To be competitive, drug developers must run their trials efficiently and within budget and timelines, while still maintaining quality to support authorization. My personal experience drives my passion to enable drug developers in the quest for better treatments with less complicated compliance requirements.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

Advarra

JANUARY 18, 2024

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate with research site teams to activate and execute clinical trials. Continue to monitor training engagement and accuracy throughout the trial.

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Clinical Trials Trials Compliance Clinical Research 52

Vial

MAY 13, 2024

However, progress from molecule to approved drug is hampered by extremely high costs and lengthy clinical trials , and approximately 90% of drugs that reach clinical trials fail. only 5% of molecules in oncology Phase I trials reach the market taking, on average, 7.5 According to Rodríguez-Molinero et al.,

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Clinical Trials Trials Drug Development Production 52

Advarra

OCTOBER 19, 2023

The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology, and an increased demand for accelerated timelines in getting therapies to market. Each of these have contributed to a rapidly evolving clinical research landscape.

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Clinical Trials Trials Clinical Research Research 52

Advarra

OCTOBER 31, 2023

A common misconception in the manufacturing and research development landscape is quality systems can be bought off the shelf and there are no significant differences among the proliferation of quality systems. Clinical research is grounded in scientific integrity, participant safety, and data reliability.

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Compliance Clinical Research Clinical Trials Trials 52

Advarra

OCTOBER 14, 2022

In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site. What is this innovation?

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

Conversations in Drug Development Trends

APRIL 25, 2024

Understanding and managing post-surgical pain is pivotal in clinical research for improving patient outcomes and care strategies. Here, we delve into how these challenges can be navigated with the aid of clinical assessment services, leveraging the expertise of Worldwide Clinical Trials’ Clinical Assessments Technologies (CAT) team.

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The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Find more information about AbbVie clinical trials here.

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