FDA Law Blog

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Hyman, Phelps & McNamara, P.C.

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ACRP blog

OCTOBER 19, 2022

In the turbulent waters of the clinical research workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and around the worst of the storm. “It We want to show them the options” that exist in the clinical trial industry, he adds.

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Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

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WCG Clinical

AUGUST 22, 2023

PRINCETON, NJ, August 22, 2023: WCG, the global leader in providing solutions that measurably improve the quality, efficiency, and safety of clinical research, today announces the WCG MAGI Clinical Research Conference, an educational mainstay for clinical trial professionals for more than 15 years, is going virtual for its fall 2023 event.

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ACRP blog

JUNE 30, 2023

Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Do you lose revenue in research? Are you calculating fair market value correctly?

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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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Clinical Trial Podcast

JULY 31, 2022

He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”.

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Advarra

JUNE 27, 2023

This article explores how the clinical research phases protect study volunteers from harm and ensure new drugs and therapies are developed effectively. The Importance of Clinical Research in Medical Advancements Researchers use clinical trials to test a drug’s or other medical treatment’s safety and efficacy.

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Cloudbyz

MAY 24, 2023

Clinical trials play a crucial role in advancing medical research and developing new treatments and therapies. Clinical trial data management audits serve as a critical tool to evaluate and validate the accuracy, completeness, and integrity of the data, as well as compliance with regulatory requirements.

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Cloudbyz

MAY 17, 2024

This Act is poised to significantly change the clinical trials landscape within the life sciences sector. As AI increasingly becomes a cornerstone in clinical research and drug development, it is crucial for industry stakeholders to grasp the extensive implications of this regulation.

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XTalks

DECEMBER 4, 2023

But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy. Project Optimus is intended to reform the dose optimization and dose selection paradigm in oncology drug development,” says Dr. Confeld.

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WCG Clinical

JULY 12, 2023

Princeton, NJ, July 12, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, released its 2023 Avoca State of the Industry Report. Avoca joined the WCG family of companies in April 2021. For more information, visit www.theavocagroup.com.

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Roots Analysis

OCTOBER 29, 2023

Clinical trials are prospective biomedical research studies designed to evaluate medical, surgical or behavioral interventions in people and investigate novel approaches for the diagnosis and prevention / treatment of diseases. The following figure presents the challenges associated with decentralized clinical trials.

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Worldwide Clinical Trials

APRIL 25, 2024

Understanding and managing post-surgical pain is pivotal in clinical research for improving patient outcomes and care strategies. Compliance Issues: Ensuring consistent patient participation in reporting pain levels post-surgery can be challenging.

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Drug Discovery World

DECEMBER 18, 2023

With a staggering 450,000 clinical trials 3 registered globally to address these pressing health issues, and an average failure rate of 90% 4 , the call to accelerate and revolutionise clinical research is paramount. They mark a significant shift in clinical research, utilising technology to capture real-time patient data.

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ACRP blog

JUNE 7, 2023

If you hadn’t already noticed, the clinical research enterprise has well and truly entered the era of “big data,” artificial intelligence (AI), and machine learning. It also includes search and support services that help patients understand, find, and enroll in clinical trials.”

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Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Development and Approval : Small Molecules: The pathway for development and regulatory approval is well-established, with clear guidelines for demonstrating safety and efficacy.

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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.

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Velocity Clinical Research

MAY 30, 2024

Being a clinical research site organization that deals with sensitive patient data, it is encouraging and comforting to see that these models consider privacy, security, and compliance as critical factors. Secondly, when it comes to Velocity’s own tech stack, our tech development has increased twofold.

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Worldwide Clinical Trials

APRIL 3, 2024

As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Targeted Outreac h: Developing relationships with KOLs specializing in your indication can create a referral pipeline for suitable trial participants.

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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 15, 2024

The field of clinical research will witness significant advancements in 2024. Read on to learn about the top 10 clinical trial trends for 2024, and be sure to explore and join upcoming webinars about clinical trials at Xtalks. Blockchain can enhance data security and compliance by creating immutable data records.

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Cloudbyz

FEBRUARY 29, 2024

This leads to improved data accuracy and reliability, laying a robust foundation for comprehensive safety assessments during clinical trials. Rapid Identification of Safety Signals : Timely detection of safety signals is imperative for ensuring patient safety and regulatory compliance in clinical trials.

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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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Cloudbyz

JUNE 13, 2023

Introduction: Clinical trials are essential for evaluating the safety and efficacy of new medical treatments, therapies, and interventions. Developing an accurate and comprehensive budget is crucial for successful trial planning and execution. Key Considerations 2.1 Best Practices 3.1

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Cloudbyz

FEBRUARY 29, 2024

This leads to improved data accuracy and reliability, laying a robust foundation for comprehensive safety assessments during clinical trials. Rapid Identification of Safety Signals : Timely detection of safety signals is imperative for ensuring patient safety and regulatory compliance in clinical trials.

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Cloudbyz

JANUARY 13, 2021

. ☰ Decentralized Trials will dominate Clinical Research space in 2021. Decentralized clinical trials or DCT have become the new norm for the life sciences industry. So, DCT will have a formidable impact on shaping up the clinical landscape in 2021in various aspects. Compliance. Jan 13, 2021. 8 min read.

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Cloudbyz

MARCH 9, 2023

This improves data quality and accuracy, which is critical for regulatory compliance and data analysis. Better study data analytics: Integrating EDC with other systems can improve data analytics, enabling researchers to quickly identify trends, patterns, and anomalies in the data.

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VirTrial

OCTOBER 14, 2020

VirTrial developed the program, using BlueCloud standards, while BlueCloud will provide its global networking infrastructure to Deliver, Distribute, Implement and Track (DDIT ) training competencies and certifications for business and compliance purposes. About VirTrial.

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ACRP blog

JANUARY 30, 2024

“We’re seeing significant innovations in the medical product development industry, and true innovation can cause some consternation in such a highly regulated sector,” says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, at the U.S.

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Cloudbyz

MAY 15, 2024

An eSource system not only facilitates the electronic collection and management of clinical trial data but also ensures compliance with regulatory standards, enhances participant management, and optimizes data integrity and reporting processes.

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Advarra

NOVEMBER 9, 2023

This blog explores the pivotal role QMS plays in study startup activities as well as how a right-sized QMS contributes to the overall success of clinical trials. Understanding Study Startup Activities Study startup is the phase of a clinical trial occurring after the protocol development and regulatory approval stages.

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Cloudbyz

OCTOBER 25, 2023

Naperville, Illinois – October 24, 2023 : Cloudbyz, an innovative digital clinical research solutions provider, today announced a new partnership with SPAR Solutions who provide a complete range of customer engagement solutions covering sales, marketing, service, and communities.

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Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

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Worldwide Clinical Trials

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial.

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VirTrial

FEBRUARY 4, 2020

Recognizing the need to support VirTrial’s customers around the globe, Emil Hoeck has been named International Director of Business Development and will be based in Denmark. VirTrial’s Virtual Care Management (VCM) platform is HIPAA, HITECH and Privacy Shield Compliant and VirTrial has implemented policies to support GDPR compliance.

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